Call For End To Sub-Standard Drugs

50 to 90 per cent of sampled anti-malarial drugs had failed quality control tests.

Countries that produce pharmaceutical products for export should apply the same quality standards specified for products sold in their domestic markets, delegates stressed at a three-day workshop on the World Trade Organisation (WTO) Decision on Access to Medicines at Affordable Prices.

The meeting noted with concern a recent World Health Organisation assessment which showed that between 50 and 90 per cent of sampled anti-malarial drugs had failed quality control tests, while more than half of antiretrovirals tested did not meet international standards.

Organised by the Commonwealth Secretariat's Special Advisory Services Division from 12 to 14 October 2004 in Geneva, Switzerland, the workshop discussed the 2003 WTO decision on access to medicines at affordable prices by countries with no or insufficient manufacturing capacities for pharmaceutical products. It involved discussions on patenting legislation for pharmaceuticals.

Under the WTO decision in August 2003, member governments agreed on legal changes to enable poorer countries to import cheaper generic drugs made under compulsory licensing if they are unable to manufacture the medicines themselves. 

Delegates at the workshop considered three main areas -- quality, safety and effectiveness of products manufactured under compulsory licences; development of regional trade, production and patents; and the special situation of least developed countries. Dialogue was based on case studies commissioned by the Secretariat in nine developing countries: Bangladesh, Barbados, India, Jamaica, Kenya, Mauritius, South Africa, Uganda and United Republic of Tanzania.

Delegates discussed the WTO decision that had resulted in lower priced pharmaceutical products, as in Kenya, where the cost of antiretrovirals to treat HIV/AIDS had decreased by 50 to 70 per cent.

The meeting addressed incentives that could be provided by the governments of countries wishing to encourage the development of domestic pharmaceutical industries. Delegates proposed that collaboration or partnership arrangements with foreign pharmaceutical companies be explored. Participants noted that several countries which are important producers of pharmaceutical products do not require home-based manufacturers to obtain authorisation for export products. Instead, the responsibility for evaluating whether these drugs conform to quality standards falls on the drug regulatory authorities of importing countries. 

Delegates said this was unsatisfactory because the lack of qualified personnel and inadequate laboratories made it difficult for many countries -- especially those with insufficient or no manufacturing capacities -- to carry out independent evaluations. 

There was general consensus among participants that exporting countries can help control sub-standard pharmaceuticals in international markets by ensuring that products are only exported after evaluation by local regulatory authorities.

The outcomes of the meeting will be submitted to the WTO Council on Trade-Related Aspects of Intellectual Property Rights, to inform its future deliberations.

 

CNIS - the Commonwealth News and Information Service Issue 208  3 November 2004