If implemented, several aspects of the IGWG’s current Draft Plan of Action would not only increase the cost of medicines, but also jeopardise patient safety in the poorest countries.
We are particularly concerned with the parts of the Plan that envisage increasing access to medicines by scaling up local pharmaceutical production in Less Developed Countries, to be underwritten by the compulsory transfer of technology and intellectual property:
• Patient safety: Given that only 20 per cent of WHO’s Member States have well-developed regulation, it is difficult to see how manufacturing capacity can be scaled-up whilst adhering to necessary quality standards. Although National Drug Regulatory Agencies look to WHO for regulatory leadership, in reality WHO is powerless to act when Member States trade in medicines of substandard quality. If the IGWG results in an increased supply of substandard drugs, this will inevitably lead to more cases of clinical failure, and in the cases of malaria and HIV/AIDS, mounting resistance to existing treatments.
• Costs: Expanding manufacturing capacity in African countries will be highly expensive, requiring significant amounts of start-up capital and funds for ongoing operations. Several current ‘local production’ efforts have led to drugs that are considerably more costly than alternative products. Funds could be more effectively used on other pressing health issues, such as improving the quality of infrastructure.
• Compulsory licenses: Producing drugs of known quality, safety and efficacy is costly and time consuming. Member States should learn from the experience of Canada’s Access to Medicines regime, which has been effectively abandoned without delivering one drug – even with a government subsidy.
Moreover, the Draft Plan of Action ignores Member States’ previous requests to review existing R&D activities before starting a new forum. Evidence shows that R&D into Type II and Type III diseases is currently taking place at an unprecedented rate. The Secretariat has not indicated how the IGWG will avoid costly duplication of this work.
These concerns are set out in detail in the enclosed document. On behalf of supporting organisations, we respectfully urge your government to review it before the next meeting of IGWG that begins on the 28th April 2008.