The international medical humanitarian organization Médecins Sans Frontières (MSF) is concerned that a little-discussed provision in the proposed U.S. domestic health care legislation sets data exclusivity standards for biologics that will further hamper access to vaccines and drugs, in addition to setting a dangerous worldwide precedent.
The proposed legislation would provide extended monopoly protections for biologics, a group of therapeutic products that hold great promise for the future and that include vaccines and medicines created by biological rather than chemical processes. This would allow originator companies to extend existing barriers to competition, preventing the development of similar but more affordable products by other manufacturers.
Experience from AIDS medicines has shown how critical competition is to reducing prices and improving access. Thanks to generic competition, the most commonly used combination of AIDS drugs used in developing countries now costs US$80 per patient per year – 99% less than ten years ago.
Drug regulatory authorities rely on the test data of the originator drug or vaccine for the approval of similar products. This has allowed more rapid entry of competitor products into the market – without compromising on safety, efficacy, or quality. Yet extremely restrictive provisions in the proposed U.S. legislation include 12-14 years of data exclusivity for biologics, and provisions that would allow companies to further extend this period almost indefinitely, by making trivial modifications to medicines.
During the data exclusivity period, if another company wants to register a similar version of a drug or a vaccine, it has to generate and submit its own test data. The associated cost and time delays act as a strong disincentive to price-lowering competition. Data exclusivity therefore creates a new patent-like barrier to access to medicines and vaccines, even when these products are not protected by a patent.
As data exclusivity rules can lead to duplicating clinical trials, humans are subjected to risks in order to establish something that is already known. This violates the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human subjects.
The proposed legislation needs urgent revision.
MSF is also concerned that increasingly stringent data exclusivity rules in the U.S. will be used to further increase existing pressure on developing countries, through free trade agreements and by pharmaceutical companies, to either adopt data exclusivity rules or extend data exclusivity periods in countries where these have already been adopted.
Crucially, there is no obligation in the World Trade Organization TRIPS Agreement for countries to provide this protection. Developing countries should remain vigilant about attempts to introduce data exclusivity rules or extend existing rules during bilateral free trade agreement negotiations or under pharmaceutical industry pressure.