World Health Organisation Approves Resolution on Price Transparency
On 28 May 2019, the final plenary of the World Health Assembly (“WHA”), the decision-making body of the World Health Organisation (“WHO”), approved a resolution entitled “Improving the transparency of markets for medicines, vaccines and other health products”. The resolution, originally proposed by Italy, was adopted on the last day of the 72nd WHA, which took place in Geneva from 20 to 28 May 2019. According to WHO officials, this “landmark measure” could have lasting impact on prices in markets for urgently-needed health products, ranging from treatments for cancer and hepatitis, to insulin.
The goal of the resolution is to improve transparency in pharmaceutical markets, from the cost of research and development, including clinical trials, to the prices negotiated by countries and the amount of public funding given. More specifically, the resolution calls on states to “take appropriate measures to publicly share information on the net prices of health products” which it defines as “the amount received by manufacturers after subtraction of all rebates, discounts, and other incentives”. It also asks the WHO’s secretariat to monitor the impact of transparency on access to medicines, including the effect of differential pricing.
Many countries co-sponsored the resolution, including Brazil, Japan, Norway, Spain, Switzerland, Thailand and the United States. Others, however, such as Germany, Hungary and the UK, strongly disagreed with the resolution’s far-reaching implications and disassociated themselves from it on voting day.
In particular, debates took place over the costs relating to research and development. The final language underlines the voluntary nature of the resolution, urging states to “take the necessary steps, as appropriate, to support dissemination of and enhanced availability of and access to aggregated results data and, if already publicly-available or voluntarily-provided, costs from human subject clinical trials regardless of outcomes or whether the results will support an application for marketing approval, while ensuring patient confidentiality”. This version is watered-down from the original text, which did not include the voluntary provision, and instead called on states to provide the cost information as necessary.
The resolution coincides with what would seem to be a general trend towards more price transparency. For example, on 15 May 2019, Beneluxa cited transparency as a “key contributor to achieving sustainability of access to medicines”. Conversely, Poland is reportedly working on legislation that would limit information on negotiations with pharmaceutical companies. Though Poland was part of the consensus to approve the resolution, it initially was against it, since it has been trying to limit making public information on medicine prices.
Pharmaceutical companies and lobby groups disagree about the impact of this resolution on the industry. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) warned that disclosing prices could make it harder for the industry to offer lower prices to poorer countries. The group also raised concerns about how much time was given to the discussions relating to the resolution, a feeling that was shared by the opposing countries, such as Germany. On the other hand, some groups applauded the resolution, seeing it as an essential step to improve universal access to medicines.
The WHA is, as noted, the decision-making body of the WHO and is attended by delegations from all WHO Member States. It focuses on a specific health agenda prepared by the Executive Board. Resolutions, though not legally binding, represent the will of member states and the highest level of commitment. The WHA can also adopt binding decisions, but these need to be presented as a convention or an agreement and require a two-thirds majority.