Geneva, Switzerland, 11/14/2006 - Oxfam’s Review of TRIPS, “Patents versus Patients: Five Years after the Doha Declaration” advances the false premise that TRIPS-related intellectual property rules remain a major barrier to access to medicines in developing countries.

A. IFPMA comments on the general thrust of the Oxfam report.

1) Access to medicines is not the major issue affecting health in the developing world. As the new Director General of the WHO, Margaret Chan said in her inaugural address: “Health systems are the tap root for better health. All the donated drugs in the world won’t do any good without an infrastructure for their delivery.” The missing infrastructure referred to includes hospitals, clinics, medical equipment and supplies and, of course, trained health care workers at all levels. A significant part of the major commitment by research-based pharmaceutical companies to partnership programs to improve health in LDCs is devoted to compensating for the lack of health care infrastructure in those countries.

2) Intellectual Property is not a major obstacle to access to needed medicines. Critical medicines are defined in the WHO’s List of Essential Medicines Lists . Very few of these are patented: 95% are not patented anywhere in the world, 99% are not patented in sub-Saharan Africa. Even many antiretrovirals (ARVs) for treating HIV/AIDS are now off-patent.

3) Where essential medicines are still under patent, such as some ARVs, but also new treatments for other conditions, the manufacturers make them available in developing countries at cost, below cost, or even for free. For example: the PMTCT Donations Program provides free test kits & ARVs to prevent mother-to-child transmission of HIV/AIDS in 69 developing countries. Major industry-backed access programs, such as Accelerating Access Initiative (AAI), work within the patent system to greatly improve access to needed medicines through preferential pricing or donation. In 2005, AAI reached 716,000 HIV/AIDS patients in developing countries. Also, research-based pharmaceutical companies have put in place voluntary licensing programs to help improve access in some markets (e.g. 1st line ARVs - voluntary licenses in India, Kenya & South Africa; 2nd line ARVs - voluntary licenses in Kenya and South Africa).

4) The availability of generic versions of complex, modern medicines does not equate to adequate access. For the sub-Saharan LDCs with the biggest health care challenges, compulsory licensing cannot therefore offer a real solution. This is not because the TRIPS agreement is flawed, or developed countries are blocking compulsory licensing, but because these countries concerned have total per-capita health care expenditures of around USD 10 / year, so being able to obtain new-generation second-line ARVs at a generic-level prices of several hundred dollars per patient per year is not exactly a panacea. Countries like Mozambique, Zambia and Zimbabwe have tried invoking compulsory licensing for ARVs, without achieving any significant increase in availability of ARVs. Prior to 2005, India did not respect foreign patents and its generic manufacturers were able to copy ARVs which were still under patent elsewhere. Yet actual access to ARVs in India was (and remains) on a par with sub-Saharan Africa.



5) For LDCs trying to source complex modern medicines, generics may not even be the cheapest source. As studies by Médecins sans Frontières (MsF) show, the price of generic ARVs in developing countries is often more expensive than that of branded products made available at preferential prices through various partnership programs (especially as generic prices generally do not include shipping).

B. IFPMA comments on recommendations made in the Oxfam report

1) Review the impact of the TRIPs agreement on affordability and availability of medicines in developing countries.

a. most pertinent section, paragraph 6, was only adopted in December 2005. Most WTO members have not yet ratified this, so calling for a review now is premature.

b. The solutions to fundamental health problems related primarily to poverty lie outside the IP field. This has been recognized in a range of major initiatives, enjoying the support of both developed and developing countries. These include the Initiatives like the Global Fund for HIV/AIDS, Malaria and TB, the GAVI Alliance, the International Finance Facility for Immunization and the prospective Advance Market Commitment concept for funding development of new vaccines for neglected diseases are recognition that only a significant combined effort by rich countries will have a really significant impact on improving health in the poorest ones.

2) Stop USA coercing developing countries into adopting “TRIPS Plus” intellectual property protections via FTAs/ Developing countries to “resist” “TRIPS Plus”/ Pharma companies to stop lobbying for strong IP rules

a. Both partners pursue bilateral FTAs in pursuit of mutual advantage. There is no obligation involved and FTAs are a way of advancing the pursuit of free trade benefits in the face a stalled Doha round of multilateral talks. If a country decides to enhance its IP protection as part of an overall trade package with another country, that is their sovereign right to do so.

b. Leading developing countries (such as China, South Korea, and others) have chosen to implement enhanced IP provisions called “TRIPS plus” and are developing their own domestic R&D-based pharma and biotech industries. In countrast, countries which have not done so (such as Argentina) have stagnating or shrinking industries.

c. The governments of some developing country partners of the USA in FTAs say clearly that such “TRIPS Plus” provisions are already in their national law (such as Moroccan provisions restricting parallel trade, which predate that country’s FTA with the USA.)

d. There is no reason for the research-based pharmaceutical industry to stop advocating constructive national policies which encourage innovation and promote improved public health through new, innovative pharmaceutical products.

e. It should be noted that provisions characterized as “TRIPS-Plus” in FTAs (such as data exclusivity, market linkage, secondary use patents, and countries deciding to not allow parallel trade) are actually within the basic TRIPS Agreement’s provisions.

3) G-8 countries to help developing countries use “flexibilities” of IP agreements

a. Actually, proposals from industrialized countries in the WIPO Development Agenda debate would promote WIPO assistance in strengthening national IP administration and regimes for the benefit of developing countries.

b. Enhanced IPRs promote domestic innovation as well as help attract Foreign Direct Investment. This is a more productive focus of aid than talking about “flexibilities”, which may tend to discourage development and wealth generation, which are the best guarantees of improved health.



4) Rich countries to incorporate the Paragraph 6 solution into national legislation.

a. The IFPMA agrees and applauds the legislation passed by Canada, the EU and other industrialized countries to implement the WTO Decision of 2003 and the TRIPS Amendment of 2005.

5) UNCTAD, WIPO, WHO to provide “independent” technical assistance re TRIPS “safeguards”

a. The secretariats of both WTO and WIPO make available objective technical assistance to developing countries, to help them to implement all aspects of TRIPS.

b. UNCTAD and WHO have important, wide-ranging policy roles in development and public health, respectively. It is questionable if the limited resources provided to these organizations by Member States to fulfill their primary missions should be diverted for purposes which clearly fall within the mandate of other international organizations, notably WTO and WIPO.