But the legislation spearheaded by Obama, called the Patient Protection and Affordable Care Act (PPACA) could still be derailed if he is not re-elected in November’s Presidential polls. Republican Presidential candidate Mitt Romney has gone on record to promise that his first action if elected President would be to repeal the law. Opponents of the Act say that the Act will raise taxes, increase the US deficit and cause 20 million Americans to lose their existing insurance.
The Act is crucial to the fortunes of biopharmaceutical companies in India, who stand to gain from one of the Act’s sub legislations, titled the Biologics Price Competition and Innovation Act (BPCIA). This section recognises an abbreviated approval pathway for biological products that can be shown to be “biosimilar” to or “interchangeable” with an existing FDA-licensed biological product. Essentially, this sub section would allow Indian biosimilars to enjoy the same status as small molecule generics of off patent drugs made by pharma companies in India.
The close 5-4 ruling on the Act hints that the Act was won by an extremely thin margin. It promises to stay a top, if not the top, election issue, so nothing is certain till the US presidential polls are done. Biopharma players in India, and indeed the rest of the world, will no doubt continue to track the issue and keep their fingers crossed that Obama is re-elected and the Act remains.
Viveka Roychowdhury
Editor