Access to medicines in poor countries: How the EU is backtracking on its Doha commitments

February 10, 2003

The solution to the problem raised by paragraph 6 of the Doha declaration on TRIPS and Public Health must:

>From Doha 2001 to Geneva 2002: background:

In November 2001, following intense negotiations, the 142 members of the WTO signed the Doha declaration on TRIPS and public health - a text that gives countries clear rights to prioritise public health over intellectual property. This represented a huge step forward for access to medicines in developing countries.

Mr. Lamy welcomed the agreement: "I am glad we have clarified that WTO Members have the right to grant compulsory licenses to produce medicines and the freedom to determine the grounds, such as public health interests, upon which such licenses are granted."

The Doha declaration left one key issue unsolved: countries were able to decide what public health problem warranted issuing a compulsory license, but to whom would a country with insufficient manufacturing capacity deliver the license to? Where could such a country import the product from?

The TRIPS agreement allows a country to produce a generic version of a patented product under compulsory license, but this production has to be "predominantly for the domestic market". This quantity may not be sufficient to ensure production of a product and/or there may not be a market at all in the potential producing country that would justify the local industry engaging in such a process. It is simply economically inefficient to have domestic productions for every medicine a country may need. The problem of these restricted possibilities of importing - exporting needed medical products was recognized in Doha in the paragraph 6 of the declaration.

Proposed solutions to the paragraph 6 issue were reviewed in increasingly intense negotiations throughout 2002. TRIPS Council's Chairman Motta's 16th December text was the last proposal to be discussed. It was viewed by most delegations as a compromise that was far from ideal, because it failed the test of being simple, workable and economically viable. In any event, on the eve of Christmas, negotiations failed: although other Members seemed ready to compromise on Motta's proposal, the USA effectively blocked the agreement, insisting that the scope of diseases covered by the text was too broad.

The Motta text and Commissioner Lamy's proposal:

Médecins Sans Frontières (MSF), HAI and Oxfam and the World Health Organization (WHO) have come to the same conclusions in terms of what solution is needed to address public health concerns.

In its intervention at the TRIPS Council on September 17, 2002, the WHO stated that the features of a solution which are desirable from a public health perspective must be:

"simple and speedy legal procedures in the exporting and importing countries; equality of opportunities for countries in need of medicines, even for products not patented in the importing country; facilitation of a multiplicity of potential suppliers of the required medicines, both from developed and developing countries; and broad coverage in terms of health problems and the range of medicines.
Thus, the basic public health principle is clear: the people of a country which does not have the capacity for domestic production of a needed product should be no less protected by compulsory licensing provisions (or indeed other TRIPS safeguards), nor should they face any greater procedural hurdles, compared to people who happen to live in countries capable of producing the product.

Among the solutions being proposed, the limited exception under Article 30 is the most consistent with this public health principle."

Chairman Motta's text of the 16th December already did not meet these requirements, and the proposal by EU Commissioner Lamy could in fact make matters worse. What are some of the problems with Motta's text and Lamy's proposal?

Disease Scope

The scope of diseases was already extensively discussed in Doha. The consensus was that there would be no limitations on diseases, and the 142 countries agreed to use the non-restrictive term "public health problem". Paragraph 4 of the Declaration gives the important general principle: "the Agreement can and 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." Countries have a right to decide for themselves what constitutes a public health problem and how to address it. Paragraph 6 makes no reference to limitation on diseases.

Developed countries are trying to slip back in the language that was kept out in Doha by introducing different rules for different diseases. The US has been most obvious in this respect, demanding that the whole solution be limited to applying to "AIDS, TB, Malaria or other infectious epidemics of comparable scale and gravity".

Commissioner Lamy's proposal reads:

"This [agreement] covers at least HIV/AIDS, malaria, tuberculosis, yellow fever, plague, cholera, meningococcal disease, African trypanosomiasis, dengue, influenza, leishmaniasis, hepatitis, leptospirosis, pertussis, poliomyelitis, schistosomiasis, typhoid fever, typhus, measles, shigellosis, haemorrhagic fevers and arboviruses. When requested by a Member, the World Health Organization shall give its advice as to the occurrence in an importing Member, or the likelihood thereof, of any other public health problem."
Lamy's suggested list includes only infectious diseases (i.e. it excludes non-infectious diseases) and, apart from HIV/AIDS, the diseases chosen are those for which there is either no treatment, or for which the treatment is so old that patent protection no longer applies. In other words, this long list of diseases can easily be added to the US proposal without inconveniencing patent-holders.

Lamy's proposal suggests that for any public health problem not included on the list, countries could consult with the WHO. In effect, this means that while WTO Members with manufacturing capacity have the right to use compulsory licensing to combat any public health problem they choose, WTO Members without this capacity could end up under pressure to let WHO make their public health decisions for them. What individual countries regard as a public health problem should be a sovereign decision for them alone, and the WHO itself has said this very clearly. This proposal therefore fails to honour the Doha commitment.

Both MSF and WHO reject the very idea of a list. A list of diseases, even if it is only supposed to be by way of example, will always be used with a presumption against diseases not included. If any list were to be considered though, a "negative" list of diseases which are not covered by the agreement would be best. Let the US and the EU justify why they can have access to effective compulsory licensing provisions to address asthma and diabetes, for example, but developing countries cannot.

Economic viability

An annex in the Motta text includes definitions relating to manufacturing capacity and whether or not a country can use the proposed solution. As it stands, the draft text could be taken to mean that any domestic manufacturing capacity that could make the drug, however inefficiently, could be regarded as sufficient for a country's needs. The tremendous success of producing generic ARVs for US$300 per patient per year only came about because a market of the size and comparative wealth of Brazil was able to do the purchasing. Without the pull of a viable market for generic versions of pharmaceutical products, no manufacturer can rationally be expected to take part in the production for export system, and WTO Members hoping to use the solution will be unable to find a product source for import. The system will have failed them.


Under the current Motta text, the compulsory license system is far more complicated than the "ordinary" TRIPS rules. The TRIPS Agreement lays out the process to be followed when a country decides to issue a compulsory license. Under certain circumstances it also states that a product manufactured under compulsory license may be exported. Nowhere does it mention an obligation to notify the WTO about type of product, quantities, and duration of the license. Complicated, expensive, burdensome procedures of the sort that Motta calls for could make the solution to paragraph 6 impractical and inefficient, and will fail the requirement to put all WTO Members on an equal footing.

Prejudice to other solutions

The Motta text does not make clear that other alternative solutions, such as exceptions under Article 30 mentioned above (e.g. the amendment 196 of the review of the pharmaceutical legislation), could be used if the Motta text is adopted. This should be explicitly stated in the agreement.

The World Health Organization

In Lamy's proposal, the EU recognises WHO's role and expertise on the issue of access to essential medical products. We welcome this recognition, and regret that WHO's earlier intervention on this issue was considered inappropriate by the EU. WHO should be more firmly involved in WTO discussions and decisions which affect public health. This May, the World Health Assembly will discuss access, TRIPS and innovation. This will be an excellent opportunity to discuss how the TRIPS agreement affects the availability of affordable generic medicines, and measures countries can take to protect public health from the effects of stronger patent protection.

For any additional information, please contact:
Seco GERARD, Médecins Sans Frontières
Access Campaign EU Liaison Officer
MSF International Office
Rue de la Tourelle 39, 1040 Brussels
Tel. +32 2 234 62 52
email :

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