Policies & Legislation
FAIR Generics Act could remove 180-day exclusivity
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.
Bill to outlaw pay-to-delay moves ahead slowly
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’s biggest patent expiries
2013 looks set to be another great year for generics and biosimilars, with once again some major blockbuster drugs losing patent protection.
New stability testing rules for generics
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.
Australia and New Zealand outline plans for joint regulatory agency
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.
Practical guidance on new pharmacovigilance legislation
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 cuts drug prices for the second time in 2011
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.
US President approves patent reform
On 16 September 2011, US President Barack Obama signed into law a patent-reform bill that has been backed by brand-name drugmakers but opposed by generics companies.
US Senate approves patent reform
On 8 September 2011, the US Senate passed a patent-reform bill that has been backed by brand-name drugmakers but opposed by generic companies.
European Commission publishes new rules on falsified medicines
A new directive on falsified medicines was published in the Official Journal of the European Union 1 July 2011.
