Clinical Research

India is becoming a hub for clinical research; the demand for professionals in this field is growing rapidly. Clinical research business in India will be worth billion by 2010. Thus, there will soon be a massive demand for clinical research professionals, making it an interesting career option with massive growth potential.

Clinical research is all set to become the next big thing in India. A large population with a substantial workforce and cost benefits influence multinationals to set up research facilities here. Besides due to the prevalence of a large variety of diseases, including widespread cases of cancer and diabetes India is viewed the world over as the ideal location for clinical research trials for the pharmaceutical industry.

What is Clinical Research?.
A clinical research is a scientific study of the effects, risks, efficacy and benefits of a medicinal product. These are carried out prior to the release of the medicine in the market. These trials are undertaken at various stages and studies are conducted after the launch of a new product to monitor safety and side effects during large-scale use. Clinical trials are conducted by pharmaceutical companies or contract research organisations (CRO’s) on their behalf. It is this sector that is driving the growth in clinical research in India.

So, what does one need to become a part of this rapidly growing industry?

Eligibility.
B. Sc. degree is a must to enter this field. Ideally the industry is looking for science graduates from pharmacy, medicine, life science and bioscience. Within bioscience too there are various other fields such as botany, zoology, biochemistry and genetics. Anybody who fulfils these criteria can join the industry.

Individuals with prior work experience of 2-3 years are preferred, but like the BPO industry, there is a dearth of trained professionals here too. Thus, with the right qualifications finding a job in clinical research should not be a problem.

Job Profile.
Clinical Research branches off into various categories at the entry level.

The most common entry-level position is that of a Clinical Research Associate (CRA). The role of a CRA is varied,

They are key participants in the design, implementation and monitoring of clinical trials

They shoulder the responsibility of planning and implementing all activities required to conduct and monitor complex clinical trials and ensure that Good Clinical Practices are followed.

They assist in preparation of presentations and manuscripts of scientific meetings and technical journals and attend scientific/professional meetings and training courses as appropriate.

BIOSTATISTICIAN are those who,

Perform statistical programming, design, and analysis for clinical trial projects. Planning, coordinating and providing statistical analyses, summaries and reports of studies is also a part of their job profile. In addition they are responsible for New Drug Applications and Biological License Applications submissions.

CRM are Clinical Research Managers,
They supervise design and writing of protocols, case report forms and informed consent forms for clinical trials. They ensure that Case Report Forms are reviewed in a timely fashion and submitted to the data management group. There are other posts too such as Clinical Research Coordinator, Business Development Manager, Clinical Research Investigator, Clinical Data Manager etc.

Where to Study?.

Academy for Clinical Excellence (ACE) Website: www.aceindia.org It offers courses like Clinical Research; From Theory to Practice, clinical Research and GCP for investigators, Quality assurance in clinical research etc.

Institute of Clinical Research (ICRI) Website: www.icriindia.com It offers the following courses:

Two year full time – Masters in Clinical research + MBA

Two year full time – MSC in Clinical Research

Part-time post graduate diploma in Clinical Research (1 year)

PhD in Clinical Research.

Bombay College of Pharmacy: Website: www.bcpindia.org Offers Bachelors, Masters, and Doctoral programme of study in Pharmaceutical Sciences.

Cliniminds – Academy for Clinical Research Training & Management – Website: http://www.cliniminds.com – institute offers wide range of clincial research courses; diploma programs in Pharmacovigilance; Quality Assurance in Clinical Research; Biostatistics; Investigators; GCP Training; Monitoring and several other programs.

Editor’s Note: Fermentation industry is the most ancient traditions of the industry, but large quantities of drugs as medicine, modernization and automation of industrial production booming, production equipment and technology in China far below the requirements of the fermentation process is increasingly exposed. In which the valve leak is more common and more harmful situation, this, in valve production for nearly 40 years Wenzhou Long Point Company, has focused on anti-leakage, Bacterial contamination of the valve to avoid research and development. The show, heard machine Ningbo Dragon Pharmaceutical Special Exhibition Out a new type of antibiotic multi-function valve, then the general situation on the product editor Ben Wang interviewed Mr. Chen Guoping, general manager.

Special Valve Co., Ltd. Wenzhou Long, Chairman and General Manager Mr. Chen Guoping

HC Net : Your business is the national medical biological and chemical systems and the origin of special valve production base, heard the company now launched a new product, so first of all President Chen introduce the new product development situation.

President Chen: Valve is every pharmaceutical, biotechnology companies indispensable as the main force, especially in the fermentation and extraction plant, which is used to cut or communication steam, water, media, air and other fluids regulate the fluid flow, control Pipeline Or container pipeline pressure control of essential items. The fermentation process of the pharmaceutical industry, the biggest problem is leaks and jars. Common valve used for fermentation, often in run, run, drip, drain phenomenon; In addition, pharmaceutical raw materials in the fermentation of mostly rice, corn, etc., the same as wine produced by fermentation of fungi, but if not Protection Well, more than 48 hours after the fermentation Bacterial contamination which would likely form a bacteria source pollution, then they all scrapped materials. In response, many pharmaceutical companies have told us over this issue. In such cases, to meet customer demand, we will proceed from the last year in the original Antibiotic Development of new products based on the valve. “Hard work pays off,” on May 18 this year, Ningbo Pharmaceutical Machine Show on the eve of finally succeeded, and this new product is a new type of antibiotic you are seeing multi-function valve. It is an alternative antibiotic valve, efficacy than 3-fold increase, to ensure zero leakage, resistance to bacteria.

HC Network: New multi-function valve that antibiotics than other similar products What are the advantages characteristic?

President Chen: The new product has now applied for four patents, including the new utility patent, the internal structure of patents, design patents, and world patents. The biggest feature is to Throttle , Valve , Diaphragm Valve Three different valves for the integrated, breaking the original valve sealing performance is poor, Diaphragm temperature completely below standard, many pharmaceutical companies rely on high import similar products to maintain status quo operations, so that the original great condition have changed. In addition, the domestic pharmaceutical and chemical, biological and other related areas of business a rough estimate there are about 10,000 more than their throttle valves, diaphragm valves, three valves on one-year maintenance costs nearly two million, and if with our valve, they can save 2 / 3 of the money, thus greatly reducing the cost has really been able to spend the same money to buy three things, why not? Another point is that the valve Parts Is a wildcard, because it is made of CNC machining, so no matter where it was taken can be uniformly used.

HC Network: It appears that the new valve does have many superior to others, its design and manufacturing process, presumably also in possession of a lot of mystery, right?

President Chen: Indeed, the valve design is the key Body Design, body structure, though the ever-changing, but a clear functional division of the two sections is always the same. Longitudinal section of body fluids to determine the flow of fluid cross-section to determine the fluid flow through the cross section area, according to fluid mechanics, combined with the pharmaceutical industry GMP Certification Standards, we designed the valve in longitudinal section after the first, conical section, the formation of the swirl flow so that material quickly left the valve. There is no inflection point throughout the process line, without any dead ends to the flow direction and channel the shape of the phenomenon does not occur, and to fluid retention without resistance purposes. The valve body seal ring contact surface designed to trumpet, to emit the same material as the fountain is beneficial to the working medium flow. Added at the bottom of valve body vent hole, that is conducive to the beginning of production in the sewage pipe gas emissions, but also conducive to the production process of disinfection.

Another point is the choice of sealing materials, pharmaceutical companies will be under different conditions required in the selection of appropriate materials, has been equipped with heat resistance, abrasion resistance, alkali resistance, acid resistance different scenarios. Same time, because long-term sealing surface at higher temperature and pressure to work under a variety of media corrosion and erosion, and some still bear the wounds Sassafras between the sealing surface wear. Therefore, we use high-tech laser focused by a laser surgery to seal the valve body and valve flap single-channel laser scanning levels to achieve a laser cladding Co-based or Ni-based alloy layer thickness up to 3mm, so Coating That smooth, can increase the hardness of 20% ~ 40%. Testing and production shows that the treatment by laser cladding valve sealing surface in bad condition with good resistance to wear, cavitation erosion resistance, corrosion resistance, fatigue resistance and high temperature shock fatigue performance benefits, thereby increasing the valve Use of reliability, safety, and extend its life.

Bronte novel antibiotics multi-valve HC Network: It is understood that this new type of antibiotic multi-function valve was the first time to meet with customers, but there are a number of pharmaceutical companies have been consulting to the Long Point and order, the specific situation is like?

President Chen: The new valve can be said for an occasional, very broad market prospects, according to an analysis of pharmaceutical industry professionals, the product can be achieved in the country 10 billion a year sales. So the past few days show that there are many customers come here especially. Yesterday (May 20) Core Group’s work on the Eagle came to see products, and on the interest. According to him, on July 1, erythromycin production factory to be launched, let us show drug plane after the end of this valve samples immediately send them over and that the plant is fermented very need this. Henan boss of a pharmaceuticals manufacturer, exhibitors manager came to our booth, and the factory is our old customers, previous antibiotic use is the valve, the heard of Long Point has introduced a new valve, so take a look, Finally, they set a standard of 20. The exhibition is a great harvest we.

HC Network: Long Point now has such a good

Hi, I was wondering if you do any marketing research online? If you do I’m pretty certain you have heard about Brad Callen’s keyword research tool which is also a keyword generation tool, called Keyword Elite. If you have never heard of this keyword research tool then you are probably wondering what all the fuss is all about.

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The choice of hiring a business plan writer who focuses on the writing of the plan and preparation of the final documents only, versus a business plan consulting firm which can take you through the entire business plan development process, depends on where you are with your understanding of what the business plan should express.

When to Hire a Writer

If you have a strong handle on how to do the research required for your business plan (research into the industry, customers, competitors, startup costs, etc.) and on what a successful strategy for this business will look like, you are probably just in need of an experienced business plan writer to draft it into convincing narrative and prepare the final document. When you can answer the questions required of each section of the standard business plan outline, even jotting it all in  bullet point format, a writer can take you the rest of the way.

Furthermore, if you know how to read financial statements and can evaluate the work of a writer you hire to prepare them, you are in the right situation to work with a business plan writer.

When Not to Hire a Writer

When you are not in the situation just described, hiring a business plan writer is putting the cart before the horse. He or she can document what you already know, but this may be documenting a half-formed strategy based on minimal research. The result may very well be in the perfect business plan format and structure, but will not present a convincing argument to any funders.

It is in situations like these where entrepreneurs should seek a business plan consultant or consulting firm which can shepherd them through the rest of the business plan creation process. Such a firm can make strategic recommendations about how to act upon the opportunity at hand and how best to present the plan to investors. They can also undergo a great deal of research and financial preparation themselves, assisting those who don’t have the ability to do this kind of work easily.

Part 1 of Culture of Insight’s research into how market research can increase its value to the media and advertising business.

Key pad voting system is an Interactive voting system for the audience. All service providers need a response to turn into a user oriented output. Whether it is a market research for product analysis, or training systems to gain the feedback of trainer in the view of the trainees, a feedback gives the idea of system or any service provider’s effectiveness.

Audience response is also required in the departmental meetings, training workshops, Medical symposiums, market research and a lot more. It has become essential to seek the seekers perspective. And that is best done by getting the audience response.

A keypad voting system is a system of wireless keypads used by a presenter to poll the audience and receive real time answers to the questions being asked. It consists of various components such as wireless keypad for the audience to feed response, a software system to capture response, a storage device to save and finally a display unit to display the data collected.

When the presenter shows the presentation with a computer that have built in ARS software; questions are displayed on the screen and audience responses with the wireless keypads.

The answers are immediately sent to a receiver that is attached to the presenter’s computer, and the audience response software collects and tabulates the results and graphically displays representation of the data within the presentation.

Become an ARS meeting master

To list a few essentials of Keypad Voting Systems, I can say that the important thing is the ability to restore attention of the audience. If you are getting the attention of audience then it means there is a true feedback.

Any Electronic Voting System should also be capable of tracking individual responses and displaying polling results immediately. And an added feature could be that a summary report should be created immediately after the responses are gathered. This will give the true picture of the audience response and enhance faster decision making.

PowerCom software and ARS together can create miracles in your work. The best thing is that data is transferred to PowerPoint presentations, word and excel spreadsheets.

A keypad is a key pad

The digit key 1 through 10 are used to enter the numeric responses, including multiple choice questions A through E or yes/no answers, into keypad memory. The key must be released to allow the next key press to occur. The entries are transmitted to the Reply Base Station, which is then transmitted to the computer. When the keys are pressed, the digits are echoed on the seven-segment display (SSD).

Normally the displayed digit will go out within 3 seconds. This indicates to the user that the base Station has accepted the entry and the hardware is operational. If the light blinks and comes back on, this means that the Base Station addressed the keypad but was not able to accept the entry.

Where do we use keypad voting system?

The core areas in which Audience Response Systems used are education and learning, training held in Corporate, Game shows , conferences and events, surveys and research, sales, marketing, polling and voting, Decision makings.

Whether we are doing research for products analysis, education or whether we are doing medical symposiums or management meetings we use keypad voting system to get the feedback of people as it gives the idea of system and our area of improvements as well as our strengths.

Keypad voting system in marketing research

This is no amazing thing if I would say that several voting handsets has been sold from last few years .And again a high percentage of handsets are predicated to be sold.

To cope up with the present scenario in the market for future prospective some companies are initiating approaches of keypad voting System to know the needs and choices of customers and clients. They arrange polls to know the interests of their clients and customers.

This doesn’t require the high tech hardware and are really appreciated by professionals and large meeting halls that do not want to purchase or rent out the Audience Response System hardware.

In marketing research many companies have successfully used the product to get the response of customer and find their fields of improvements.

    Recently, the Chinese Medicines & Health Products Import and Export Chamber of Commerce will be the nation’s first “Chinese Herbal Pieces export base” grant Bozhou City, to further promote the city’s Chinese Herbal Pieces exports, promote rapid and healthy economic development of traditional Chinese medicine and Chinese medicine international.

    From January to July of this year, the city exported 11.6 million U.S. dollars medicine, an increase of 91.9%, accounting for three-quarters of the province’s exports of medicinal herbs, emerged Concorde into medicine, medicine, and so mm wide group of key export enterprises of Chinese medicine, Chinese medicine Slices has become the city till the province’s exports of agricultural products, one of the major growth point.

    Bo at this year’s medicine by the Chinese Medicine & Health Products Import and Export Chamber of Commerce awarded the nation’s first “Chinese Herbal Pieces export base,” unveiled in the city, allowing Bozhou medicine community excited. The industry generally believe that this is bound to promote the city’s export industry, the development of Chinese Herbal Pieces, cultivating the city’s international competitiveness in traditional Chinese medicine companies play an important role.

 

    Prominent Chinese Herbal Pieces export advantages our city

   ”Bozhou is a skilled doctor Hua Tuo’s hometown in history is our main production base of Chinese Herbal Pieces and distribution centers in the world.” Chinese Medicine & Health Products Import and Export Chamber of Commerce, commented Yan Hao Tong, vice president of the Pieces Bozhou industry, “In recent years, Bozhou Pieces of Chinese medicine has been the rapid development of exports, has become the most development potential of China’s export bases of Chinese Herbal Pieces. ”

 

    At present, the city’s Chinese herbal medicine Chinese herbal medicines planted acreage accounts for 11% of the total area, the existing processing enterprises in nearly 50 traditional Chinese medicine, Chinese Herbal Pieces Pieces total production output accounting for about 1 / 4, engaged in the production and marketing of Chinese herbal medicine staff nearly 100 million people, is the country’s largest trading center of Chinese herbal medicines, and Slices processing base. City in the pharmaceutical industry has formed a relatively complete industrial system, pharmaceutical economy has become the city’s economy with local characteristics.

 In particular, exports in the Chinese herbal medicine is even more impressive, from January to July this year, the city exported 11.6 million U.S. dollars medicine, an increase of 91.9%, accounting for the province’s exports of medicinal herbs 3 / 4, Concord emerged into medicine, mm Canton medicine, Chinese medicine Shenglin medicine, and so a number of key export enterprises. As the Pharmaceutical Export has a pivotal position in the province, the city Commerce Department has also been named as the “modern traditional Chinese medicine export innovation base.” Today, Chinese Herbal Pieces Bozhou has become the province’s exports of agricultural products as well as the major growth point.

 

    Chinese Herbal Pieces export prospects

    Pieces of Chinese medicine in Bozhou a time when industry is flourishing, the current pace of development in the global pharmaceutical market is also growing steadily, in this favorable opportunity, the city’s exports of Chinese Herbal Pieces facing broad prospects for development.

 

    Chinese Medicine & Health Products Import and Export Chamber of Commerce, Yan Hao Tong, vice president of analysis that 21st century will be the century of biotechnology and life sciences, biotechnology and pharmaceutical industries will occupy in the new century, a more important role in the global pharmaceutical market is at twice the rate of economic development, steady growth in 2006 reached 643 billion U.S. dollars. In particular, Chinese medicine in China, but also by the whole world welcomed in the international market step by step from civil society into the mainstream society, is for the life and health of people around the world are playing an increasingly important role.

 

    In this regard, the Deputy Commissioner of the Ministry of Commerce in Shanghai, Yang Hongbin, also holds the same view, he believed that China’s medicine industry is the economic and social development in a broad market prospect of the strategic industry. Currently, herbal and plant extracts market, 10% annual rate of 20% of the rapid development, the annual trade volume of more than 30 billion U.S. dollars. However, China’s exports accounted for only about 2% of the world, which for us that a country has a long history of TCM, this is grossly disproportionate. He said that in the future, the Ministry of Commerce will continue to support the development of Chinese medicine in China for export expansion to give a positive support.

    Chamber of Commerce to help Bozhou Pieces to the world

    Pieces of Chinese medicine in the city to develop export industries in the process of Chinese Medicine & Health Products Import and Export Chamber of Commerce will play a positive role in what does?

    It is understood that Chinese Medicine & Health Products Import and Export Chamber of Commerce is subordinate to the Ministry of Commerce of Commerce is one of the six largest import-export, domestic trade in medicines and health products the most authoritative and most representative business organization, there are currently more than 1,500 family member. In addition to participation in government policy-making, participation in international markets, exchanges and government negotiations, the most important tasks of the Chamber of Commerce is to help enterprises to enter the international market.

 

    In the municipal government and Traditional Chinese Medicine & Health Products Import and Export Chamber of Commerce signed a cooperation agreement that the parties will jointly organize a “Pieces of Chinese medicine export base” building working group, and use their respective channels to promote each other. Pharmaceutical Import & Export Chamber of Commerce will manage domestic and international regulations, procurement information, Chamber of Commerce will be information on training, professional seminars, industry data to provide timely information to the city in order to enhance exchange of information.

 

    Meanwhile, the Chinese Medicines & Health Products Import & Export Chamber of Commerce group in the Fair Hall arrangement, outside the product registration, import and export certification, import and export of endangered wild animal and plant products, traditional Chinese medicine health care products, and licorice pre-nuclear signatures of commodities such as tendering, business and product promotion, brand in terms of nurturing the city’s member companies to provide facilities and concessions; in the Chamber of Commerce, involved in the implementation of the national pharmaceutical industry to support the development of policy and funding priority would be to support the city eligible member enterprises, member enterprises to the city’s Introduction of foreign customers and partners, helping to establish and develop business partnerships, the introduction of new products and new technologies.

 

    In addition, the Chamber of Commerce will be in anti-dumping, countervailing and other international trade disputes should, in order to provide guidance and assistance to city business, on behalf of industry, external consultations and negotiations, make every effort to eliminate technical barriers to trade and trade barriers, reduce the city’s international business the loss of trade.

 

   ”Establishment of Chinese Herbal Pieces export base, for the pharmaceutical industry to play a Bozhou advantages and further promote the Chinese medicine Bozhou rapid and healthy economic development, and promote the internationalization of Chinese medicine has great significance.” Chinese Medicine & Health Products Import and Export Chamber of Commerce vice president Hao Tong Yan pairs base prospects in China.

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Abstract

This paper is concerned with the impacts of strict patents in the pharmaceutical industry, focusing on the Trade Related Aspects of Intellectual Property Rights (TRIPs) Agreement. It discusses the historical and current policy context, to better understand how strict patents affect the availability of essential drugs in developing countries.

The research shows that the pharmaceutical industry prioritises profit above health. Strict patents reduce the availability and affordability of new essential drugs in developing countries, and thereby have a negative impact on the health of the world’s poor. Larger pharmaceutical companies benefit more than smaller companies because they have a monopoly in the industry. They invest more in research and development and, linked to economies of scale, are better positioned to exploit markets for new drugs.

The example of India highlights the importance of generic production and essential drugs in developing countries. It shows that while TRIPs promotes economic growth of the industry and encourages investment in research and development of new drugs, it increases the prices of new essential drugs, thereby isolating benefits from the majority poor populations in developing countries.

The paper suggests that based on historical and current trade policy, developed countries have an ethical obligation to allow poorer countries to develop infrastructure for their pharmaceutical industry, a responsibility not being fulfilled. It suggests TRIPs be revised under a more ethical framework. This includes increasing public funding of research and development, shortening the length of patents and allowing developing countries to generically produce essential drugs.

The paper highlights the interconnectedness of social, economic and political factors that could increase the availability of essential drugs in developing countries. It highlights the importance of better understanding the issues surrounding strict patents, and why the scientific community is critical to this process, in terms raising awareness and collaborating with independent organisations and concerned citizens to ultimately press governments for change at the national and international level.

Table of Contents

1. Introduction

1.1 What are Patent Laws?

1.2 What is TRIPs?

1.3 Focus and Structure of the Paper

2. Pharmaceutical Industry for Profit or for Improving Health?

2.1 Scale of Profits

2.2 Investment Priorities

2.3 Diffusion

3. Essential Drugs and Generic Production

4. Impacts of TRIPs

4.1 Main advantages

4.2 Main disadvantages

4.3 The Doha Agreement and Compulsory Licensing

5. Conclusions

6. References

1. INTRODUCTION

‘As the ancient scourge of polio was rolled back by his vaccine 50 years ago, Jonas Salk, the inventor of the polio vaccine was asked why he never took a patent out on the medicine, a patent that would have made him wildly rich. “There is no patent,” he replied … “Could you patent the sun?”’ (Salon.com magazine 2001).

This paper explores the impacts of pharmaceutical patents on drug availability in the third world, focusing on the impacts of the Trade Related Aspects of Intellectual Property Rights (TRIPs) Agreement. It highlights the value of essential drugs and generic production in developing countries, using India as a case study. It also explores alternatives to TRIPs and the role of the scientific community.

1.1 What are patent laws?

A patent can be defined as ‘a monopoly right granted to person who has invented a new and useful article, an improvement of an existing article or a new process of making an article’. It consists of an exclusive right to manufacture the new invented article, or manufacture an article according to the invented process for a limited period. During the term of patent, the owner of the patent, i.e. the patentee can prevent any other person from using the potential invention .

Figure 1: Brief History of Patent Law

The timeline below illustrates the brief recent history of patents in the world .

1880-1882

Patent statutes introduced in most European countries

1883

Paris Convention for the Protection of Industrial Property – cornerstone of the modern international patent system.

1947 International Patent Institute (IIB) established at the Hague

1970

Patent Co-operation Treaty signed in Washington, D.C.

1978

International Patent Institute integrated into the European Patent Office (EPO)

1979

Bayh-Dole Act passed-granted permission to U.S. universities to license and profit from federally sponsored research*

1980

International Patent Documentation Centre (INPADOC) integrated into the EPO

In the pharmaceutical industry patents have a straightforward objective. They provide a strong incentive for companies to invest in the research and development of new drugs, knowing that they will be able to recuperate costs and, subsequently, profit from the new drug. However, patents enable parent companies to control the price and availability of new drugs. There is no competition from other companies to produce the drug, which would usually lower the price. Thus, increasing the length of patents can reduce the availability of new essential new drugs in developing countries, with knock on health problems.

Essential drugs can be broadly defined as those that satisfy the health care needs of the majority of the population. They should, therefore, ideally be available at all times in adequate amounts; in the appropriate dosage forms; at reasonable (affordable) price; and, meeting the criteria of quality, safety and efficacy (New Strait Times 1998).

Under the term of a patent, drugs, essential or non-essential, can only be produced by the parent company. This means that there is no competition from other companies to produce the drug, and the parent company can charge a high price for the drug, effectively making the drug unavailable for poorer people.

New drugs tend to be more available to developed countries, because people are more affluent and can afford higher prices. For this reason, pharmaceutical companies tend to market their drugs at developed countries. Overall, developed countries benefit more from new technology and advances in science because their governments, companies, and people can afford to buy into the technology.

The World Trade Organisation’s (WTO) Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement, which extends the length of patents, enables companies to significantly increase their profits and increase the technology gap between developed and developing countries.

1.2 What is TRIPs?

The Trade Related Aspects of Intellectual Property Rights (TRIPs) was added to the General Agreement on Tariffs and Trade (GATT) at the end of the Uruguay Round of trade negotiations in 1994. It came into full force in January 2005, and its inclusion by the World Trade Organisation (WTO) was the ‘culmination of a program of intense lobbying’ by the United States, supported by the EU, Japan and other developed countries .

The United States strategy of linking trade policy to intellectual property standards can be traced to senior management at Pfizer (a large United States pharmaceutical firm) in the early 1980s. Pfizer mobilised corporations and made maximising intellectual property privileges the number one priority of United States trade policy .

According to the WTO, ‘TRIPs is an attempt to strike a balance between the long term social objective of providing incentives for future inventions and creation, and the short term objective of allowing people to use existing inventions and creations’ .

The following requirements of TRIPs all have a bearing on the pharmaceutical use of patents .

? Copyright must be granted automatically, and not based upon any “formality”, such as registrations or systems of renewal.

? National exceptions to copyright (such as “fair use” in the United States) must be tightly constrained.

? Patents must be granted in all “fields of technology” (regardless of whether it is in the public interest to do so).

? Exceptions to patent law must be limited almost as strictly as those to copyright law. In each state, intellectual property laws may not offer any benefits to local citizens which are not available to citizens of other TRIPs signatories (this is called “national treatment”). TRIPs also has a most favoured nation clause.

? Patents in the pharmaceutical industry will apply for 20 years, instead of 10 to 15 years.

Some developing countries began to grant their own patent protection in the late 1980s, but TRIPs is a compulsory requirement for any country who wants to be a member of the World Trade Centre, and with that memberchip access to international markets and trade relationships. Countries which do not adopt TRIPs can be disciplined through the WTO’s dispute settlement mechanism, which is capable of authorising trade sanctions against dissident states . Therefore, the economic and poltical threats, which could cripple a poor economy, effectively forced developing countries to ratify the agreement.

The TRIPs agreement makes it easier to obtain and enforce patents. It increases the length of pharmaceutical patents, from 10 to 15 years to 20 years, which encourages companies to invest more in research and development and promotes economic growth. However, it favours developed countries, which have the capacity to enforce their rights globally, and create more exclusive trade options under the Intellectual Property Rights (IPRs). Developed countries have more pharmaceutical infrastructure and companies that are used to using patents to make profit.

1.3 Focus and structure of this paper

Chapter 1 introduced the main contentions of using strict patents in the pharmaceutical industry. It explained how patents work, and the main changes that TRIPs will make to the pharmaceutical industry.

Chapter 2 shows the monopoly of a handful of large pharmaceutical companies in the pharmaceutical industry. It provides a sense of the scale of the profits made by these companies, contrasting the investment priorities and types of drugs produced with those that are needed in developing countries. The Chapter debates whether the industry is for profit or health, briefly highlighting how companies make false claims through advertising in developing countries.

Chapter 3 introduces the idea of essential drugs and generic production, exploring the benefits with a case study of India. Chapter 4 shows how TRIPs will restrict generic production of essential drugs, and the impacts this will have on the majority poor populations in developing countries. The conclusion, Chapter 5, suggests how TRIPs could be revised under a more ethical framework, exploring the historical and current drug policy context, with particular emphasis on the role of scientists.

2. PHARMACEUTICAL INDUSTRY FOR PROFIT OR HEALTH?

In an attempt to understand how pharmaceutical companies control the availability of essential drugs, and use patents to make substantial profits, this chapter debates whether the pharmaceutical industry is for profit or health. It looks at the scale of profits made by the pharmaceutical industry and their investment priorities, also challenging whether ‘diffusion’ of biotechnology works to provide essential drugs to developing countries.

2.1 Scale of profits

There is a very familiar trend in the international pharmaceutical industry. A handful of multinational companies, originating from developed countries, have a great deal of economic power, which gives them control over drug availability and health. They also lobby governments to make trade policy which suits their profit making agenda. In 1996 the first ten multinational pharmaceutical companies accounted for approximately 36 per cent of the world pharmaceutical sales of US$ 251 billion .

Table 1: The World’s Top Ten Pharmaceutical Companies in 2003

Company Pharma Profit ($million) Pharma Sales ($ million) Pharma Operational Profit Margin

Pfizer 12,920.0 28,288.0 45.7%

Merck & Co. 10,213.6 21,631.0 47.2%

GlaxoSmithKline 7,598.2 26,979.0 28.2%

Johnson & Johnson 5,787.0 17,151.0 33.7%

AstraZeneca 4,006.0 17,841.0 22.5%

Novartis 3,857.3 13,497.4 28.6%

Wyeth 3,505.5 12,386.6 28.3%

Aventis 2,969.6 15,705.4 18.9%

Abbott 2,739.0 9,304.0 29.4%

Takeda 2,446.6 6,838.3 35.8%

Group Subtotal 56,042.9 169,621.8

Average 31.8%

Source: Adapted from Scrip Report 2003

The pharmaceutical sector racks up the largest legal profits of any industry, with an average 18.6 % return on revenues in 2001 (Resnik 2001).

However, Table 1 shows that the top ten companies achieved a much higher average profit margin of 31.8% in 2003. Thy have a monopoly over the industry. Linked to economies of scale, larger companies can exploit larger market penetration to increase their profits. For example, Pfizer and Merck & CO, two out of the top three pharmaceutical companies in 2003 according to gross sales, had a profit margin of 45.7% and 47.2% respectively. This was much higher than the average profit margin of the top ten companies (31.8%), which illustrates the relationship between economic power and power of market exploitation.

The pharmacetical industry justifies their high profits with the argument that a great deal of time and money is invested in the research and development of new drugs. In 1998, developed countries spent US0 billion on research and development, more than the total economic output of the world’s poorest 30 countries. In 2003, it was estimated that the average cost of producing a new chemical compound is around US$ 200 million . Thus, the industry is keen to protect their investments and subsequently reward their efforts by making a great deal of profit. However, there are ethical issues as to whether the scale of the profit can be justified, given the healthcare problems that exist in developing countries resulting from the unavailability of essential drugs.

Large pharmaceutical companies maintain their monopoly by investing great sums in legalities to lobby governments into protecting the industry, by making strict patent law. ‘The combined worth of the world’s top five drug companies is twice the combined GDP of all sub-Saharan Africa and their influence on the rules of world trade is many times stronger because they can bring their wealth to bear directly on the levers of western power’ (Borger 2001).

One of the leading US biotechnological companies, Genentech, has four times as many lawsuits to protect its patents as it has products (Fowler 1996). At least one company has been created in the US whose ‘main business,’ according to the Wall Street Journal, ‘is buying up broad patents and then sueing other companies for alleged infringements’ (Fowler, 1996).

Thus, there is also the issue that investing so much money and time in litigtion is highly unproductive, when this money could be better spent on research and development of new drugs, and subsidising the cost of essential drugs in developing countries.

2.2 Investment priorities

The world market for pharmaceuticals shows a clear division: non essential drugs are produced and targeted at developed countries promising high profits, while developing countries are still in need of basic healthcare and essential drugs.

Of the 1223 new drugs marketed between 1975 and 1996, only 13 were developed to treat tropical diseases – and only four were directly the product of pharmaceutical industry research. In recent years, drug companies have produced thousands of new compounds but less than 1% are for tropical diseases .

In 1998, global spending on health research was US billion , but 90% of the money spent on health research and development focuses on medical conditions responsible for only 10% of the world’s burden of diseases (Benatar 2000). Only US0 million was dedicated to research for vaccines for HIV/AIDS and only US0 million to malaria research, diseases with the highest mortality and morbidity rates in the world, and devastating in developing countries.

‘It would be more profitable to develop a drug designed to enhance sexual performance for Anglo-American males than to develop a medicine designed to treat or prevent malaria’ (Resnik 2001).

There is also the suggestion that pharmaceutical companies focus more effort on a certain drug in developing countries when it is in their research interest; “Of diseases in the Third World, AIDS is getting the most attention and focus. Not coincidentally, it is also one of the few diseases that remain a threat to First World countries” (Censored 2000).

Pharmaceutical companies are able to devote their resources to non-essential drugs targeted at the richer markets of developed countries and at the same time, exploiting the markets in developing countries by influencing the world price for drugs. For example, pharmaceutical companies have long resisted “differential pricing” on their US,000-a-year courses of anti-AIDS drugs, which would allow a course to cost less in Cameroon than in Canada . Thus, the effect of purchasing power parity means that the prices are even higher in real terms in developing countries.

Drug Aid

In many cases, drug companies will provide drugs to developing countries at cheaper cost as aid. For example, in March 1998 Glaxo Wellcome (UK) announced that it would sell its anti-HIV drug AZT for 70 per cent below the normal price to pregnant women in developing countries . However, drug aid is not always beneficial. Reich et al (1999) found that out of 16,566 drug donations shipped from the US to 129 countries between 1994 and 1997, 10-40% were listed on neither the national essential drug lists nor the WHO model of essential drugs in developing countries. Also, 30% of shipment items had a year or less of shelf life (ibid.).

Advertising and false claims

There is also evidence that companies, in addition to prioritising non-essential drugs for developed countries, exploit markets in developing countries by convincing people that they need non-essential drugs. A survey, in the Annals of Internal Medicine found that ‘62 per cent of the pharmaceutical advertisements in medical journals were either grossly misleading or downright inaccurate’ (Madeley 1999).

There has been much criticism of the advertising in developing countries, claiming it is particularly persuasive in nature and that people are misinformed and encouraged to believe wild promises. This illustrates the exploitative nature of the pharmaceutical industry, and the quest for profit at the expense of health.

“In the corporate headquarters of major drug companies, the public relations posters display the image they like to present: of caring companies that bring benefit to humanity, relieving the suffering of the sick. What they don’t say, is that, so far, their humanity has not extended beyond the limits of the pockets of the sick” (Hilton 2000).

In summary, the pharmaceutical industry is for profit. A handful of economically powerful companies use economies of scale to exploit the markets of developed and developing countries. As a whole, the pharmaceutical industry is:

? Priortising investment in non-essential comfort-oriented drugs for the wants of the more affluent in developed countries, whilst neglecting the needs for essential drugs for poorer people, particularly in developing countries.

? Investing heavily in litigation and patents to restrict competition from other companies, and enable control over the price and availability of drugs.

? Exploiting people in developing countries, using persuasive advertising to make false claims.

? Motivated by profit, not health.

As Smith (1994) points out, ‘There is a direct conflict between the pursuit of health and the pursuit of wealth.’

2.3 Diffusion

Policymakers and representatives of the pharmacetuical industry argue that relevant technology reaches poorer people by means of ‘diffusion.’ This describes the process by which drugs become available to the poor after patents expire, and when competition to make the drugs drives down the prices of the drugs so that poorer people can afford them. However, as agents of disease, including bacteria and viruses, are continually adapting to drugs and developing resistance to them, new drugs are often essential and life saving, which means it is critical they are available very soon after production in developing countries. Patents reduce the availability of new essential drugs, because they increase the time it takes for diffusion to take place, if it happens at all.

The lack of infrastructure in developing countries makes it difficult for essential drugs to reach those who need them, which can increase the time it takes for technology to ‘diffuse’ to the poor, even after patents have expired. For example, oral rehydration therapy, a simple and cheap salt-and-sugar solution, has been mass distributed since the 1980s and has greatly reduced child deaths from diarrhoea, ‘but even though it only costs 10 cents a sachet, it is still unavailable for 38% of diarrhoea cases in Third World countries.’ Another example, Penicillin, discovered in 1928 and first marketed in 1943, is unavailable to 2 billion people. (Healey 2001)

The unavailability of essential drugs therefore extends beyond a lack of access to new drugs designed to treat devastating infectious diseases [essential drugs] (Resnik 2001). 50% of people in developing nations do not have access to even basic medications, such as antibiotics, analgesics, bronchodilators, decongestants, anti-inflammatory agents, anti-coagulants and diuretics (Reich 1979-1981).

In the 1980s structural adjustment programmes were enforced on developing countries by the International Financial Institutions (IFIs), such as the World Bank and International Monetary Fund. These trade liberalisation policies involved the establishment of ‘export-processing’ zones, which offered financial incentives, such as tax concessions, to companies. By favouring privatisation and encouraging multinational companies to move their operations to developing countries, one of the supposed objectives of economic liberalisation was to assist ‘development’ and the transfer of pharmaceutical technology to developing countries.

However, there has been a lack of ‘diffusion’ of knowledge and technology. In fact, it is the lack of technology transfer measures in export-processing zones that attract pharmaceutical multinational companies. With firm control over technology, even when high-tech methods of production are used they can be kept away from the domestic economy. The southern Indian city of Bangalore has, ‘thanks to Western companies’ passion for outsourcing, grown into one of the world’s premier technology hubs and is the centre of the India’s growing IT industry’ (its export revenues rose from US0 million in 1990 to billion in 1999). However, areas surrounding Bangalore are in fact extremely ‘low-tech’. In Karnataka (also state capital), there were still only 2.73 internet connections per 1000 people in 1999; in even poorer states (like Orissa), that rate dropped to 0.12 connections per 1000 people.

‘As it turned out, there has been virtually no transfer of relevant technology by these companies to developing countries … in fact, by using the power that control over technology brings, they have eliminated many potential competitors and prevented indigenous pharmaceutical industries from developing to meet the real needs of the people of the third world’ (Kanji et al 1992). Thus, the evidence leads me to personally agree with this line and disagree that diffusion can be relied upon to make essential drugs available at times when they are needed most in developing countries.

Multinationals provide employment in developing countries, it is typically very low paid with little security, and the products (and the techniques and profits) go back to the companies of developed countries. Unfortunately, even though direct foreign investment provides low-paid jobs and does not transfer technology, those jobs are still vital for many that live in poverty and have limited employment options. This highlights why re-regulation of the corporate sector is required so that markets meet certain social criteria. For example, interfering with markets to reduce the price of essential drugs in developing countries.

“Pharmaceuticals, they are a commodity. But they are not just a commodity. There is an ethical side to this because they’re a commodity that you may be forced to take to save your life. And that gives them altogether a deeper significance. But they [big pharmaceutical companies] have to realize that they’re not just pushing pills, they’re pushing life or death. And I believe that they don’t always remember that. Indeed I believe that they often forget it completely.” (Drummond 2003)

3. GENERIC DRUG INDUSTRIES AND ESSENTIAL DRUGS

In many countries with large poor populations, such as Argentina, China, Egypt and India, national policy enabled a locally financed pharmaceutical industry to develop almost exclusively engaged in manufacturing generic drugs. These industries could ‘copy cat’ certain drugs and in some cases the manufacturing processes of other pharmaceutical companies.

This Chapter illustrates the main benefits to health of generic production in developing countries, in terms of increasing the availability of essential drugs. It uses India as a case study.

Benefits

In countries with generic drug industries, drug prices are low because the primary national objective is for the government to provide affordable drugs for its people, and develop the industry for economic welfare and greater self-sufficiency. India holds a record, with prices for many drugs 10 to 100 times lower than in developed countries. The introduction of generic antiretroviral drugs by Indian companies reduced the price of these drugs by 97% (Henry et al 2002). Research and development efforts by generic drug industries have also led to the development of vaccines against leprosy and hepatitis B, and anti-cancer drugs .

Multinational companies have less economic control over the market because the domestic drug industry controls the domestic market. Therefore, poorer people are less dependent on multinational companies and the extortionate prices that they can charge for drugs. In addition to lower cost, as will be seen from the case study of India, generic drugs have the advantage of being competitive in quality to those produced by large multinationals, originating from developed countries.

A case study of India

In India, multinationals held only a 20 per cent market share in 2000 : national pharmaceuticals have gained knowledge and capacities in research and development, which has enabled them to replicate manufacturing processes for already known drugs, and develop a bulk drug industry for various chemicals and antibiotics.

India’s local drug companies have long benefited from a relaxed patent regime.

History of patent law in India (up until the 1970s)

1856 The Act Vi Of 1856 On Protection Of Inventions Based On The British Patent Law Of

1852 Certain Exclusive Privileges Granted To Inventors Of New Manufacturers For A Period Of 14 Years.

1859 The Act Modified As Act Xv; Patent Monopolies Called Exclusive Privileges (Making. Selling And Using Inventions In India And Authorising Others To Do So For 14 Years From Date Of Filing Specification).

1872 The Patents & Designs Protection Act.

1883

The Protection Of Inventions Act.

1888

Consolidated As The Inventions & Designs Act.

1911

The Indian Patents & Designs Act.

1999

On March 26, 1999 Patents (Amendment) Act, (1999) Came Into Force From 01-01-1995.

1972

The Patents Act (Act 39 Of 1970) Came Into Force On 20th April 1972.

Source: Adapted from http://www.legalserviceindia.com/articles/patents_geographical.htm accessed 10th November 2004

In the past, India honoured patents on manufacturing processes but not patents on products, which allowed generic drug companies to ‘reverse engineer and manufacture drugs’ without paying royalties to the companies who own patents on those drugs (McNeil 2001).

The features of the 1970 Patents Act helped to promote India’s pharmaceutical industry, which specialises in generics. It has enabled considerable technological innovations and development of knowledge, with its provisions enabling the drug industry to grow at a rapid pace. (The Lancet, 2004)

The Indian Pharmaceutical industry is the pre-eminent sector in India, in terms of scientific and technological developments. India ranks among the top 15 drug manufacturing countries in the world. In 2004, the domestic drug industry met approximately ‘70% of India’s demand for bulk drugs, drug intermediates, chemicals, pharmaceutical formulations in the form of tablets, capsules and orals’ (Lancet 2004). India’s generic drug industry has enabled a huge number of people to afford essential drugs that would have otherwise been out of reach because of patent induced high prices and unavailability. Generic production therefore promoted self-sufficiency and assisted economic development.

“The Indian firm Cipla’s offer to MSF [Médecins sans frontiéres] to provide a cocktail of antiretrovirals for less than 0 a year (compared to the big boys’ ,000) resounded like a thunderbolt. Suddenly, the emergence in the South of very low cost generics producers seems credible” .

4. IMPACTS OF THE TRIPs AGREEMENT

This chapter discusses the impacts of the TRIPs agreement (January 2005) on India’s pharmaceutical industry. It starts by mentioning the pressure and reasoning behind India’s decision to comply with TRIPs, and then examines the positive and negative aspects of the agreement, which might emerge in the next few years.

India amended the law governing patents i.e. Patents Act, 1970 by Patent (Amendment) Act, 2002, on 20th May 2003.

The main features of Patent Act, 2002, were:

? Enlargement of non-patentable inventions

? Twenty year patent term for all patents

? Burden of proof on defendant in case of infringement when a patent is for the process of producing a new product

? Making importation a right of a patentee

This Act prepared India for full TRIPs compliance, and currently, India is adapting to the changes to the pharmaceutical industry under the TRIPs Agreement, which came into force on January 1st 2005.

Indian companies have now lost the opportunity to develop processes for patent protected drugs. This could allow multinational companies to establish a monopoly over the Indian drug market, unless Indian pharmaceutical companies can compete.

Pressure to comply with TRIPs

There was pressure for India to meet TRIPs requirements because India would have otherwise been disciplined by the WTO, and ‘India’s market access rights would have been jeopardised’ along with other benefits (Lancet 2004).

There was intense lobbying, predominantly by the United States pharmaceutical industry, to impose the TRIPs agreement. PhMRA claimed that the US pharmaceutical industry loses US0 million annually only through a lack of patent protection on drugs in India . The GlaxoSmithKlein CEO Jean-Pierre Garnier described the Indian pharmaceutical industry as price-undercutting “pirates”, and said the company “is not doing this to get a Nobel Prize.”

In response, Hamied, on behalf of the Indian pharmaceutical firm CIPLA, said “Indeed, we are a commercial company. But I market 400 products in India. If I don’t make money on a half-dozen of them, it’s no big deal. I don’t make any money on the cancer drugs we sell or drugs for thalassemia, a blood disorder that’s common in India. We sell these drugs virtually at cost because I don’t want to make money off these diseases which cause the whole fabric of society to crumble. India alone will have 35 million HIV cases by 2005, and it’s something we can’t afford.” (Lindsey 2001)

4.1 Main advantages

On the one hand, TRIPs could promote more research and development and stimulate competition to produce new drugs. On the other hand, India will lose its ability to generically produce essential drugs for its majority poor population.

Generic drug production in India has meant that research and development of new drugs has taken a back seat. Indian companies are ‘getting actively engaged in research and development of their own molecules/pharmaceutical products and processes . The Indian government is providing a range of tax concessions designed to encourage research and development, including a 10-year tax holiday on income arising from research and development. (Lancet 2004)

Thus, TRIPs is increasing investment in the research and development of new drugs. It promotes economic growth of the Indian drug industry, because companies now have patent induced control over the price and availability of new drugs. India already has more pharmaceutical products approved by the United States Food and Drug Administration (FDA) than any foreign country, which is helping the industry to obtain and enforce patents. The Indian pharmaceutical industry will be able to increase its contribution to drug discovery and development, which, given the cost-effectiveness of research and development in India, can only increase. (BJU 2003)

‘TRIPs will cement India’s position as a global pharmaceutical outsourcing hub and offshore location for research and development and other support services including strategic services in patenting and related matters.’ India is also becoming an attractive location for the outsourcing of patent drafting . In addition to these benefits to the industry as a whole, TRIPs has also imposed higher quality standards for drugs and processing.

Proponents of TRIPs argue that patent induced privatisation of the industry will lead to growth of the domestic industry that will increase the availability of all biotechnology products to poor people i.e. diffusion. However, as mentioned before, patents can reduce the availability of new essential drugs by restricting short term diffusion. Thus, although TRIPs may encourage more research and development of drugs, these drugs will be less available to poorer people who cannot afford them at times when they need them most.

However, there are counter-arguments that TRIPs will not make new drugs unaffordable. For example, Shantha Biotech, which was first to launch the indigenously developed hepatitis-B vaccine in the country in 1997, has secured the World Health Organisation (WHO) certification for its product “Shanvac B” (now marketed at “Hepashield”). Shantha is the only company in India to get this certification for the hepatitis-B vaccine, and it is being provided at a quarter the price of the previously imported vaccine (Jayaraman 2001).

However, despite greater availability of a few specific drugs, linked to some Indian companies obtaining licenses, the price of new drugs over the next few years is likely to be relatively high in terms of what the population is used to and can afford.

4.2 Main Disadvantages

Under TRIPs, there will be more consolidation in the pharmaceutical industry, as larger companies are more capable of using patents to secure higher profits. Linked to economies of scale, these companies will be able to exploit the patent system to out-compete other companies. Multinationals such as GlaxoSmithKline, which already operate in India, will have a particular advantage. Smaller companies will be less capable of buying into the strict patent system. Merely securing a patent from America’s patent office costs at least 00. Defending it in court can cost millions (Economist 2002).

Although TRIPs does not patent old drugs already on the market, there is still a backlog of products waiting for grant of product patents, some which may already be on the market, as product claim applications have been filed since January 1 1995. Unless Indian companies have stopped manufacturing such drugs completely, a large number of litigation and infringement suits will ensue .

TRIPs restricts India’s generic industry and longer patents provide additional incentive for foreign investment in India. This could actually pose a threat to India’s pharmaceutical companies. At an international level, Indian companies’ advantage in cheap vaccines for hepatitis or rabies may be eroded by potential development of cocktail vaccines that promise delivery of multiple vaccines in a single shot (Jayaraman 2003). Although TRIPs encourages growth of the industry and creates some large winners, it creates many losers.

Since the 1970s, India’s poor population has benefited from a range of drugs available at relatively low prices. The industry is efficient at making generic varieties and has a number of different companies able to produce such drugs, which means that new drugs on the market can be imitated both quickly and easily. This provides a means of sharing the benefits of technological advancement in developed countries with developing countries, usually isolated by a gap in technology. According to some reports, India is home to the fastest growing rate of new infections in the world (Hankins 2003). Without the benefits of generic drug production, the population of India could suddenly be faced with a health crisis.

According to a recent Times of India report; the price of cancer drug Gleevac has risen from to Indian Rs120, 000 (,590) from its price just a few months ago of Indian Rs4000 (.35) – 30 times more, because of TRIPs .

4.3 The Doha Agreement and Compulsory Licensing

TRIPs has a clause that allows governments to override patents and provide essential drugs to the poor in some circumstances. Working with Non Government Organisations (NGOs), Brazil and a group of African countries pressured policymakers to revise TRIPs. The meeting in Doha, November 2001, between the world’s trade ministers attempting to organise a new round of trade negotiations (Health Affairs 2004), led to the Doha “Declaration on the TRIPS Agreement and Public Health.” This declaration affirmed that TRIPS “should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.”

‘It affirmed the right of nations to use the exceptions of TRIPS, such as the compulsory licensing provision, to meet public health concerns, specifically stating that “public health crises, including those related to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency” and thus facilitate the right to use compulsory licensing’ (World Trade Organisation Declaration 2001).

‘Governments can issue compulsory licenses to allow other companies to make a patented product or use a patented process under licence without the consent of the patent owner, but only under certain conditions aimed at safeguarding the legitimate interests of the patent holder’ . For example, the Supreme Court of India may interfere to justify the dispensation of drugs at an affordable price on the grounds of concern for public suffering. They can grant a compulsory license for companies to produce a generic drug. If required, the government may also fix the price of these drugs as well as the royalties to be paid to the inventor for the remaining term of patent .

A further 30 August 2003 Amendment to the Doha Agreement enables governments to let their pharmaceuticals generically produce drugs for other countries, as well as their own people, in times of ‘acute suffering.’ Previously, Article 31(f) of the TRIPS Agreement stated that products made under compulsory licensing must be “predominantly for the supply of the domestic market”. (WTO Press Release 2003) This applied directly to countries that could manufacture drugs, limiting the amount they could export. It will now be possible for countries to import cheap generic drugs in times of ‘acute suffering’.

This was regarded as a victory by the developing world and as a defeat by the research-based drug industry.

However, there are serious questions as to whether compulsory licensing can even work. ‘No generic medicines have been manufactured this way in the past decade, treating no patients in any country worldwide’ (Attaran 2003). ‘Threats of compulsory licensing might be useful when rattling sabres with drug companies to lower medicine prices, but only a single (and unusually powerful) developing country, Brazil, has ever succeeded in doing so. As such, compulsory licensing or the threat of it has seldom had any practical effect for public health’ (Attaran 2004).

Nevertheless, the pharmaceutical industry in developed countries has objected, with the United States leading the objections. ‘America’s drug industry has fought tooth and nail to impose the narrowest possible interpretation of the Doha declaration, and wants to restrict the deal to drugs to combat HIV/Aids, malaria, TB and a shortlist of other diseases “unique to Africa” .’ This means that the industry is against the use of compulsory licencing, and only prepared to accept its use in Africa, which is very unethical when most developing countries do not have sufficient access to essential drugs. It highlights the ruthlessness of paharnceutical companies, in terms of seeking maximum profit even at the expense of the world’s health.

Compulsory licensing and the amendments to TRIPs are positive in respect to health care in developing countries. The changes suggest that governments do respond to pressure and there has already been some admission on their part that TRIPs could be revised under a more ethical framework. However, even with these amendments, TRIPs does not tackle the root problems of unequal power relations between developed and developing countries, which give rise to the unequal access to pharmaceutical biotechnology.

5. CONCLUSION

This chapter argues in favour of alternatives to TRIPs. It starts by summarising the benefit of increased public funding in research and development. It shows the close ties between science, business and government and goes on to explores wider policies, highlighting the ways that the scientific community can promote more ethical drug policy.

Public funding

If a larger proportion of research and development of new drugs was publicly funded, then this would encourage more investment into the development of essential drugs, which are needed in developing countries.

Data submitted to the Joint Economic Committee of Congress by the National Bureau of Economic Research reveals that public research, not private, led to 15 of the 21 most essential drugs introduced between 1965 and 1992, and other studies in the 1990s suggest that only a minority of important drug discoveries in recent years (estimates range from 17% to 40%) were the result of commercial research (O’Leary 2002). This shows that public funding is paramount to the production of essential drugs, and therefore to health in developing countries. The combined effect of shortening patents and increasing public funding in the pharmaceutical industry would ensure that not only are more essential rugs produced, but that they also reach those who need them.

The next section shows that scientists need to devote more attention to the unethical nature of drug policy and voice concerns to the public. This involves deconstructing a scientific agenda from the economic agenda of government and big business.

Governments, science and big business

Scientists ideally work to discover “truth” and gather knowledge to help people. Research and development, however, tends to be profit-driven, and there are conflicts between seeking scientific advancement and helping people, because helping people is not always profitable. Government policy supports the pharmaceutical industry, as strict patents favour the expansion if the industry and economic growth. Although business and governments are therefore dependent on scientists to design new drugs and technology, their common agenda allows them to exert political and economic control over science. Any social objective to deliver essential drugs to the poor is lost in this agenda. Scientific search for ‘truth’ therefore becomes a quest for profit, because of the vested interests of government and business.

The United States Office of Management and Budget reported that academia, in addition to federal funding, receives millions of dollars for research from donors and the private industry.

“Bioethicists at the University of Toronto take funding from GlaxoSmithKline, Pfizer and Merck to write editorials on bringing biotechnology to the developing world . . . Bioethicists at the University of Pennsylvania take money from Pfizer to write an article explaining why physicians should not accept gifts from companies like Pfizer. (Engler 2004) This shows the irony whereby large companies control information which should criticise their activities.

In the United States, even federal money comes with strings attached. Federally funded experiments and research are subject to massive amounts of bureaucratic regulation and oversight. Members of academia are now increasingly involved in the private sector. ‘This means that, even in basic research, funding is not free from profit motives or federal regulation, and the research is not necessarily a pure drive for more knowledge .’ Thus, it is hard to separate science from the profit motives of business and politics, which share a common agenda. Scientific information can be biased because it is conditioned by this agenda.

‘Today the most powerful players outside government are private corporations. They contribute financially to political parties in the US, Europe and elsewhere and a neo-liberal trade agenda has become the mantra of virtually all elected political parties. The price governments have to pay for this support is to ensure that their electoral platform corresponds quite closely to the agenda of big business.’ (Shutt 2001)

It is unfortunate that science, politics and business are so intertwined that it is difficult for the benefits of biotechnology and knowledge to jump the political and economic hurdles to reach developing countries.

It means that scientists need to be more vigilant about the type of drugs they help to produce, and what they endorse. Moreover, the scientific community need to play a more active role in raising awareness about pharmaceutical issues, so that people become more informed and capable of working with other groups, such as NGOs and members of the scientific community, to press governments for change. Scientists and the public can apply pressure to regulate the corporate sector, by imposing corporate social standards in the trade of drugs, and deconstruct those pressures from big business that controls science and information.

Public mistrust

Governments have control over science. They manipulate the science often finding a balance between where public support lies and where the money lies. This has resulted in public mistrust and scepticism in science. In the UK, for example, the public was informed by government that BSE could not be transmitted from cattle to humans, and the government promoted British beef and the industry for around ten years, before it emerged that there was a human form of the disease, variant CJD. Mistrust and scepticism was the result.

Scientific ignorance can also weaken the ties between science and the public. People may ignore the science because it is viewed as obscuring a larger picture (Michael, 1996). Science can be difficult to understand and, as mentioned, communication through the media reflects the agenda of business and government. If people do not trust the scientific media or understand the science of issues, their uncertainty can be compounded by a general mistrust of science and the scientific community. It is also important to consider that people also have different views on issues, which highlights the need for better communication and debate. New abortion procedures to people who are already pro-life are simply ‘more efficient ways to kill unborn babies,’ whereas to pro-choice advocates they are safer, less intrusive ways of protecting the choices and health of mothers .

People need to feel that a scientific organisation has no vested interests. This is why independent organisations for public scientific awareness and education are important to build up this trust. In Britain, this includes COPUS (Committee on Public Understanding of Science) run by the Royal Society. There is also the Wellcome Trust, which informs the public on science policy and practice (as well as contributing to researching social implications of sciences) “The culture of science needs a sea-change, in favour of open and positive communication with the media.’ If these independent scientific institutions, collaborating with NGOs and the scientific community, can succeed in informing and educating people, ‘it will pay for itself many times over in renewed public trust’. (UK Select Committee on Science and Technology 2000)

Agreeing with this line of thinking, if independent scientific organisations can give more attention to health problems in developing countries, then they can raise public awareness about these issues. The potential to change policy rests on a more informed public.

Individual scientists and the scientific community, collaborating with independent organisations, can debate ethical issues and highlight the importance of improving health in developing countries by increasing the availability of essential drugs. “Some of the favourite topics of bioethicists seem trivial compared with the important health issues facing people in the world’s poor countries and in impoverished regions in rich countries” (BMJ 2004). “The risk of dying from maternal causes in sub Saharan Africa is 1 in 16. In Western Europe it is 1 in 4000.” Bioethicists could focus their attention on the morality of a world system that allows “500 000 girls and women [to] die every year – 99% in developing countries – from preventable conditions and injuries related to pregnancy and childbirth.” (Lancet 2004)

It is especially important to make younger people more aware of the issues pertaining to the use of strict patents, in order to produce an informed public in the long term. Thus, there needs to be more attention to such issues in colleges and universities, as part of a curriculum, then younger people could debate for themselves the fairness of TRIPs. Again, a more informed public would be less likely to accept the ‘unfair’ policies enforced by their governments.

Therefore, policy must change. After all, it is the wider policies that enable corporations to exploit poorer people, who cannot afford to buy into technology. Roy Vagelos, the former head of Merck, claims that “‘A corporation with stockholders can’t stoke up a laboratory that will focus on Third World diseases, because it will go broke’ … ‘That’s a social problem, and industry shouldn’t be expected to solve it .’ Although biased from an industry viewpoint, he does make the point that companies are by definition profit motivated and that giving companies greater freedom is not in the best interests of health, especially poorer people.

Historical policy context

‘One cannot separate economics, political science, and history. Politics is the control of the economy. History, when accurately and fully recorded, is that story.’ (Smith, 1994). There are wider policies that need to be considered. Patents are a form of imperialism.

In the nineteenth and twentieth centuries rich, powerful states, including Britain and other European countries, exploited third world colonies. Richer states exploited the natural resources and workforce of the colony, and efficient supply chains were constructed for this purpose, based on unequal power relations. Although developing countries gained economic dependence in the 1960s and early 1970s, an economic dependence continued. Developed countries lent large sums of money to developing countries, and these debts became unpayable due to the rise in interest rates. Developing countries, instead of investing in health, still have to repay these debts, and they have become economically dependent on the companies and governments of developed countries, who control trade policy.

Thus, based on a historical trade policy context, governments in developed countries have the responsibility to help developing countries supply drugs to their populations.

‘Enormous agricultural subsidies (0 billion) in developed countries deny the agrarian populations of poor countries the opportunity to export products and accumulate wealth’ (OECD, Paris 2002). The subsidies alone are roughly equal to the entire gross domestic product (GDP) of sub-Saharan Africa. ‘Redirecting just 1 percent of this government spending to global health would more than double the foreign aid spent to control HIV/AIDS, malaria, and tuberculosis combined.’

President Yoweri Museveni of Uganda opines that giving priority to medicine patents in trade negotiations has been a “red herring” and that “if there were no agricultural subsidies…we [Africans] would earn enough money to buy all the drugs we want” (Wall Street Journal Editorial 2003). Although I think that reducing agricultural subsidies is just one element of improving pharmaceutical infrastructure in developing countries, he makes a valid point that improving the distribution of drugs is linked to redistributing wealth between countries.

Kanji et al (1992) take this further to point out that a country’s pharmaceutical and health policy cannot be isolated from its general development startegy. November et al 1982 elaborates by stating that ‘dependence on products [drugs] and the agents and institutions which make them available, fosters the notion that the solution to illness resides in the purchase and consumption of medications rather than improvements in living condtions’ (November et al 1981).

I agree with this line of reasoning that links the unavailability of essential drugs in developing countries to wider policies, and highlights the need for more sustainable development that takes into account the vulnerability of the poor by imposing strict social criteria in drug policy and trade, rather than strict patents (economic criteria). It should be emphasised that shortening the time length of patents is one important factor among many that could improve the avilability of essential drugs and all round healthcare in developing countries.

Melrose, 1982, says that ‘companies should keep to their declared obligation of making sure that drugs “have full regard to the needs of public health” and demonstrate special social responsibility in poor countries by not advertising non-essential multivitamin tonics, cough and cold preparations and expensive and irrational combination drugs (Melrose 1982).’ Although I agree that corporations need to behave more responsibly, this should be a legal prerequisite rather than an ‘obligation.’

Ironically, there is great potential and ability of the large pharmaceutical firms, which have been so criticised in this text, to develop more essential drugs for the poor. The private sector has a great deal of knowledge and capital, which can be used to produce new essential and non-essential drugs. Thus, although public funding would help to give priority to essential drugs, the private sector should still contribute significantly. This is especially the case in the foreseeable future because the private sector is largely responsible for the production of all new drugs. ‘If Pfizer, Merck, Glaxo-Wellcome, and other pharmaceutical companies do not develop drugs that plague developing nations then …there is a real danger that people in developing nations will become therapeutic orphans’ if the pharmaceutical companies lack the proper incentives to develop drugs for the developing world’ (Reich 1979-1981).

Thus, the final part of the conclusion looks at ways of regulating the corporate sector.

Regulating the corporate sector

Governments can regulate the pharmaceutical industry in two broad ways, either by direct control, usually by making legal requirements, or by creating incentives. A mixture of the two strategies can be effective.

Control involves regulating and monitoring biotechnology companies and pharmaceuticals through the creation of legal requirements. For example, when these organisations develop drugs/ vaccines, governments can mandate them to comply with research and manufacturing standards to ensure products are safe and efficacious . Governments can control drug prices furthermore because they often have authority over the granting and use of patents. For example, in the US, the government has the right to license drugs to other companies if the patentee does not make it available to the public on reasonable price and terms. Such a right is currently focused on drugs that have been developed with public support . It needs to extend to drugs developed with private support.

Although laws are paramount in regulating corporate conduct, there is the issue that corporations have no moral obligations over and above the requirement to comply with the law (Friedman 1970). Governments can, in this regard, create further incentives for these organisations to engage in developing drugs/ vaccines that benefit populations in developing countries. For example, it could create subsidies or offer grants for research in certain areas. The Orphan Drug Act, introduced in the US in 1983, creates tax and marketing incentives for those companies that engage in creating drugs for rare diseases. Also, governments could commit to purchasing future critical drugs/ vaccines in order to minimise the ‘private entity’s financial risk’ .

Ideally, TRIPs should be replaced by policy which curtails the power and influence of the private sector, by shortening the time length of patents, allowing generic production in developing countries, and at the same time increasing public funding of research and development.

In summary, making more ‘ethical’ drug policy is dependent on:

? International policies

- removing TRIPs, shortening the length of patents; allowing developing countries to generically produce essential drugs.

- subsidising research and development of essential drugs.

- regulating the corporate sector: ensuring that essential drugs are reasonable priced; ‘a price that allows the company to earn its money but also promotes accessibility and equity’ (Brody 1996) & (Spinello 1992).

? National policies

- providing funding and technical support for NGOs who raise awareness of the issues surrounding the use of strict patents in the pharm,aceutical industry.

- Promoting education in schools; collabortaing with independent scientific organisations to provide information publicly, through the media.

- Setting an example by increasing public funding in research and development; prioritising investments in essential drug production; greater transparency; governments more accountable to the public than companies.

- Campaigning for fairer drug policies at the international level

? Education and public awareness

- Informed people in developed countries, able to raise issues pertaining to the use of strict patents and resist ‘unfair’ policies.

? The role of the scientific community

- a scientific community that focuses more on third world issues and health problems, and raises awareness about the underlying policies that cause an imbalance in wealth and health.

- Independent scientific organisations that can communicate information to the public and collaborate with scientists and NGOs, and raise concerns with business and government.

- campaigning for ‘truth’ and sharing of knowledge, as well as more regulation of the corporate sector, and governments who are more accountable to the public.

This paper highlights the interconnectedness of social, economic and political factors which can improve the availability of essential drugs in developing countries.

To end on a more positive note, pharmaceutical companies have created life-saving drugs which have helped to save millions of lives, but these drugs have tremendous potential to save many more lives and alleviate suffering by helping to curb the incidence of various infectious diseases, which cripple the social and economic fabric of developing countries. The paper also highlights the importance of better understanding the impacts of TRIPs in developed countries, so that governments are pressed to change policies at the national and international level. The role of the scientific community is critical, in terms of having more say and control over drug policy, and helping to increase public awareness about drug policy. Ultimately, a concerted effort between the scientific community, public and NGOs can resist ‘unfair’ drug policy and some of the exploitative practices of pharmaceutical companies.

7. REFERENCES

Books/Journals

Attaran, A. (2003) Assessing and Answering Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: The Case for Greater Flexibility and a Non-Justifiability Solution. Emory International Law Review 17, no. 2 (2003): 743–780.

Benatar, S. (2000) Avoiding Exploitation in Clinical Research. Cambridge Quarterly of Healthcare Ethics 2000; 9: 562-65

BJU (2003) Fitzpatrick (Ed) International Volume 92 No

Biotech research holds a great deal of promise for future innovation in the treatment of previously untreatable diseases. But how long does it take for a biotech therapy to come to market? The answer may surprise you. Due to the rigorous review process all drugs must undergo in the United States to ensure safety, it isn’t uncommon for a 10-15 year time period to go by before a new therapy is approved. Join Dr. Targan as he walks us through the drug review process from its start at the FDA, to the final approval of innovative new therapies.

Launching a new product is undoubtedly one of the most stressful and difficult times for any entrepreneur. Whether it’s your first product, your fiftieth, or your hundredth, knowing just how the market will react is something that you can never do through intuition alone. Although the most popular and successful entrepreneurs are said to have the ‘personal touch’ that can predict a product’s success, they’re more than often wired up to the hard data when making any major decisions. While focus groups and beta testers are often without of the financial means of many internet entrepreneurs and marketers, it’s easily possible to use the massive search traffic of Google as an effective replacement for traditional marketing test groups.

By running AdWords campaigns that are specifically targeted to your own market, you can gain some massive and valuable insights into your market’s performance, consumer preferences, and general price for any product. Simply put up a series of advertisements that test for several variables of your product, either price, name, and product description, and let the results speak for themselves. Whether you’re looking to sell 10 copies or 100, the information that an AdWords campaign can bring to you is priceless.

Need some guidelines? Here’s a simple example, using an eBook as a demo product:

You’re trying to market an eBook that you’ve written yourself. With five potential product names, 10 potential product descriptions, and no idea of the price, you need to gather as much information as quickly and cheaply as possible.

First, run five different Google AdWords campaigns, using the book’s potential titles in the ad text or headline. Everything else on the ads needs to stay the same, and there needs to be no mention of pricing or approximate costs. See which one performs the best, and then lose the others.

Then, run your ads with ten different product descriptions. The titles and headlines should be consistent and identical, with only the advertising copy changing. Find out which product description works the best for your audience, and lose the others.

Then, run the same tests over and over again, but this time to determine price point. Set ten different prices, and see which one continually leads to most people to both click on your advertisement and read through your product description and sales copy. At the end of the page, put a “name and email” form and collect details for potential customers.

By using this simple strategy, you’ve created a marketing database, an easy email list, and given yourself the opportunity to market to people directly once your product launches. Not only that, you’ve determined the best name, description, and price for your online product. Not bad for a little AdWords spending, and certainly more cost effective than the traditional methods of gathering market information.

The growth of the World Wide Web has been one of the major events in the second half of the 20th century. A big advantage of World Wide Web for businesses is the availability and quick access of information than ever before in the history of mankind. Businesses can access almost any kind of information from any corner of the globe just in few minutes that can aid decision-making. Information online has become a commodity available in many flavors.

Remarkably, there is an immense amount of information online that is not only accessible to all but can be created and shared by almost everybody. According to a claim by Google, there are around 8.1 billion documents online and are growing rapidly. A team of researchers from SIMS – University of California claims that the size of the information on the World Wide Web is 170 terabytes. Information of about 170 terabytes is equal to ten times of the information available in the Library of Congress. This new height of information availability and accessibility is influencing the dynamics of the global markets as well as regional businesses more or less equally.

Most of the data available online is in English as it is the most popular language online. More than 80% of home pages on the Web are in English, while the next greatest, German, has only 4.5% and Japanese 3.1%, according to englishenglish.com. Clearly, this means more information in English is available online than any other language.

The above statistics from various sources reiterates that the information available online is not only abundant but also growing rapidly at an exponential pace. This vast size of the information available never earlier in the history of mankind, sometimes becomes a challenge for the business researchers to find the reliable and credible information within it.

The major contributors of the information online that is useful for the businesses are market research companies, industry associations, related-industry web sites, competitor companies’ websites and government sources like www.bls.gov. Information from various sources from a variety of backgrounds can help online researchers to crosscheck and validate the data they are collecting for the research purpose. Information thus derived from the online secondary research is good enough to give insight into the research issue and help the businesses in well-informed decision making to the extent possible.

The increased efficiency of the information availability has significantly increased the level of information endowment on a variety of fields of marketing and business as a whole. The abundance of information available online that is instantly accessible at low or no cost has certainly created a great resource for secondary research for businesses.