US bill would add six months' protection for biotech drugs

Biosimilars/News | Posted 15/12/2009 post-comment0 Post your comment

A US healthcare reform bill introduced by Senate Majority Leader Harry Reid would extend the protection some brand-name biotech medicines would get from their generic counterparts by six months. An industry executive said this would provide an incentive for companies to make products for children.


Ms Kathleen Jaeger, President of the Generic Pharmaceutical Association (GPhA), said Mr Reid's decision represents “a total hijack” by drug manufacturers that she said will keep consumers' costs higher for a longer time.

“Just when you think the pro-BIO and PhRMA [Pharmaceutical Research and Manufacturers of America] provisions in healthcare reform couldn’t get any more favourable for them, the Senate healthcare reform bill has further disappointed consumers by adding additional monopoly protection to expensive biologic medicines. Regardless of the motivation, the biologic provision in this bill takes the already egregious and unwarranted 12 years of exclusivity and extends it. The Senate leadership had the opportunity to address the deficiencies of the House HCR bill and to fulfil the Senate HELP [Health, Education, Labor and Pensions] Committee’s commitment to close down a major loophole known as ‘evergreening’, and deliver a more reasonable biogenerics pathway to consumers, labour, businesses, generic manufacturers and employers. Instead, they have provided further hurdles to access more affordable medicines. We have strongly urged Congress to put patients over brand company profits by fixing the generic biologics provisions of HCR. Yet, the relentless and powerful brand industry has managed not only to maintain outrageous and excessive product monopolies – but somehow also to increase their profits under the Senate HCR bill. As it stands now, the Senate version not only does nothing to increase timely access, but rather it further delays competition from more affordable generic medicines. It’s an absolute and unequivocal shame that what should be a biogeneric provision designed to expand access to lifesaving medicines and to substantially reduce healthcare costs – a potential ‘HCR game changer’ … benefits only brand companies. In the name of true healthcare reform, it is incumbent upon Congress to strip the anti-consumer biologic provision out of healthcare reform,” Ms Jaeger reacted.

Mr Ken Johnson, a Senior Vice for the PhRMA, said drugmakers pursued the issue with senators and that the extra six months of protection gives companies an incentive to make products for children.

“While we are still reviewing the Senate bill, we remain committed to do our part to make comprehensive healthcare reform a reality this year. We believe that all Americans should have access to high-quality, affordable healthcare coverage and services. If done in a smart way, healthcare reform will benefit patients, the economy and the future of America. Compared to the House bill, which would have a chilling effect on medical progress in America, the Senate approach provides a much better blueprint for reform. If we are going to cure cancer in our lifetime – as President Obama has challenged us to do – we believe any health reform package must support medical progress and innovation in America. Innovative new medicines have dramatically increased life expectancy rates in America and have allowed patients to live longer, healthier and more productive lives and they have also helped bend the cost curve. Fostering continued medical progress should be a key element of healthcare reform.”

Fram A. Reid health bill helps chiropractors, drugmakers. Google/The Associated Press. 2009 Nov 20.

Senate HCR Bill Gratuitously Extends Biologic Monopolies: Lifts Brand Profits to New Heights At Consumer Expense. GPhA Press Release. 2009 Nov 19.

PhRMA Statement on Senate Health Care Reform Bill. PhRMA Press Release. 2009 Nov 19.

Source: Google/The Associated Press; GPhA Press Release; PhRMA Press Release

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