Two years after World Health Assembly Resolution 72.8 was agreed on improving the transparency of markets for medicines, vaccines and other health products, WHO/Europe has released a report identifying and summarizing the current evidence on the implementation of transparency measures in the WHO European Region. This follows intense debate over the roles and responsibilities of the public and private sectors in the development of vaccines for COVID-19.
The review identified 2 mechanisms in place to improve the transparency of markets – price transparency and greater transparency of research and development costs. The review highlights the importance of transparency, among other recommendations such as price and cost monitoring. It also explains that the public interest should be considered when countries are deciding whether to enter into pricing-related confidentiality agreements with pharmaceutical companies.
The report is part of the Health Evidence Network synthesis report series and was written by researchers from Medicines Law and Policy, based on a scoping review of 50 publications.
High cost of medicines
The high prices of medicines, vaccines and other health products can prevent access to treatments that are critical to care. For governments, the high cost of medicines may risk overburdening health budgets or resulting in inequities among certain population groups.
In some instances, patients may have to pay “out of pocket” for medicines, if they are not covered by existing schemes. The high cost of medicines can lead to financial hardship, which in severe cases is known as catastrophic health spending. The WHO Barcelona Office for Health Systems Financing undertakes regular monitoring of the cost of health care, including out-of-pocket payments.
WHA resolution 72.8
In both the public and private sectors, a lack of transparency over many aspects of the markets for pharmaceuticals, vaccines and health products prevents robust decision-making. Member States have long had concerns that they are not well-equipped to make fully informed decisions when negotiating the purchasing of such products. In 2019, this led to the World Health Assembly passing resolution 72.8, which calls for improved transparency across multiple aspects of the market – including pricing, patent status, clinical trial results, mark-ups and research and development costs.
The report offers policy considerations for Member States when negotiating prices for medicines, vaccines and other medical products, as follows:
- be aware that Member States do not have to enter into confidentiality agreements with pharmaceutical manufacturers if doing so is not in the public interest;
- take steps to implement legislation that ensures transparency of prices across the pharmaceutical supply chain in line with WHO recommendations;
- adapt existing laws and policy mechanisms on the disclosure of prices of medicines;
- implement consistent price regulation, monitoring and reporting;
- enact legislation to improve transparency on research and development investments and costs, drawing on examples of European Union and national legislation;
- review national access to data about prices and costs to ensure informed price negotiations.
Oslo Medicines Initiative
Discussions about the transparency of markets will take place as part of the Oslo Medicines Initiative. Developed by WHO/Europe, the Norwegian Ministry of Health and Care Services and the Norwegian Medicines Agency, the initiative provides a neutral platform for the public and private sectors to jointly outline a vision for equitable and sustainable access to effective, novel, high-cost medicines.