Law and policy reform

We advocate for change in laws and policies to protect access to medicines and public health


Laws and policies relating to intellectual property affect access to medicines and the health of nations. The impacts can be positive or negative, depending on how the laws are shaped and implemented.

Many developing countries have been urged to use “flexibilities” to protect access to essential medicines, but few have done so effectively.

The World Trade Organization’s TRIPS agreement (Trade-Related Aspects of Intellectual Property) introduced a requirement on countries to grant patents on medicines. The agreement allows countries to take advantage of “flexibilities” to tailor the intellectual property protection to local circumstances and needs.

Many reports and policy guides have described these flexibilities, and urged developing countries to use them to protect their access to essential medicines. There have been some notable successes with countries using the TRIPS flexibilities effectively, but these are the exceptions. In the majority of developing countries, the flexibilities have been little-used, and when used, have been only minimally effective.

Several countries have failed to develop laws and policies that support public health because of:

  • a lack of supportive legal frameworks;
  • resource constraints;
  • limited technical expertise and coordination between the ministries of trade and health;
  • continued unilateral pressure;
  • biased technical assistance from richer countries; and,
  • new free trade agreements.

As a result, many countries, offer intellectual property protection that far exceeds what is required by TRIPS. The consequence is unnecessary higher price of medicines.

What we do

We advocate for the inclusion of these flexibilities and their full use under national laws to protect public health. Adequate and user-friendly regulations should make it straightforward for those who wish to use the flexibilities.

We aim to help governments:

  • Incorporate into domestic law and use the provisions on compulsory and ‘government use’ licensing where necessary, to ensure citizens have access to medicines. These provisions should take full advantage of the flexibilities afforded by TRIPS;
  • Make use of ‘parallel importation’, by allowing imports of patented medicines from other countries where these are cheaper. This is known as adoption of national exhaustion regimes;
  • Adopt explicit limits on the scope of what can be patented, and improve the quality of patents by creating legal frameworks that enable interested parties to oppose and revoke unmerited patents;
  • Sensitize the judiciary to the implications for health and human rights of decisions in the area of IP;
  • Incorporate under national law additional exceptions to patent rights;
  • Develop and use unfair competition laws to curb anti-competitive IP practices, that block access to medicines and public health;
  • Reject TRIPS-Plus obligations that are negotiated separately under Free Trade Agreements and that undermine access to medicines.

Read ‘Access to Medicines: The Role of Intellectual Property Law and Policy’ (PDF) to find out more about this topic.

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