Access to medicines: an obstacle race?
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Balance of the latest negotiations of the WTO in relation to access to drugs.
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The 6th Ministerial Conference of the World Trade Organization (WTO) will begin tomorrow in Hong Kong. This conference is crucial to advance in the negotiations that were initiated four years ago in the frame of the DOHA Program for development, in order to conclude the round in 2006.
The Ministerial Conference is one of the WTO's organs where important decisions about international trade are adopted. Ministerial Conferences have been controversial during past years because even though agreements in order to improve commercial flows between countries have been approved, certain countries have hindered the implementation of these agreements[1].
One of the agreements that raised the most expectation during the 4th Ministerial Conference - which took place in Doha in 2001 – was the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). All commercial products are subject to this agreement, which considers drugs consumer goods. At the same time, the Declaration concerning the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health was formulated. This Declaration recognizes the need for Trade-related Aspects of Intellectual Property Rights Trade to[2] :
• direct their energy to combat public health problems,
• promote the development of new drugs
• and not obstruct the adoption of new measures by the members of the WTO in order to protect public health, such as access to drugs.
For this reason, some safeguards were established in the declaration, like the obligatory licences, through which countries grant the licence to produce a patented pharmaceutical product to a laboratory without the consent of the owner of the patent. This way, the availability and access to drugs is guaranteed in order to protect public health. Nevertheless, the owner of the patent can ask for an economic compensation.
Parallel imports are another existing mechanism through which governments can import, without the owner of the patent's consent, drugs made by the same laboratory which are less expensive in other countries thanks to the competition of generic drugs.
Even though the Doha Declaration gave a step forward, it left gaps in the implementation of TRIPS safeguards, such as less developed countries that do not have the capacity to produce pharmaceutical products.
In the Declaration, it was also agreed to prorogue until 2016 the deadline that the less advanced countries had in order to apply the dispositions regarding pharmaceutical products’ patents. Despite everything, some countries have had to move forward this deadline and assume additional limits have access to the WHO and benefit from the TRIPS safeguards[3].
The case of Cambodge is a powerful example of this double sense in the Doha’s discourse, because in order to become part of the WTO and benefit from the TRIPS safeguards, it has to implement the TRIPS in 2007 instead of 2016 and accept measures from the United States that will obstruct and delay the availability of generic drugs[4].
Just before the Cancun Ministerial Conference in 2003, an agreement was signed that allowed countries with the capacity to produce drugs with obligatory licence to export to countries that did not have the production capacity. Even though this was a temporary exemption until a permanent amendment was approved, it put an end to the gap generated by the Doha Declaration[5].
Now, one week before the 6th Ministerial Conference, the WTO’s members approved that this temporal exemption become a permanent amendment of the TRIPS Agreement. We will have to wait until the conference to know if two thirds of the WTO’s members ratify it.
This amendment includes, among other things, licence to export pharmaceutical products made under obligatory licence to countries without the production capacity; avoid patent owners' double remuneration on the part of the exporting and the importing country, and the development of regional trade systems that involve less developed countries[6].
It seems that the TRIPS Council's aims of guaranteeing public health and promoting access to existing drugs and the development of new ones, should de fulfilled with these agreements and with future amendments.
However, some voices ask for an analysis of the current measures to evaluate their effectiveness in increasing access to drugs. There are fears that the prices of new drugs- such as second generation antiretrovirals - will not decrease as much as the first generation ones did previously[7].
In order to fulfil the TRIPS Agreement, China and India, the main producers of generic drugs for developing countries, had to regulate patent protection and approve new laws regarding this issue.
It is too early to evaluate its impact on the long term, but at the moment, it seems that the availability and the prices of almost 90% of the medicines made in India and China are not affected by the introduction of the patents’ law. However, it would be wrong to conclude that patent protection has a low impact on access to drugs, since new drugs (antibiotics, antiretrovirals, antituberculosis…), that are introduced in the market will be patented after 2005. Therefore, they will benefit from 20 years of protection thanks to the patent, with the consequent monopole on prices, unless the TRIPS safeguards are applied.
Even though some feared that the Indian and Chinese laboratories would lose their interest in low-cost markets due to the implementation of regulations, there is a powerful reason to believe that they will not underestimate it. The maintenance of these laboratories is low, which enables them to face the new fields that they are looking for, such as advance in research, biotechnology and traditional medicine[8].
The lack of access to drugs does not have a sole solution. It is necessary to improve the economical, trade and health politicise at the regional and international level. Therefore, it is essential that the WHO Ministerial Conference in Hong Kong look for a consensus and be aware of the importance of the trade measures that have been adopted in the Public Health field, in order to improve the lack of access to drugs and bring us close to one of the Millennium Goals: “In cooperation with pharmaceutical companies, provide access to affordable essential drugs in developing countries”.
[1] Millennium Project, Task Force on Trade, capítulo 10. http://www.unmillenniumproject.org/reports/tf_trade.htm
[2] http://www.wto.org/spanish/thewto_s/minist_s/min01_s/mindecl_trips_s.htm
[3] “Prescription for healthy development: increasing access to medicines”, UN Millennium Project, Task Force on HIV/AIDS, Malaria, TB and Access to Essential Medicines, 2005. http://www.unmillenniumproject.org/documents/TF5-medicines-Complete.pdf
[4]“El descarrilamiento de Doha”, MSF.
http://www.accessmed-msf.org/documents/cancunbriefingspa.pdf
[5] http://www.wto.org/spanish/tratop_s/trips_s/health_background_s.htm
[6] http://www.wto.org/spanish/news_s/pres05_s/pr426_s.htm
[7] http://www.essentialdrugs.org/edrug/archive/200512/msg00016.php
[8] A Briefing Paper for DFID: Update on China and India and Access to Medicines, noviembre de 2005. http://www.dfid.gov.uk/pubs/files/atm-china-india.pdf
http://www.dfidhealthrc.org/shared/publications/Issues_papers/ATM/Grace2
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