Policies & Legislation
US Supreme Court backs FTC in pay-for-delay case
On 17 June 2013 the US Supreme Court ruled 5-3 in favour of the Federal Trade Commission (FTC) in the case of FTC versus Actavis with respect to reverse patent settlements or ‘pay-for-delay’, as the FTC terms these deals.
Indian Government moves closer to complying with EU API rules
On 23 May 2013, the Indian Government announced that it had issued finalized guidelines for drugmakers to comply with a European Union (EU) directive on standards for import of active pharmaceutical ingredients (APIs) into the EU that takes effect on 2 July 2013.
EU to fine 9 drugmakers over pay-for-delay deals
The European Commission (EC) is reportedly ready to fine Danish pharmaceutical company Lundbeck and eight generics makers over alleged pay-for-delay deals in Europe.
Ireland passes bill to encourage generics use
On 22 May 2013, the Health (Pricing and Supply of Medical Goods) Bill 2012 was passed by both Houses of the Oireachtas (Irish Parliament).
India introduces new drug pricing control
On 15 May 2013, India’s Directorate of Food and Drugs Administration announced the introduction of a new Drug Price Control Order (DPCO), which is expected to lead to price reductions of up to 80% in ‘essential drugs’.
Kazakhstan, Russia, Ukraine to change drug reimbursement schemes
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.
Australia reviews chemotherapy drug subsidies
The Australian Government announced on 5 May 2013 a major review into the way chemotherapy drugs are funded.
Generics makers to self-identify for FY2014 generics fees
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 publishes concept paper on extrapolation
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.
China and India still to comply with new EU API rules
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.
