AIDS medicines: the European Union must choose a side

ACT-UP Paris


Last September 19-21 in Geneva, the WTO's Council of TRIPs (Trade-Related Intellectual Property) met to prepare next November's World Trade Ministers' Conference in Doha, Qatar.

This meeting was seized by 52 developing countries as the occasion to ask the WTO to declare in Doha that "nothing in the TRIPs Agreement prevents Member States from taking measures to protect public health". They want to be able to manufacture or import generic health products without fear of trade sanctions or economic pressures from the developed countries. The United States, Japan, Canada, Switzerland and Australia are opposing this proposal and striving to stifle it.

Meanwhile, the European Commission chooses to rely on abstruse language in order to avoid the issues and needs clearly brought forward by developing countries and to bring its support to the adverse position led by the United States.

International civil society has already had the occasion to witness the way that the EU, under cover of providing a so-called mediating ground, in truth does the US' work of ridding developing countries' proposals from all concrete or effective measures, as happened at the last Health Ministerial in May (see pan-NGO press releases of the time).

Last September 18, Trade Commissioner Pascal Lamy restated that the DG-Trade had entered 18 months earlier into a consultation with civil society with a view to putting the European position in adequation with poor countries' populations' needs.

During these 18 months, over 5 million people without access to treatment died of AIDS. Seeing the Commission's position at the WTO, it appears perfectly clear that this consultation process was in truth a masquerade. In practice, the Commission is continuing its policy of blocked treatment access on the millions of people living with fatal diseases in poor countries.

On October 4, the European Parliament adopted a resolution for the Commission mandating that the EU promote the recognition, at the international level, of developing countries' right to domestically produce and market generic medicines aimed at treating major epidemics, without regard for intellectual property-related costs.

The EuroParliament also deplores that "countries which took steps to implement safeguard clauses in the TRIPs Agreement suffered pressures to abandon the related measures" and considers that "the Commission and the Union's Member States should defend [...] developing countries' right to use all the safeguard clauses provided in the WTO's TRIPs Agreement, in all the aspects provided in the Agreement (compulsory licensing, parallel importation, essential generic medicine production, Bolar provisions, etc) and if unsufficient, should ask, at the WTO, an adaptation of the TRIPs Agreement".

In this context, it is unacceptable that the European Commission, acting in contempt of Parliament and of its own consultation process, continue to block access to treatment for people with fatal diseases in poor countries

In Doha, the Trade Ministers of the world will ratify a declaration which will set out the rules of international trade for the next few years. In times when the annual tally of world treatable disease deaths is shooting past the 10 million human beings mark, the stakes are overwhelming. Affordable quality medication must be produced and distributed throughout the developing world now, without hindrance from economic pressures. The rules of the game need to be changed. The European Union can no longer continue to block access to treatment.

(Below, comments by Act Up-Paris on the European Union's infamous WTO "non-paper" of September 21, 2001).


Act Up-Paris comments on European Commission non-paper, "Draft Declaration on TRIPs and access to affordable medicines", distributed on the Septembre, 21.

Ministers,

Recognizing that access to health care and medicines for all, and especially the poorest populations of the globe, is one of the major challenges for the global community and to its sustainable development;

Conscious that improving health and combating poverty requires a mix of complementary social, economic, and health policies and practices and is, therefore, the common responsibility of many international organisations, governments, non governmental organisations and private actors;

Acknowledging that accessible price is one of the determinant factors of access to medicines, alongside efficient infrastructure to distribute, deliver and monitor drug usage and provide necessary information and education, and increased research and development and mechanims to finance drug purchases;

Indeed, accessible price is a determinant factor of access to medicines. It is this regards which concerns the commission's position at WTO and the council of TRIPS.

As for the other determinants of access such as infrastructures and finance mechanisms, which are outside the WTO mandate, it is now time for the Commission to implement the action plan that has been passed in Parliament last year, and to overcome its failure to spend the 23 billion euros sleeping in the European Development Fund.

Let us avoid obvious mistakes : R&D DOES NOT make medicines accessible. It certainly causes for new medicines to become available, however it has no incidence whatsoever on whether medicines are or are not accessible for patients. That is the whole point of developing countries' proposal to the TRIPs Council : drugs into bodies - not drugs on the market.

Recognizing that prices for medicines should adequately reflect the differences in cost of living and purchasing power between developed, developing and least developed countries;

Welcoming that interested parties continue their efforts to establish global tiered pricing system for medicines in view of ensuring sustainable supply of affordable medicines to the poorest;

In view of "ensuring sustainable supply of affordable medicines to the poorest", the Commission should not forget the fact that effective tiered pricing depends on successful generic competition, in the sense that mere discount negotiation with pharmaceutical corporations is a mechanism unable in itself to sustainably guarantee lowest possible prices for all lifesaving drugs.
Recalling the mandate of the TRIPs Council that Members would, within the TRIPs Council, work on "the interpretation and application of the relevant provisions of the TRIPs Agreement with a view to clarifying the flexibility to which Members are entitled under the Agreement and the relationship between the TRIPs Agreement and affordable access to medicines";
The Commission exhibits blindness to the criticality of the matters under debate and the extent of global mobilization, by governments and civil society alike, in choosing for a goal the discussion of administrative procedures in a bureaucratic framework, when expectations are on the level of the utmost urgency : results in access to lifesaving drugs. The context for developing countries' clear proposal that nothing hinder access to health comes in the wake of 10,000 aids deaths in the world each day.
Remaining strongly committed to the TRIPs Agreement and its implementation;

Considering that intellectual property rights provide an essential stimulus for creativity and innovation, that these rights need to be adequately protected in order to encourage and secure investment in research and development of new medicines, and particularly those targeted at the major communicable diseases;

Recognizing therefore that intellectual property contributes to serve public health objectives globally;

On the topic of the value of intellectual property protection (IPP) as incentive to R&D on the diseases of the poor, the Commission's position in the TRIPs Council is in blatant contradiction with its position in the Civil Society Consultation (CSC) : at the May 28 CSC meeting, Mr Jean-Charles Van Eckhaute, TRIPs expert in the Commission's intellectual property department, stated that intellectual property protection and market forces are unable to provide R&D where there is no solvent market.

Thus, this statement on the innovation incentive seems completely outside of topic, and can only be construed as extremely inopportune propaganda.

On contrary, the Commission should insist on the fact that unalleviated implementation of intellectual property protection causes situations of monopoly thereby excluding poor countries from access to Western health innovations - a fact which is exemplified with the fullest violence in the case of newest-generation, potent HIV/AIDS drugs.

Furthermore, in the strictest public health point of view, the fact is that intellectual property imposes significant limitations to drug development by preventing certain categories of technically simple, patient-oriented innovations (such as CIPLA's once-a-day triple therapy Triomune) which, due to IPP, remain only available to a very few patients in a very few countries.

Therefore, in this context, there can be no justification for the Commission's commitment to the TRIPs Agreement and its implementation, and no need to recall it in this non-paper.

Concerned about the lack of adequate research and development on medicines for the prevention and treatment of diseases predominantly affecting people in developing and least-developed countries;
Concerned about lack of research on diseases of the poor, and having recognized in the CSC that Intellectual Property Protection can not generate research for the un-solvent, the Commission should consider financial support to public research efforts in developing countries.
Recognizing that intellectual property is one of the factors which have a bearing on the price of medicines;

Confirming our belief, that, in accordance with Article 7 of the TRIPs Agreement, the protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations;

The Commission is perfectly aware of the fact that poor countries never received any technology transfer as agreed in the TRIPs because these clauses were not binding. This is what the OAU countries pointed out to Commissioner Lamy at the 2000 Trade Ministerial Summit in Libreville.

Thus, the Commission should refrain from referring to technology transfer until European commitments in that regard have become reality.

Affirming that the TRIPs Agreement provides for the necessary flexibility to allow WTO Members to determine how to strike that balance between the respective interests, rights and obligations of right holders and consumers, and in particular to implement an intellectual property regime that is supportive to their public health objectives;
Why then do HIV/aids drug copies remain unavailable in the vast majority of aids-ridden poor countries ? Why then do 52 countries ask for a clarification of the right under TRIPs to take measures to protect public health, such as resort to drug copies ? And why is the EC so reluctant to affirm in Doha that nothing in the Agreement prevents countries from taking measures to protect public health ?

By this absurd affirmation the Commission not only ignores and denies the point made by 52 Member States to the WTO and several hundred civil society organizations, but also chooses a policy which borders on the murderous, while 10,000 people die of AIDS every day.

Recognizing that compulsory licensing and parallel imports may under circumstances be used as tools to ensure supply of affordable medicines to populations which would otherwise not benefit access to such medicines;
A this stage the Commission should say that compulsory licensing and parallel imports have to, not "may", be used to ensure supply of affordable medicines to populations which would otherwise not benefit access to such medicines. In the present situation the Agreement isn't sufficient to unable poor countries to authorize drug copies ; rather than paraphrasing the text of the agreement, the Commission should specify that nothing in the TRIPs prevents countries from using generic medicines.
Taking note, in particular, of the fact that certain Members may have very limited or non-existent industrial capacity as well as a very small domestic market, making it in practice impossible to make full use of the rights provided to these Members by Article 31 of the TRIPs Agreement;
The Commission restricts here the rights provided in Article 31 to domestic use (whereas 31.k also provides for use for export), which is an unduly narrow view of the Agreement. Furthermore, in response to the fact that many least developed countries lack industrial capacity, the Commission's duty is to implement technology transfer and development support to a degree consistant with needs. In particular, the Commission should respond to the urgency of the current global health crises by supporting poor countries in their efforts to avail themselves on the international market of quality, affordable, generic medicines.
Recalling the Preamble of the TRIPs Agreement, which, among others, prescribes that measures and procedures to enforce intellectual property rights shoud not themselves become barriers to legitimate trade and recognizes the special needs of the least-developed country Members in respect of maximum flexibility in the domestic implementation of laws and regulations in order to enable them to create a sound and viable technological base;

MINISTERS DECLARE THAT

1. The TRIPs Agreement shall be implemented in a way as to ensure access to affordable medicines for all in the context of public health policies.

If the EC sincerely thinks the TRIPs should be implemented as to ensure access to affordable medicines for all, then it should affirm that "nothing in the TRIPs prevents Members from taking measures to protect public health" as the 52 developing country Member States are asking in their Doha declaration proposal.
2. Each provision of the TRIPs Agreement should, in accordance with Article 31 of the Vienna Convention on the Law of the Treaties, be read in the light of its object and purpose as set out in Articles 7 and 8 of the TRIPs Agreement.
AIDS constitutes an unprecedented epidemic in scale, impact and global spread. It is in this context that the most affected countries feel that the Trade Ministerial must officially declare that nothing in the TRIPs Agreement prevents countries from protecting public health and access to health. How serious is it for the Commission to come up with a proposal that the Trade Ministerial officially declare that the TRIPs Agreement should be read as it already says it should be read ?
3. Article 31 of the TRIPs Agreement, which prescribes the conditions under which Members can grant compulsory licenses, leaves WTO Members the freedom to determine the grounds for granting compulsory licenses, provided the terms and conditions set out in the Agreement are met.
As the Commission points out in the least direct manner, articles 7, 8 and 31 of the TRIPs are supposed to allow for public health protection and public interest promotion, while enhancing technology transfer.

Yet what the AIDS epidemic so far is showing is that greater intellectual property protection, which is supposed to "contribute to the promotion of technological innovation and to the transfer and dissemination of the technology, to the mutual advantage of producers and users of technological knowledge and in a manner conductive to social and economic welfare, and to balance of rights and obligations", in practice is only conducive to poor public health and acts as to block access to life-saving medications for entire populations living in poor regions.

Article 8 offers that "Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sections of vital importance to their socio-economic and technological development []". However, in reality many Members have faced intense lobby and considerable pressure both from industry and most-developed countries so that they pass laws and regulations excluding recourse to these TRIPs-compliant measures. On top of this, in those few undeveloped countries where the government resisted initial pressures and did pass legislation allowing recourse to these measures, then the pressures redoubled and concentrated on precluding the implementation of these measures.

Likewise, article 31 theoretically permits the use of a pharmaceutical patent's subject matter without the permission of the IPR holder (compulsory licensing). In reality not even a single compulsory license has yet been granted in a poor country in order to remedy a blocked treatment access situation (through the local production or the importation of cheaper generic medicines), while the world's most developed countries routinely compulsory-license IPRs to remedy blocked competition situations.

The EC is perfectly aware of this absurd, gross imbalance in the TRIPs Agreement and its implementation. The Commission must recognize, and emphasize, the fact that in reality articles 7, 8 and 31 of the TRIPs Agreement do not satisfyingly permit the protection of public health imperatives.

Indeed, the inherent imbalance is such that the WTO's most developed Member, the United States of America, remains in perfect safety from dispute settlement procedures while itself in gross violation of the Agreement (for instance, the US does not proceed to the evaluation of the individual merit of each compulsory license on a case-by-case basis, as the TRIPs mandates). For these reasons, the WTO has to state clearly that health, as the most vital form of public interest, must prevail against any particular interest economic or other, and that nothing in the TRIPS agreement prevents Members from protecting their population and from promoting public health. Furthermore, the seriousness of the global AIDS pandemic demands that coercive measures be adopted so that WTO Members face sanctions should they abuse bilateral trade diplomacy to impose death-causing legislation or practices.

If the WTO is unable to ensure that the safeguard provisions be implemented wherever and whenever necessary, and more generally that the TRIPs pose no threat to world health, then neither TRIPS, nor WTO, should be maintained.

4. Each compulsory license must be considered on its own merits.
If this is the Commission's profound concern, the EC, in the 6 years since the Agreement was signed, should have entered in discussions with the United States to press them to change their law and practices into accordance with this point, instead of supporting the criminal US attitude towards poor countries.
5. In the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use, Members may, subject to Article 31 (b) of the TRIPs Agreement, grant compulsory licenses without prior efforts on the part of the user to obtain authorisation from the right holder. Epidemics of life-threatening communicable diseases can qualify as situations of 'national emergency' or as a 'circumstance of extreme urgency' within the meaning of Article 31 (b) of the TRIPs Agreement.
Again the Commission proposes that the Trade Ministerial declare that what is in the Agreement is in the Agreement. This would be merely unserious if it didn't fall so extremely short of the stakes involved with the global aids epidemic.

What is the Commission's point in paraphrasing Agreement safeguard provisions which are unimplementable in practice, when this unimplementability is the very reason why the debate has come to on the WTO table in the first place ?

In the absence of concrete, additional garantees from the WTO that nothing in the Agreement prevents Members from protecting public health, these paraphrasing proposals by the Commission are only, and shockingly, pointless.

6. The TRIPs Agreement leaves Members the freedom to choose the exhaustion regime that best suits their intellectual property objectives.
Again the Commission chooses to reply to poor countries' need for additional safeguards by restating Agreement safeguards. In the absence of concrete, additional garantees from the WTO, these paraphrasing proposals are pointless.
7. Intellectual property rights are exhausted, within the meaning of Article 6 of the TRIPs Agreement, when the goods to which these intellectual property rights apply have been put on the market by the right holder or with his /her consent.
This careful formulation by the Commission doesn't say anything about the issue, which is parallel importation, since the Commission doesn't specify whether its proposed definition of IPR exhaustion applies to the market of exportation or to the market of importation.
8. Whatever the exhaustion regime chosen, Members will consider all necessary measures to prevent that pharmaceuticals imported under a tiered pricing scheme or supplied under aid-schemes leave the market to where they are originally destined or (re-)enter markets which are not eligible for lower prices.
Firstly, in terms of sustainable public health policy measures, drug aid is only a very minor issue, which goes in sharp contradiction with the degree of attention which the Commission gives it and wishes the Ministerial to give it. Also, if one is intent on policing drug aid, there are a great deal more worrying problems than cross-market leakage. Policing drug aid calls first for sharp controls to be imposed on the many abuses on the spirit and letter of the relevant law by the proprietary pharmaceutical industry which are vocally decried by the majority of involved NGOs and public health experts ; it only incidentally calls for controls on corporate donation trade.

Secondly, concerning tiered-pricing and reimportation, there is no historical precedent for preventing the exportation of legal goods, while there are innumerable precedents for preventing importation of illegal goods. Why does the Commission choose to ignore the simple, tried-out way of illegal importation prevention, to focus instead on the chimera of legal exportation prevention ?

9. The obligation under Article 39.3 of the TRIPs Agreement to protect test data against unfair commercial use and against disclosure should not be interpreted in such a way as to weaken or nullify Members' rights under other Articles of the TRIPs Agreement, such as the possibility foreseen under Article 31 (b) of the TRIPs Agreement to grant compulsory licenses without making prior efforts to obtain authorization from the right holder in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use.
This again falls short of spelling out the right of governments to disclose original data to copy manufacturers. Also, the Commission takes a surprisingly restrictive view of cases of disclosure when solely considering disclosure from a drug regulatory agency to a copy manufacturer, as opposed to disclosure from one drug regulatory agency to another. Indeed, the problem with pharmaceutical test data and AIDS is that most poor countries have registered the HIV drugs on the simple basis of registration in the US or Europe, that is to say, without having received the original test data. The Agreement imposes test data protection against commercial use, not against public use : the real issue thus is, when will developed country governments disclose aids drug test data to undeveloped country governments, so that they may assess copy drug quality assurance data in full intelligence?
10. Developed Members are urged to provide technical assistance for the implementation by the least developed countries of their obligations under the TRIPs Agreement, while taking into account health concerns.
Developed countries are falling over each other to assist poor countries in implementing their IPP obligations under TRIPs, but they have nothing to reply to the complaints of countries such as Egypt or Mauritius about the fact that they have systematically reneged on their own technology transfer commitments under TRIPs (which represented when the Agreement was signed poor countries' only incentive in accepting Western IPP standards).

How does the Commission intend to strengthen the TRIPs Agreement if it takes part of an approach of TRIPs which instrumentalizes the Agreement to force poor countries to stop copying Western IP without concern for the millions annual deaths which ensue from blocked access to copies, while at the same time systematically reneging on their moral and legal duty to provide financial and technical assistance to poor countries in protecting and providing care for their populations? Instead of urging poor countries to protect IPP, the Commission ought to make all haste implementing the recently passed Programme for Action against AIDS, Tuberculosis and Malaria, by supporting financially and technically the manufacture, registration and distribution of medicines as well as other aspects of comprehensive care for people with communicable diseases.

11. The TRIPs Council will call for closer co-ordination between WTO, WIPO, and WHO.
The TRIPs Council and WIPO need to let WHO do its job in peace ; rather than coordinate with them, the TRIPs Council needs first to recognize the primacy of health objectives over trade and the imperative of protecting populations' interest rather than corporations' interests.
12. In view of the special needs and requirements of least-developed country Members, their economic, financial and administrative constraints, and their need for flexibility to create a viable technological base, Members will, in due time positively consider individual requests for extension of the transitional period provided for their benefit under Article 66.1 of the TRIPs Agreement.
Extension of the transitional period partakes of the same imperative as that of declaring officially that nothing in the TRIPs Agreement prevents countries from taking measures to protect public health : the primacy of public interest against private interests, of human life over profits.

Act Up-Paris.


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