Medical Knowledge

Introduction

The advent of 21st century marked the beginning of an age when the spread of knowledge and information had taken on unprecedented importance. With exponentially increasing effort in research, breakthroughs in medical research have benefited tens of billions of world population.

However, not all the people in the world have enjoyed the fruits of intensive medical research to the same extent. Citizens of impoverished developing countries who are in urgent need of medical assistance are often denied access to new drugs and medical knowledge because of their limited wealth.

The distribution of diseases and the distribution of medical knowledge are also imbalanced. Wealthy and developed countries are controlling new medical knowledge because large amount of funding is poured into medical sector to support research and development of new drugs. However, the large populations that are suffering from prevalent diseases are living in poor tropical countries with billions of people living on less than one dollar a day. They are therefore denied access to drugs developed by rich countries simply because they cannot afford.

Each year, millions of people in developing countries lose their lives due to diseases, which could have been cured if they had access to affordable drugs. The healthy life expectancy (HALE) in Sub-Sahara is below 50 years (Figure 3.1). It could be largely improved with provision of access to cheap drugs.

 

Figure 3.1 Life expectancy at birth
source: www.maps.com/ref_map.aspx?pid=12869

On one side of the world, the pharmaceuticalindustry is enjoying enormous profits through selling drugs. On the other side of the world, impoverished people are struggling on death line due to lack of essential medicines. What caused the gap? How do we bridge it?

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Intellectual Property Rights (IPR) and Patent

According to the website of the World Trade Organisation (WTO), intellectual property rights are defined as follow:

“Intellectual property rights are the rights given to persons over the creations of their minds. They usually give the creator an exclusive right over the use of his/her creation for a certain period of time.”

Intellectual property rights fall into two categories:

World Health Organisation (WHO) defines a patent as:

“A patent is a title, granted by the public authorities, conferring a temporary monopoly for the exploitation of an invention on the person who reveals it, furnishes a sufficiently clear and full description of it and claims this monopoly.”

In health sector, the significance of the presence of IPR and patents is that, by allowing the drug companies to charge more than the marginal cost of the products, intellectual property rights and patents help the drug companies,research institutes and medical personnel recoup their investment in developing the drugs. Furthermore, IPR and patents also motivate drug companies and medical personnel to devote to medical research and development because patent-holder can then lawfully monopolize the market for a certain period of time and enjoy the profit without competition.

However, IPR and patents have also created many problems, with one of the most controvertible one being denying the access of poor developing countries to cheap drugs. The strict IPR protection and high prices of drugs in developed countries often make it impossible for people in poor developing countries to afford medicine and vaccines that are in urgent need.One of the most striking examples would be that of Sub-Saharan Africa.
Anti-retroviral (ARVs) drugs are one of the most essential drugs to treat HIV/AIDS. The patent-protected ARVs cost about US$10,000 per patient per year. However, according to World Development Indicator 2007 issued by World Bank, the average Gross Domestic Product (GDP) per capita in Sub-Saharan countries is only US$842, far from being able to afford ARVs. Most importantly, Sub-Saharan Africa is the region where HIV/AIDS is most prevalent in the world. According to HDR Regional Fact Sheet (2005), “25 million people are infected with HIV in Sub-Saharan Africa, out of a global total of 38 million. Fewer than 4% of people in need of antiretroviral treatment for HIV are receiving drugs”.The problem is exacerbated by the lack of public health services especially health insurance schemes in those countries that could have helped the patients cover medical expenses.
The prevalence map of HIV is shown below with the darkest colour indicating highest percentage of population infected with HIV. (Figure 3.2)

Figure 3.2 HIV prevalence map
source: data.unaids.org/pub/GlobalReport/ 2006/2006GR-PrevalenceMap_en.pdf

 

In fact, after the time limit of a patent, the price of the drug can drop to lower than 10% of the patented price due to market competition.

Another problem that patent system has created is the types of new drugs developed are often biased against poor tropical countries. For example, according to the statistics released byWHO, out of the 1,325 new medicines launched between 1975 and 1997, only 11 were specifically for tropical diseases.

Though developing countries consist of large populations, they are relatively small markets because of low buying ability. As a result, drug companies are not interested in developing new drugs to cure diseases affecting people in poorer parts of the world. Again, economic gain, the sole impetus behind research innovation, sees its limitation in alleviating the suffering of impoverished people.

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TRIPS and Doha Declaration

Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreementwas signed in year 1995 as part of WTO Agreement. It mandates that WTO members must implement patent protection, so as to protect intellectual property rights. Although certain exceptions were made in 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,” according to WTO, the flexibility was accused as being too restricted.

Prior to WTO’s agreement on patent protection, there was no patent protection in India. As S Vedaraman,then director of the Indian Patent Office who drafted India’s patent law of 1970,put:“ we are not against patents. And we are prepared to pay decent licence fees. But we in India cannot afford monopolies.' Absence of patents was one of the factors that drove India’s rising pharmaceutical industry because drug companies could sell generic version of patented drugs at a very low price, making their products marketable. Patients in India also greatly benefited from the cheap drugs as low prices led to greater accessibility.

However, after TRIPS was mandated, India’s pharmaceutical industry suffered great losses. Multinational drug companies re-dominated India’s drug market, marginalizing India’s own drug companies like Cipla, which were once very successful in local market. Patients in developing countries were denied access to cheap drugs, as they were unable to buy cheap generic version of patented drugs imported from India.

Six years after the signing of TRIPS, Doha Declaration was signed in year 2001at the Fourth Ministerial Conference in Qatar to address some of the problems apropos to heath sector. Doha Declaration focused on the “exceptions” under TRIPS, and clarified how the exceptions can serve to grant poor countries access to cheap drugs.

Doha Declaration is a groundbreaking treaty to give developing countries access to cheap drugs.
Some of the initiatives taken to alleviate the problems include:

Loosen patent protection
Differentiate the pricing of drugs
Regulation on drug companies
International medical aid

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Organisations:

CPTech (Consumer Project on Technology)

First International Summit for Access to Generic HIV Drugs

Global Treatment Access Campaign

Health Action International

Health GAP (Global Access Project)

Health GAP Campaign: Patents and Medicine

MSF Campaign for Access to Essential Medicines

Oxfam Cut the Cost Campaign

Treatment Action Campaign (South Africa)

WHO (World Health Organization) - Essential Medicines

References

Oxfam America

http://www.oxfamamerica.org/whatwedo/issues_we_work_on/trade/news_publications/trips/art5387.html

http://www.oxfamamerica.org/whatwedo/issues_we_work_on/trade/news_publications/trips/art5389.html
http://www.oxfamamerica.org/newsandpublications/publications/briefing_papers/art793.html/OA-Formula_for_Fairness.pdf

http://www.oxfamamerica.org/whatwedo/issues_we_work_on/trade/news_publications/trips/art5386.html
http://www.oxfamamerica.org/whatwedo/issues_we_work_on/trade/news_publications/trips/art5391.html

http://www.oxfamamerica.org/whatwedo/issues_we_work_on/trade/news_publications/trips/art5390.html
BBC News

http://news.bbc.co.uk/2/hi/health/3201219.stm

WTO

http://www.wto.org/english/tratop_e/trips_e/tripsfactsheet_pharma_2006_e.pdf
http://www.wto.org/english/tratop_e/trips_e/factsheet_pharm01_e.htm#notapermit
http://www.wto.org/english/tratop_e/dispu_e/dispu_e.htm
http://www.wto.org/english/tratop_e/trips_e/pharma_ato186_e.htm
http://www.wto.org/english/tratop_e/trips_e/pharmpatent_e.htm
http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_e.htm#trips
http://www.wto.org/english/tratop_e/trips_e/intel5_e.htm
http://www.wto.org/english/docs_e/legal_e/final_e.htm
http://www.wto.org/english/tratop_e/trips_e/intel1_e.htm

WHO

http://www.who.int/topics/intellectual_property/en/
http://www.who.int/intellectualproperty/en/
http://www.who.int/trade/glossary/story071/en/
http://www.who.int/trade/glossary/story017/en/
http://www.searo.who.int/LinkFiles/Health_Ministers_Meeting_WP5-Access_to_Medicines_and_Vaccines.pdf
http://www.who.int/ethics/en/background-macklin.pdf

Third World Network

http://www.twnside.org.sg/title/foster.htm
http://www.twnside.org.sg/title/twr120h.htm
http://www.twnside.org.sg/title/twr120e.htm
http://www.twnside.org.sg/title/mk2.htm

The World Revolution

http://www.worldrevolution.org/guidepage/accesstomedicines/intro
http://www.worldrevolution.org/guidepage/accesstomedicines/overview
http://www.worldrevolution.org/guidepage/accesstomedicines/website

BMJ

http://www.bmj.com/cgi/content/full/330/7493/692

2006 global report-a global overview of HIV infection

http://data.unaids.org/pub/GlobalReport/ 2006/2006GR-PrevalenceMap_en.pdf

World development indicator 2007

http://web.worldbank.org/WBSITE/EXTERNAL/DATASTATISTICS/0,,contentMDK:21298138~pagePK:64133150~piPK:64133175~theSitePK:239419,00.html
Others

http://www.igtn.org/pdfs/27_TRIPSPublicHealth.pdf

http://www.guardian.co.uk/society/2006/nov/14/internationalaidanddevelopment.medicineandhealth

http://www.ke.undp.org/ HDR 2005 -- Sub-Saharan Africa fact sheet.doc

http://www.maps.com/ref_map.aspx?pid=12869

 

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