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Policies & Legislation

US bill proposes Comparative-Effectiveness Research Centre

Mr Randall Stafford of the Stanford Prevention Research Center and Mr Caleb Alexander of the University of Chicago, USA have published several challenges that must be met if comparative-effectiveness research (CER) is to be useful in significantly improving the quality and affordability of US health care. In the 17 June 2009 issue of the Journal of the American Medical Association they write, “Researchers, policy makers, insurers, and other stakeholders have voiced enthusiasm about the value of CER that rigorously evaluates two or more drugs or devices. The most recent boost for these efforts has been the US congressional financial stimulus package that contains provisions for US$1.1 billion (Euros 787.4 million) to be devoted to this effort. The appeal of CER is undeniable. If there is one issue that stakeholders agree about, it is that increasing healthcare costs are ultimately unsustainable and society needs more value for its money. However, it is not clear whether CER, as it is commonly framed, has a comparative advantage when it comes to improving the US healthcare system. If CER is to succeed, future initiatives will need to generate data prior to the widespread adoption of a drug or device.”

BIO: Patent gap for biologicals ignored by Federal Trade Commission report

In the US, the outstanding issue surrounding the biosimilars debate remains the exclusivity period before competitors can come on the US market – and the US is no closer to a resolution following the 10 June 2009 report by the Federal Trade Commission (FTC), Emerging Health Care Issues: Follow-on Biologic Drug Competition.

Teva wants new rules for first generic entrants in EU

In Europe first EU generic entrants should be given a period of market exclusivity, Teva Europe President and CEO, Dr Gerard Van Odijk, claimed at the World Generic Medicines Congress Europe 2009 held in London, UK, in February. He said that once a product’s patent expired “everyone jumps on the bandwagon. What we need is an alternative way to continue the appetite to take risks in Europe.”

Regulatory approval of biosimilars in Europe

Biosimilars present a new set of challenges for regulatory authorities compared with conventional small-molecule generics, for which the demonstration of pharmacokinetic similarity to the reference product is sufficient.