India S Adoption of TRIPS-Consistent Legislation Covering Pharmaceuticals Will Not
13 November 2006
PHYSICIANS FOR SOCIAL JUSTICE, PSJ, NIGERIA
ROOM 1 & 2 RURAL HOSPITAL SAHO- RAMI,
P.O. BOX 18KONTAGORA, NIGER STATE, NIGERIA.
Re:Comments on the ICCR report on “benchmarking AIDS”.
My name is Chukwumuanya Igboekwu. I am a physician and currently serve as the Health Program Associate of Physicians for Social Justice, PSJ, a non profit organizationbased in Nigeria.
I have had the opportunity to read the InterfaithCenter on Corporate Responsibility (ICCR)“Benchmarking AIDS” report and some of the responses to it by the pharmaceutical industry. From reading these two sources, it is clear that the pharmaceutical industry finds it very easy to blame the inability of 40 million HIV/AIDS-positive individuals to receive sufficient medical treatment squarely on the dilapidated and inefficient health systems in Africa and most developing countries. It is very interesting to see how the industry is so quick and so ready to cite the statement of Kevin De Kock, the Head of HIV at the World Health Organization (WHO), who said in July 2006, "If you work in these countries it is very obvious, very quickly, that the elephant in the room is not the current price of drugs. The real obstacle is the fragility of the health systems, particularly in Africa.”From these responses, one can see that pharmaceutical companies have developed a strategic cover to hide their own contributions to this lack of access and lay claim to other reasons as to why the pharmaceutical industry, specifically under patent protection, is not part of the problem. Instead of constructively examining the legitimate concerns raised through the report, they prefer to focus instead on the weak healthcare systems as if that is the only cause for the failure of life-saving treatment to reach millions of HIV/AIDS positive people in developing countries. While the arguments of the multi billion dollar pharmaceutical companies make a lot of sense to an inexperiencedmind, it is not in any way reflective of the actual realities for someone working in a poor resource rural setting like myself.
As a physician residing and working in one of Nigeria’s most remote rural regions in northern Nigeria, I know that the claim of the pharmaceutical industry, that poor infrastructure is largely responsible for lack of access to medicines, is unfounded. I know that even with the limited human and material resources at our disposal in rural hospitals, we still have the capacity to run an effective anti-retroviral treatment program. As a matter of fact, AIDS treatment programs can successfully be integrated into the Primary Health Care system of most developing countries. For example, to run a Mother-to-Child Transmission Prevention program (PMTCT) requires no state-of-the -artmedical facilities; what is most needed are knowledgeable people who can pass the proper information on to others. Even a trained midwife can successfully offer such services in the most resource constrained rural setting with very minimal health infrastructure.
Humanitarian organizations, such as Doctors without Borders (MSF) and Partners in Health (PIH), have been able to demonstrate beyond reasonable doubtthat it is possible to deliver high quality anti-retroviral therapy (ART) even in the most resource constrained settings; these organizations have attained success in both rural South Africa and Haiti respectively.
MSF relies heavily on cheaper generic ARVs for their AIDS treatment programs. MSF is currently able to provide over 60,000 HIV/AIDS patients with anti-retroviral (ARVs)drugs because generic competition drastically lowered the prices of first-line medicines. However, as resistance tofirst-line medicines gradually increases, second-line medicines will become increasingly necessary and MSF will face difficulty in continuing to effectively provide HIV/AIDS patients with the necessary medicines.Due to strengthened patents brought about by the TradeRelated Intellectual Property agreement (TRIPS) of the World Trade Organization, it is becoming even moredifficult to have access to these second-line medicines. These newer drugs cost about four to ten times more than first-line treatments, even at discounted prices.
When it comes to accessing affordable antiretroviral medicines, the bulk of the burden lies at the doorstep of the pharmaceutical industry. If patentsare not the issue, then why did 39 pharmaceutical companies file law suit against South Africa when it attempted to expand antiretroviral treatment for her HIV positive citizens?The case of South Africa provides an example of corporate bullying, wherepoor countries who seek to use TRIPS-compliant provisions, such as parallel importing, in the interest of public health aresued into inefficacy.This is a problem that is evident each day; to point out a recent case, Novartis, the Swiss based pharmaceutical company filed a law suit challengingIndia’s new patent law at a Chennai High Court. Knowing full well that India supplies the bulk of generic drugsto most developing countries, Novartis aims to severe the pharmaceutical supply lifeline of these nations.
If patentsare not the issue, then why are the brand name pharmaceutical companies becoming even more aggressive through championing the inclusion of “Data Exclusivity” clauses that will effectively extend their patent rights beyond the normal 20 years period?Data Exclusivity prevents national regulatory authorities fromrelying upon the originator’s drug test data to approve generic applications during a predetermined period of time. The application of Data Exclusivity has the potential to delay the entry of cheaper generics into the market. Also, it is unethical to replicate some testing of drugs on human subjects, (Judit Rius Sanjuan et al, Consumer project on technology).
Were it not for generic medicines, how many of the 6 million people whom the World Health Organization (WHO) classified as urgently needing ARVswould have access to treatment currently? Were it not for generics how couldWHO have made progress in the “3’ by 5’initiative,” aimed at scaling up ART treatment for people in poor countries.
Several countries have made much progress in providing necessary medical treatment for HIV/AIDS positive patient. These few countries, includingBrazil, have made significant progress in AIDS treatmentnot because their health systems are very advanced and efficient but because they found a way to circumvent the current unethical intellectual property law being championed by the World Trade Organization and the multi- billion dollar pharmaceutical industry. Brazil commenced free antiretroviral therapy for its citizens since 1996. This is possible because most of the AIDS medicines it started her treatment program with were not patented in Brazil and could therefore be produced as generics.
It is common knowledge that the WTO -TRIPS is a product of themost successful corporate lobbying campaigns in history.According to Oxfam GB, TRIPS represents the most nebulous, symbolic and ideological wishes of the world’s richest companies, and has succeeded in creating effective legal monopolies for large northern-based pharmaceutical companies. Edmund Pratt, the Chief Executive officer of Pfizer, the biggest US pharmaceutical company, was quoted at that time as boasting that “their (pharmaceutical industry) combined strength enabled them to establish a global private sector”–government network which laid the groundwork for what became TRIPS, (Oxfam GB, WTO Patent Rules and Access to medicines 2001).
The net effect of TRIPS is its success in effectively blocking the availability of cheaper generic medicines.As an illustration of this fact, Abbott, the US Chicago based pharmaceutical company, continues to drag its feet in filing for registration of its very potent anti-AIDS drug Kaletra, in most African countries. Kaletra is particularly suited for poor countries and rural areas because it does not require refrigeration to keep and is quite heat resistant. Yet Abbott continues to hold the patent which gives them a monopoly on the drug until a generic version is available, thereby effectively putting this vital drug out of the reach of millions of patients who desperately need second-line treatment option to prolong their lives.
In its response to the ICCR report, Pfizer still brought up the untenable argument that “strengthened intellectual property protection is crucial to creating incentives for pharmaceutical innovation.” There is, however, little evidence that the current intellectual property law creates incentives for the development of new drugs. The pharmaceutical industry often forgets that a substantial part of investment in Research and Developmentalso comes from public funding through research institutes and universities. Several drugs, including Stavudine, have been developed at YaleUniversity. Also an analysis of a small sample of pharmaceutical inventive activity before and after compulsory licensing showed that no uniform decline in scientific innovationoccurred, challenging the assumption that strengthened patent protection is necessary to foster the development of new drugs. Furthermore, current patent protections do not necessarily create financial incentives for the development of desperately needed drugs in poor countries. Recent statistics show that between 1975 and 1997, only 13 out of 1,223 new drugs introduced globally were specifically targeted toward diseases disproportionately affecting poor countries,(Michael Westerhaus et al, How Do Intellectual Property Law and International Trade Agreements Affect Access to Antiretroviral Therapy).
In the ICCR report, Novartis noted that the majority of current health problems in poor countries can be controlled through making available effective preventive and curative treatments at commodity prices. It went further to say that what is required, however, is investment in adequate training of health staff and efforts to upgrade obsolete facilities and overcome the chronic shortage of equipment and essential drugs. However, the company failed woefully to say how the chronic shortages of essential drugs are to be met. Obviously Novartis forgot the fact that its own actions were a key factor in meeting this recommendation. Novartis neglected to mention that the best way to meet this aspect of recommendation is not best metby filing a court case against a government (India) whose pharmaceutical industry has been playing a pivotal role in meeting the essential drug needs of poor countries. Novartis chose to not address this major issue but preferred to shift attention towards other less pressing issues.Also what exactly does Novartis mean by commodity prices? If my guess is right, I assume that the company does not see any need to lower the current market prices of drugs. Here again, Norvatis failed to take into consideration the pattern of health expenditure in most developing countries. Weneed to remind this company that prescription drug costs account for about 80% of household health spending in most developing countries. Thus by making families spend more of their income on medicines, pharmaceutical companies indirectly create more poverty.
The fact still remains that strengthening patent protection in developing countries will not change the basic market reality. The entire African markets for e.g. represents only a small fraction of the multinational pharmaceutical companys’ sales. It is also worthy of note to recall that many European countries, including Switzerland which is the home of many innovative pharmaceutical firms, refused the idea of pharmaceutical patent when their industries were at infancy stage. Switzerland and Italy introduced patents in 1977 and 1978 respectively, when their pharmaceutical industries had almost fully developed. So why are the rules changing now for developing countries? This is a clear case of double standard and equally touches at the core of human rights denial.
Articles 25 of the UDHR*, article 12 of ICESCR** and article 24 of CRC***, all affirmed the right of persons to the highest attainable standard of health irrespective of the race, ethnicity, gender or socioeconomic status.Access to medicines is a core component of the right to health and critical to the protection of the ‘right to life’ particularly in the context of endemic diseases such HIV/AIDS. The United Nations Human Rights committee in its general comment 6 and 14, and the 57 & 58 Commissions on Human Rights under resolution 2001/33 further confirmed this by calling on States and other relevant third parties such as the pharmaceutical industry to refrain from taking measures which will deny or limit equal access for all persons to pharmaceuticals used to treat pandemics such as HIV/AIDS. By blocking access to life-saving medicines for millions of people all over the world, pharmaceutical companies and the governments who support them are in gross violation of international human rights law.
The fact remains that most poor countries do not currently have the capacity for local production of these vital medicines. Eliminating barriers to universal access to affordable essential life-saving medicinesis one of the first key steps to a comprehensive strategy in the fight against pandemics such as HIV/AIDS.
As an organization the Physicians for Social Justice believes that the ‘right to health’ and the ‘right to life’ are fundamental human rights which must prevail over the narrow corporate interests of the multi-billion dollar pharmaceutical industry.
Enough of this blames game.Human rights cannot be traded.
UDHR*; Universal Declaration of Human Rights, ICESCR**; International Covenant on Economic Social and
Cultural Rights., CRC***; Convention on the Right of the Child.
Thank you,
Sincerely,
Dr. Chukwumuanya Igboekwu
Health Program Associate
Physicians for Social Justice, Nigeria