Anna Eshoo Biosimilars (HR1548) bill has bad provisions on data exclusivity

Congress should reject the 12-14.5 year monopoly for biologic products provided for in HR 1548

KEI* opposes H.R.1548, the bill to “establish a pathway for the licensure of biosimilar biological products,” on the grounds that the period of the monopoly is excessive, and not subject to safeguards that would protect consumers.

HR 1548 conditions market entry for biosimilar products on a 12 to 14.5 year period of legal monopoly for products that is independent of the patent status of products. The putative rationale is to reward investments in new products. However, there is no requirement that the monopoly bear any relationship to the investments in particular products, pricing, or the cumulative revenues generated by the product. The period of exclusivity can extend 9 years beyond that currently exists for pharmaceutical drugs, and presents considerable risks to the public as consumers, taxpayers, employers and subjects of medical experimentation.

The alternative approach supported by Representative Waxman and the White House of providing a 5 to 7 year monopoly is also excessive, but certainly preferred to an approach that provides a 14.5 year monopoly.

KEI agrees with Essential Action and others that believe a bill based upon exclusive rights to rely upon safety and efficacy of products is itself fundamentally flawed, for several reasons, including the fact that it provides economic incentives for unnecessary and unethical clinical testing of products on human subjects. KEI encourages members of Congress to reflect on the provisions of the Declaration of Helsinki on the ethical principles for medical research involving human subjects, including but not limited to Articles 20 and 21, and to consider if other approaches are more appropriate, including those that allow biosimilars to enter into agreements to share the risk adjusted costs of clinical trials./1/

In any case, the grant of a monopoly should not be without limits or safeguards to protect consumers and taxpayers. Any bill that grants a legal monopoly from competition should also include provisions that allow the monopoly to be eliminated if products are priced excessively, or if other factors merit a review of the monopoly status. The bill should also require that companies disclose actual R&D costs, prices and revenues for products, and that that the federal government should have the opportunity to review the provision periodically to determine if the term of the monopoly is excessive, or if there is a need for additional safeguards to protect the public, or if new approaches, such as cost sharing, are more appropriate in the context of a policy to advance health interests.

Knowledge Ecology International
FMI: Judit Rius judit.rius@keionline.org (1.202.332.2670)
James Love james.love@keionline.org (1.202.361.3040)

*Knowledge Ecology International (KEI) is a non-profit organization that focuses on issues about innovation and access to knowledge goods, including new medical inventions.

/1/. See: Judit Rius Sanjuan- James Love – Robert Weissman, PROTECTION OF PHARMACEUTICAL TEST DATA: A POLICY PROPOSAL, 21 November 2006