DHHS Listening Session on WHA 2018: Comment on Agenda item 11.5 Addressing the global shortage of, and access to, medicines and vaccines

On Friday May 11, 2018, the Department of Health and Human Services (DHHS) held its annual listening session in advance of the upcoming World Health Assembly. Comments were limited to 2 minutes, with no time set aside for a question and answer session. On behalf of KEI, I offered this intervention on the topic of transparency:

Comment on Agenda item 11.5 Addressing the global shortage of, and access to, medicines and vaccines Documents A71/12 and EB142/2018/REC/1, decision EB142(3)

My name is Andrew Goldman, I work with Knowledge Ecology International, an NGO that works on intellectual property issues including those that impact drug pricing.

High drug prices are a critical concern both in the United States and around the world, and the United States should be actively seeking to facilitate legal measures that would reduce drug prices, rather than obstruct positive developments at the WHO.

Transparency regarding the costs of research and development would be a good place to start.

There is a consequential asymmetry of information on drug pricing that is toxic for governments and payors trying to formulate policies and evaluate prices.

The pharmaceutical and biotech industries cite high costs of developing new drugs and medical technologies as the primary justification for excessive prices. We agree — this is the only reason why governments grant monopolies that lead to high prices. However, to evaluate how robust and durable the monopoly should be, what constitutes an excessive price, or what alternatives might exist to stimulate innovation, we need more than a simple narrative; we need objective and reliable data.

Key to a more informed discussion will be reporting of actual R&D costs by clinical trial and by year.

The U.S. should encourage efforts at the WHO to create global norms requiring the disclosure of disaggregated costs of clinical trials per clinical trial, including numbers of patients per trial; and any tax credits, grants or other subsidies from public funds that helped pay for the R&D of every drug, vaccine and new gene or cell-based treatment.

The discussion on this issue is well underway at the WHO, and is also well underway here in the U.S., with dozens of states advancing bills that attempt to pull the curtain back on the proffered logic behind high drug prices, as well as several bills before Congress.

The U.S. should also encourage efforts that would improve transparency specific to the complex manufacturing process of biologic drugs, which include some of the most expensive cancer treatments on the market. One of the challenges of creating more affordable biosimilars — and thus one of the reasons why there are only nine biosimilars approved by the FDA to date — is the secrecy regarding the know-how required for manufacturing.

The U.S. should encourage efforts to require that the originator disclose and provide those materials and know-how as a condition of registration of the biologic, in order to expedite the development of biosimilars where the patent is not at issue.