The preliminary check would consider whether national trade-intellectual property rights would negatively impact on access to medicine. This phase is intended to provisionally assess the impact of intellectual property rights law and policy in question on access to medicines according to the right to health’s analytical framework and duties. The first step would be to scan applicable human rights law beyond ICESCR, including other international and regional treaties, and national law and case-law. Second, the implemented or proposed policy should be assessed according to the analytical framework of the right to health, with impact considered along the axes of the availability, accessibility, acceptability and quality of medicines, asking in each instance how the policy or law might enhance or jeopardize these aspects. A similar exercise should be done as against the state’s right to health duties, with relevant duties specified at the outset, supplemented with additional specified duties drawn from national law and cases.

The second step would be to plan the assessment, including who will perform it, identifying social and political stakeholders, issues for investigation, and devising a work plan and timetable setting out these factors.

The third step and the core of the process would be to gather information on the potential right to health impacts of the law/policy looking specifically at law and policy on intellectual property rights and patents, and on health and medicines, health data drawn from secondary sources, consultations with experts and social actors and should also critically include consultations with people likely to be affected by policy. The collection of data should look specifically at key indicators illustrating drug affordability including whether national policy includes the TRIPS flexibilities specified in TRIPS, and confirmed in the Doha Declaration and WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property, including transition periods, parallel imports, experimental use, research exception, compulsory licensing and exclusions? Whether state policy seeks to reduce trade and distribution markups, promote generic substitution policies and encourage pharmaceutical companies to apply differential pricing practices? A key focus should be on assessing the affordability of medicines for the poorest populations as a basic measure of impact. An indicator used by WHO and HAI is to assess how many days wages a lowest paid unskilled government worker would need to pay to buy treatment for common acute and chronic conditions, as well as to ask what percentage of the population live below the international poverty line of $1 per day. Other important information in this regard would be the proportion of household income spent on medicines, the nature of health care coverage, and data illustrating trends in pharmaceutical consumption and public and private pharmaceutical prices. The assessment should also look at information indicating impact on the other grounds, including whether medicines were physically and equally accessible to all, whether there were sufficient quantities of essential medicines in public health care facilities and looking at the availability of resources for health.

Once collected, the assessment could move to the fourth step where data was compared against legal obligations, so as to consider how to improve policy from a right to health perspective, and whether mitigation measures or compensation was necessary? This would engage using spreadsheets that graphically lay out the information as against right to health duties.

The final step would be finalize the report, analyzing impacts on the realization of state duties, health needs and human experience, and making proposals for policy reform, implementation, monitoring and evaluation. Certainly part of monitoring and evaluation might be to construct benchmarks and indicators to measure the extent of progress over the longer term towards the goals of the assessment. This could make the impact assessment an important component of measuring state compliance with the right to medicines more generally.