E-drug: WTO wrestles with access to cheap drugs solution
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http://www.thelancet.com/journal/vol360/iss9346/full/llan.360.9346.news.23271.2
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Policy and people
World Trade Organization wrestles with access to cheap drugs solution
Lancet 2002; 360: 1670 (23 November)
The World Trade Organization (WTO) held a "mini-ministerial" meeting in
Sydney, Australia, last week, to resolve by the end of the year how poor
nations can get access to cheap drugs. The meeting focused on the Agreement
on Trade Related Aspects of Intellectual Property Rights (TRIPs), which
governs the content of domestic patent law and how it influences access to
pharmaceuticals.
Last year in Doha, Qatar, the WTO softened the impact of TRIPs with the
"Doha Declaration", which states that during a national emergency--such as
"HIV/AIDS, tuberculosis, malaria and other epidemics"--it is permissible for
a country to grant a compulsory license to a local "third party"
manufacturer to supply a drug for domestic use despite the drug being under
patent. However at Doha it was recognised that countries without
manufacturing capacity would face difficulties in making any use of
compulsory licensing provisions. The WTO has set itself the task of cracking
this problem by the end of the year.
Oxfam and MSF have called for a further Declaration that would expand
TRIPS's article 30, which allows countries to provide limited exceptions to
the rights conferred by a patent. This would permit generic drug
manufacturers to produce drugs solely for export to countries that had
issued a compulsory license. Production for export conditions would be
defined under national law as an exception to the rights of patent holders.
This plan is supported by India and Brazil.
The European Parliament has similarly recently amended a directive issued in
2001 to state that manufacturing should be allowed if the medicinal product
is intended for export to a third country that has issued a compulsory
license for that product, or where a patent is not in force and if there is
a request to that effect of the competent public health authorities of that
third country.
However, the USA has instead proposed that there simply be a long-term
waiver against bringing disputes to the WTO for breach of TRIPs in these
circumstances. However, waivers are inherently unreliable and on this basis
drug firms are unlikely to produce drugs in large supplies.
A third option is a short-term waiver and an amendment to one of the
numerous conditions of a compulsory license prescribed under article 31 of
TRIPs. Article 31(f) requires that any compulsory license authorise the
supply of drugs mainly for the domestic market of the country issuing the
license. The amendment would allow the export of drugs to countries without
a manufacturing base. Critics say that this would continue to make countries
in need of drugs reliant upon the exporting country. Also case-by-case
approval would be necessary, as would the satisfaction of the other
bureaucratic and complex requirements of article 31.
Inside US Trade, a trade newsletter, has reported that the USA had favoured
the exclusion of advanced developing countries from qualifying as importing
countries and had originally advocated that developing countries alone be
eligible as producers.
Whatever option is settled upon, the TRIPs Council must reach a solution
during their meeting in Geneva on Nov 25-27.
Bebe Loff
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Kirsten Myhr, MScPharm, MPH
Head, RELIS Ost Drug Information Centre
Ulleval University Hospital
0407 OSLO, Norway
Tel: +47 23 01 64 11 Fax: +47 23 01 64 10
kirsten.myhr@relis.ulleval.no (w)
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