TRIPS agreement flexibilities provide opportunities for improved access to ARVs
On 15 March 2011, UNAIDS released a Policy Briefing highlighting the ways in which governments, particularly in developing countries, can use the TRIPS Agreement flexibilities and the subsequent Doha Declaration on the TRIPS Agreement and Public Health to overcome the changes to patent law which will come into effect in developing countries from 1st January 2016. By signing up to the TRIPS agreement, countries are losing their flexibility to authorise patents of varying lengths and are forced to patent all intellectual property rights.
The TRIPS Agreement flexibilities can be used to mitigate the impact on the production of generic drugs such as ARVs. They include:
- Compulsory licenses these are mechanisms whereby governments or other public authorities can authorise the use of patent-protected inventions without the consent of the patent-holder, who will receive compensation royalties. Compulsory licenses can be granted based upon various grounds of interest such as public health as determined by the WTO Member themselves.
- Parallel imports due to various market factors, companies are sometimes able to produce patented medicines at cheaper prices in certain countries. Developing countries can then buy the drugs at lower prices and import them rather than buying from domestic markets and having to pay high prices. Legally a patent can only control the price of sale within the country of manufacture. This means an intermediary could buy patented drugs in one country at a cheaper rate, import them to another country at a slightly higher price whilst still undercutting the domestic manufacturer. This is called parallel importing.
- Bolar provision/regular exception – this is a mechanism whereby a patented product can be used without authorisation to obtain the generic marketing approval prior to patent expiry. This enables generic products to enter the market immediately after patent expiry.
- Exemptions for least developed countries in November 2005 the WTO TRIPS Council extended the time at which least developed countries are mandated to comply with the TRIPS Agreement to 1st January 2016. This is subject to further extension upon request (Article 66.1 TRIPS Agreement)
The Doha Agreement states that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members right to protect public health and, in particular, to promote access to medicines for all.
Several countries have begun to use the flexibilities outlined above to ensure access to cheaper generic ARVs. In 2006-2007 Thailand issued a compulsory license for efavirenz and lopinavir/ritonavir. This resulted in a tripling of the number of people using lopinavir/ritonavir despite outrage by multinational drug companies.
To enable countries which are already WTO Members to make use of the opportunities provided by TRIPS flexibilities, it is a pre-condition that they must first amend their national patent laws to incorporate the flexibilities. In 2007 a UNDP study showed that only 6 countries had incorporated the flexibilities into their legislation. A more recent study by WIPO on 142 countries revealed a vast disparity in the levels of inclusion of the TRIPS Agreement flexibilities both between countries and with regards to the different types of flexibility. For example of 112 countries with the information available, only 36 (32%) had laws allowing for with regards to parallel imports. Without these national legislative amendments, the TRIPS Agreement flexibilities will not be available for use, which in turn limits the opportunities for access to cheaper ARVs.
WIPO study report, Patent Related Flexibilities in the Multilateral Legal Framework and their Legislative Implementation at the National and Regional Levels: