Access to medicines and pharmaceutical patents
In brief: In 1997, the South African government enacted legislation to override pharmaceutical patent rights where certain medicines were too expensive or not meeting demand. Recently, while recognising the importance of intellectual property protection, the WTO has declared its support of every country's rights to protect public health and promote access to medicines for all. However, on 20 February 2003, a draft resolution to allow developing countries access to generic pharmaceuticals to address public health problems was rejected. Allens Lawyer Kate Beattie reports..
- Intellectual property rights and public health
- Developing countries and compulsory licences – the draft solution
- Negotiations to date
The World Trade Organisation (WTO) has, so far, failed to find a solution to the problems faced by developing countries in obtaining access to low-priced medicines.
Intellectual property rights and public health
The WTO Agreement on Trade Related Aspects of Intellectual Property (TRIPS) sets out minimum standards for the protection of intellectual property rights by all WTO member countries. TRIPS aspires to promote 'technological innovation … to the mutual advantage of producers and users…' (Article 7).
The WTO Ministerial Conference at Doha (2001) declared that TRIPS is flexible enough to 'promote access to medicines for all' and does not prevent countries from taking measures to protect public health (the Declaration on TRIPS and Public Health, 14 November 2001 (the Doha Declaration)). Under the compulsory licensing provisions of TRIPS, a government, or third party authorised by the government, may in certain circumstances exploit the subject matter of a patent without the authorisation of the patent holder. In the case of pharmaceuticals, for example, a compulsory licence enables a generic pharmaceutical manufacturer to legally manufacture a generic equivalent of a patented pharmaceutical without the authorisation of the patentee.
A compulsory licence may be granted 'predominantly for the supply of the domestic market' only (Article 31(f)). This gives rise to difficulties if the country granting the compulsory licence has no manufacturing capacity in the pharmaceutical sector. That country may, in accordance with TRIPS, grant a compulsory licence to import and distribute a generic pharmaceutical to supply the domestic market. However, a compulsory licence to manufacture that generic pharmaceutical could not be issued in another country (with the relevant pharmaceutical manufacturing capacity), as the licence would not be for 'supply of the domestic market'. Any unauthorised manufacture of that generic pharmaceutical in another country would, therefore, be likely to infringe patent rights in that country.
Developing countries and compulsory licences – the draft solution
It remains to be seen how developing countries that lack the capacity to manufacture pharmaceuticals can make use of the compulsory licensing provisions under TRIPS to obtain access to low-priced medicines to protect public health. The TRIPS Council was asked to report to the WTO General Council before the end of 2002 on an 'expeditious solution' to this problem.
In a draft solution (16 December 2002) the TRIPS Council agreed, in relation to the manufacture of certain pharmaceutical products for export to specified countries, to waive the requirement that a compulsory licence may be granted to supply the domestic market only. This waiver would allow developed countries to grant compulsory licences to manufacture certain generic pharmaceuticals with a view to supplying those pharmaceuticals to developing countries without pharmaceutical manufacturing capacity.
The outstanding issue is the scope of this waiver. Under the draft solution, the waiver would apply in relation to pharmaceutical products needed to address 'public health problems afflicting developing countries', especially those resulting from HIV/AIDS, malaria, tuberculosis and other epidemics. The United States of America considered that the scope of this waiver could fundamentally undermine patent rights for a large range of pharmaceutical products. It is reported that the Unites States of America supported such a waiver in relation to pharmaceutical products needed to address HIV/AIDS, malaria, tuberculosis and similar infectious diseases only.
The European Commission has suggested that the World Health Organisation could determine whether the waiver should apply in relation to a particular public health problem. India and a number of other delegations have indicated that they are not prepared to limit the waiver as proposed by the United States of America.
Negotiations to date
The TRIPS Council has requested more time to reach a solution. The General Council meeting, planned for 11 February 2003, was postponed and has not yet been rescheduled. However, the TRIPS Council meeting on 18 to 20 February again failed to reach an agreement on how widely the waiver should apply.
All countries agreed, in principle, that, in circumstances of national health emergencies, developed countries should be allowed to grant compulsory licences to manufacture generic pharmaceuticals for export to countries which lack pharmaceutical manufacturing capacity (waiving the TRIPS requirement that a compulsory licence may be granted to supply the domestic market only). However, there is no agreement on the appropriate definition of health emergency and, without this, the compromise to date will have no legal effect.
For further information, please contact:
- Dr Trevor DaviesPartner, Allens Arthur Robinson Patent & Trade Marks Attorneys,
Sydney
Ph: +61 2 9230 4007
Trevor.Davies@aar.com.au
