Policies & Legislation

Most of the Commonwealth of Independent States (CIS) countries do not have modern drug reimbursement policies. However, recently Kazakhstan, Russia and Ukraine have all taken steps to improve their drug policies and introduce drug reimbursement schemes similar to those employed in other countries.

The Australian Government announced on 5 May 2013 a major review into the way chemotherapy drugs are funded.

FDA has informed generics and active pharmaceutical ingredient (API) manufacturers that they will have one month to self-identify for the generics drug user fees for fiscal year (FY) 2014.

EMA published a concept paper on extrapolation of efficacy and safety in drug development in April 2013. The publication of the concept paper comes at a time when extrapolation for biosimilars is a hot topic.

Maryland has become the fourth US state to reject legislation that could restrict pharmacists’ ability to substitute cheaper biosimilars for their reference biologicals.

The European Union (EU) has introduced new rules for importing active pharmaceutical ingredients (APIs) for human use into Europe; however, two of its biggest suppliers have yet to put systems in place to comply with these new rules.

In the latest development in Merck Sharp and Dohme’s (MSD’s) court case over the patent infringement of its diabetes drugs, an Indian high court has refused to grant interim relief to MSD, thus allowing generics to remain on the Indian market.

On 2 April 2013, the Supreme Court of India rejected drugmaker Novartis’ seven-year battle to patent its cancer drug Glivec (imatinib mesylate), ruling that the drug was not a new invention.

The US Federal Trade Commission (FTC) has come out in support of generics companies trying to get hold of brand-name drugs in order to make generic versions.

Brand-name drug and generics manufacturers are joining forces to fight against the US Federal Trade Commission (FTC) in the case of reverse patent settlements or ‘pay-for-delay’, as the FTC terms these deals.