Policies & Legislation

On 1 April 2012, the prices of 75 medicines supplied through Australia’s Pharmaceutical Benefits Scheme (PBS) will be reduced by an average of 28.7%, saving the government an estimated Australian dollars (A$) 1.9 billion (Euros 1.5 billion) over four years.

Pharmaceutical industry groups have broadly welcomed a landmark ruling by the Court of Justice of the European Union (CJEU) clarifying the rules on extended patent protection for multi-disease products. It clarifies the scope of protection afforded by supplementary protection certificates (SPCs) and the circumstances under which they can be granted. The ruling answers questions referred by the Court of Appeal of England and Wales in the cases of Medeva (a company bought by Celltech that, in turn, was taken over by Belgium’s UCB in 2004) and Georgetown University, USA.

In a presentation by the European Fine Chemicals Group (EFCG) at CPhI Worldwide, Frankfurt, Germany, on 25 October 2011, data was presented showing that generic active pharmaceutical ingredient (API) manufacturers are expected to contribute only a small proportion towards generic drug user fees.

On 16 November 2011, US Senators Mr Jeff Bingaman, Mr David Vitter, Mr Sherrod Brown and Mr Jeff Merkley introduced a bill in the Senate that would remove the 180-day exclusivity period for generics applicants.

A bill banning pay-to-delay, the practice by which originator and generics firms share the profit from drugs coming off patent rather than moving quickly to price reduction, is progressing slowly through the US legislature. It has made its way through the Senate Judiciary Committee but has not yet been approved by the Senate [1]. President Barack Obama has joined in, with a pay-to-delay ban in his 2012 budget proposal [2].

2013 looks set to be another great year for generics and biosimilars, with once again some major blockbuster drugs losing patent protection.

Both EMA and FDA are increasing their requirements for stability testing, especially for generic drugs. These changes could significantly increase the length of time required to gain regulatory approval and increase costs for generics manufacturers to get their drugs onto the market.

The Australian and New Zealand governments have agreed to proceed with a joint scheme for regulation of therapeutic goods, i.e. medicines, medical devices, etc. The creation of a joint regulatory scheme across both countries will safeguard public health and safety, while encouraging economic integration and benefitting industry in both countries.

New pharmacovigilance legislation was adopted by the European Parliament and European Council in December 2010. EMA is the regulatory body responsible for implementing much of the new legislation and is developing a framework for compliance and delivery of key requirements. The legislation will be effective from July 2012.

China has, for the second time this year, cut the price of drugs. The maximum retail price of 82 different pharmaceutical drug types has been lowered by an average 14% in a move to reduce patient’s medical bills.