> by Helen Gavaghan

GENEVA: "Unless we implement quickly we end up just talking, talking, talking, and that has been typical of previous meetings." This was the view expressed by the Kenyan delegation on the second day of last week's WHO-sponsored first meeting of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG).

It was a week of talks from 4-8 December that ended with the US delegate being the first to urge that the global strategy document, one of the meeting's two outcomes - the other being a collation of implementation proposals - with its human rights' underpinnings, be referred to his and his colleagues' capitals.

With that referral the delegates met their essential strategic goal for the week, which was to begin the process of meeting a resolution passed in May this year by the WHO's World Health Assembly, "to secure an enhanced and sustainable basis for needs-driven, essential health research and development, relevant to diseases that disproportionately affect developing countries, proposing clear objectives and priorities for research and development, and estimating funding needs in this area". This was the task given to the IGWG, which was created for the purpose.

The next tactical step is to make sure that by the end of January 2007 the WHO-based secretariat of the IGWG has all the proposals and ideas on the table for production of a document to be submitted via the WHO's Executive Board (a subgroup of 32 Nations with rotating membership) to the next World Health Assembly in May 2007. This will be the document that forms the basis of negotiations among the Member States of the IGWG. According to the current timetable, a final strategy and work plan, of as yet uncertain legal status in international law, will be submitted to the WHO's World Health Assembly in May 2008.

In the meantime a subgroup of nations led by Switzerland is seeking early implementation of a number of measures. Whether such national cherry picking at this stage, in preparations for negotiations, is compatible with the idea declared from the podium that when the negotiations begin "nothing is decided until everything is decided" is unclear, yet a number of nations already have measures going though their parliaments. For example, Switzerland is in the process of revising its patent law.

By the week's end exhausted delegates had amended and appended to their strategy so much that some of it had disappeared - notably, and seriously, their thoughts on sustainable finance. But they had added to the action plan presented to them by the secretariat at the beginning of the week, and hammered out a raft of ways to fulfil eight elements. These were:

• prioritising research and development needs;
• promoting research and development;
• building innovative capacity;
• transfer of technology for innovative capacity;
• management of intellectual property;
• improving delivery and access;
• ensuring sustainable financing mechanisms; and
• establishing monitoring and reporting systems.

Technology transfer and managing intellectual property were topics added to the original six by the delegates during the week.

However the nations were - and are - not yet negotiating, simply collecting what their delegates see as the facts and proposals they will need when they do negotiate, as the Canadian chair of the meeting, Peter Oldham, repeatedly reminded the delegates. The meeting was guided in its work by the weighty report of the Commission on Intellectual Property Rights, Innovation and Public Health (CIP-IPH), published in May this year by an international group of experts commissioned by WHO (see below for reference).

The IGWG meeting's documentary output, in its dry and painstaking way, covered a vast amount of ground. It seeks to pick a prioritised path among customs and excise duties (Switzerland wanted the elimination of duties and charges on pharmaceuticals), supply chains, regulatory harmony (China emphasized this issue), clinical trial management, advanced purchase schemes to speed drugs through their last days of development, good manufacturing practices, proposals for annexed national budgets, compulsory licensing, boosting manufacturing capacity, expanding technological know-how, physical infrastructure weaknesses, varied educational standards, low budgets, public-private partnerships, technology transfer, access to compound libraries, patent pooling and so on.

And on top of that the delegates need to apply each approach in different national settings, in such a way that appropriate, relevant research into illnesses as diverse as HIV/AIDS, leishmaniasis, leprosy, heart disease and cancer - with non-communicable diseases increasingly becoming developing country problems - can be given the boost it needs.

Both the output documents - the strategy and the collation of implementing proposals - build on a decade of thought about the relationships among innovation, public health and intellectual property rights, as the Brazilian delegation was keen to emphasize.

An Indian proposal on the first day for a third document, focussing on financial issues, had dropped from recorded view by the end of the week. India had, with some backing from Ghana, suggested on the first afternoon of the meeting that a central plank of this document could be a Trust Fund, created to provide financial support to poor countries, and that the Fund and its access rules could be managed under the aegis of the WHO. The other substantive financial suggestions made during the week included ring-fencing 0.7% of a country's gross domestic product to finance the IGWG's mandated aims, but there was to be no financial document in which these might have been emphasised.

Whether the papers that were prepared will end their days as a formal Treaty, a Convention or a mixed package of measures having less formal status was, by the last day of the meeting, unclear. At least that was the view Oldham, with his background of working for Canada's Department of Foreign Affairs and International Trade, seemed to be expressing when he shrugged non-commitally in response to a question about the meeting's long term legal outcomes.

It was notable that few of the low-income countries were present. Currently the less affluent member states can claim airfare but not accommodation costs, and one possibility, which a member of the meeting's secretariat brought to RealHealthNews' attention, was that it would help if the WHO made amendments permitting it to pay the accommodation costs of one delegate [per low- or middle-income nation] at future meetings.

So, what did those who were present from Africa and other countries with large numbers of people living below the poverty line and with poor access to life-saving or life-enhancing health care have to say for the record? Certainly Oldham kept their noses to the grindstone, urging them to keep all their comments for the public record to those created during the plenary sessions.

On the second day of the conference he asked, "What can a group this large and diverse do? We have 60 recommendations from the CIP-IPH, chaired by Ruth Dreiffus, a left-leaning Swiss politician; a dedicated secretariat for the intergovernmental working group; documentation [available on the WHO web site, see below]; a public consultation [also on the WHO website]; skill and expertise nationally and internationally; the context of other realities and issues; and, finally, we have a goal, which is to find methods of meeting the needs of the poorest of the poor."

Among the barriers to the development of new medicines, argue NGOs such as Médecins Sans Frontières, is the poor incentive that patents or commercial benefits from intellectual property offer for the provision of medicines, vaccines and diagnostics when those affected by the disease are without purchasing power, political, commercial or financial muscle. Other potential incentives, argues James Love from the Consumer Project on Technology, in a submission forming part of the public consultation made to the WHO prior to last week's meeting [see below] include offering prizes for innovative work.

Certainly it is a point of agreement among Member States, organisations and interest groups, that there is a need for more research and development into the diseases that disproportionately affect the poor and needy. "It is not just neglected diseases, but rather neglected people, that should be our main concern," wrote Dreiffus in her preface to the Commission's report.

All who spoke stated in some form of words that it was their intent to participate constructively to meet the WHA's mandate, and most said they needed guidance in setting priorities. Yet it is the delegates themselves who are mandated to set priorities, and it is the country delegates who know the specific needs of their respective countries and so can shape the policy.

Of all the delegations India seemed most well prepared, both on the floor in its diplomatic guise and politically in the convention centre's corridors. Their delegation head, Naresh Dayal, from the Ministry of Health and Family Welfare, told RealHealthNews, "Our burden of traditional communicable disease is expected to decrease by 15% during the next five years, whilst we anticipate an 18% increase in non-communicable disease in the same period, the worst being diabetes where we expect a 35% increase."

Dayal added that India now has seven or eight multinational pharmaceutical companies and is in a position to manufacture medicines at a very low cost and to supply other countries "which may not have the same manufacturing capacity as us". Already, he says, India provides 90% of the world's measles vaccines.

Though India is an economic powerhouse and set, says the World Bank, to become the most populous Nation on Earth, Dayal says one needs to look beyond the country's economic growth, which has been 8-9% in the past two to three years. "India is a country of contradictions and large parts of it are poor," said Professor N. K. Ganguly, Director-General of the Indian Council of Medical Research. One third of India's population is the equivalent of 300 million plus people. There is also, says Ganguly, a lack of knowledge about how to access social development.

In its diplomatic guise on the international stage of the IGWG, India (which with the support of Finland and Singapore proposed Oldham to chair the meeting) emphasized the need to shape medical research to take account of gender; and spoke strongly in support of South-South collaborations.

The other Member State most visible diplomatically and politically was Switzerland. Though it has not yet responded specifically to the recommendations in the Commission on Intellectual Property Rights, Innovation and Public Health Switzerland has developed a number of measures that parallel international thinking and are intended to meet the health research needs of developing countries.

For example, the Swiss Tropical Institute is realigning itself with the Federal Institute of Lausanne, which is now establishing an Institute for World Health, whilst the Bill and Melinda Gates Foundation is working with the Swiss Government to create a Swiss Institute for vaccinations.

Switzerland also hosted a mini-meeting away from the plenary session at its Ministry to consider advanced implementation measures. To the outsider it seemed that such a meeting contravened the elected chairs' view that all substantive issues be discussed on the floor of the plenary sessions. But Alexandre von Kessel, deputy head of section for International Organisations at the Swiss Federal Office of Public Health, said that such meetings were legitimate and ought not to bring down a rebuke on Switzerland from the chair.

At the time of going to press RealHealthNews had not clarified whether that was true or whether such breakaway meetings can impair unity and harmonious negotiations. Nevertheless three issues won unanimous support from those countries that attended this breakaway meeting (including India):

• the idea that a further forum be formed of all groups with an interest in the IGWG's mandate, ranging from pharmaceutical companies to NGOs;
• that there be voluntary reporting to a central register of actions taken by Member States which are actions reflective of the Commission's recommendations; and
• the identification of research gaps.

During the coming months these thoughts will feed with others into IGWG's secretariat and guide the next steps in the intricate international dance through which nation's sometimes mediate their relationships.

And was it all worthwhile? On the debit side, WHO paid US$600 000 toward the cost of the meeting; and the Swiss government provided the conference facilities. On the credit side, we will have to wait and see.