Policies & Legislation

Lundbeck and 4 generics makers fined for pay-for-delay deals

Home/Policies & Legislation | Posted 28/06/2013

The European Commission (EC) announced on 19 June 2013 that it had fined Danish pharmaceutical company Lundbeck and four generics makers for pay-for-delay deals in Europe.

India lists API exporters with written confirmation

Home/Policies & Legislation | Posted 28/06/2013

The Indian drugs regulator has published a list of manufacturers for which it has granted written confirmation that the active pharmaceutical ingredients (APIs) comply with the European Union’s (EU’s) good manufacturing practice (GMP) requirements.

EU lists Japan as having equivalent GMP standards

Home/Policies & Legislation | Posted 21/06/2013

Japan is the latest country to join Australia and Switzerland on the European Union’s (EU’s) list of countries that comply with its good manufacturing practice (GMP) requirements.

US Supreme Court backs FTC in pay-for-delay case

Home/Policies & Legislation | Posted 21/06/2013

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

Home/Policies & Legislation | Posted 14/06/2013

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

Home/Policies & Legislation | Posted 07/06/2013

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

Home/Policies & Legislation | Posted 31/05/2013

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

Home/Policies & Legislation | Posted 31/05/2013

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

Home/Policies & Legislation | Posted 24/05/2013

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

Home/Policies & Legislation | Posted 17/05/2013

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

Home/Policies & Legislation | Posted 10/05/2013

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

Home/Policies & Legislation | Posted 03/05/2013

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

Home/Policies & Legislation | Posted 29/04/2013

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.

Indian high court allows sitagliptin generics

Home/Policies & Legislation | Posted 19/04/2013

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.

Indian Supreme Court rejects Glivec patent

Home/Policies & Legislation | Posted 12/04/2013

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.

US FTC sides with generics makers over drug samples

Home/Policies & Legislation | Posted 05/04/2013

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 makers fight to save pay-for-delay

Home/Policies & Legislation | Posted 29/03/2013

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.

US state biosimilar substitution bill becomes law

Home/Policies & Legislation | Posted 29/03/2013

On 21 March 2013, the US State of Virginia signed into law a legislation allowing for the substitution of biosimilars, but with many restrictions, making it the first US state to introduce such legislation. Brand-name biologicals manufacturers have praised the law as putting patients first, but the generics industry has accused it of pre-empting FDA guidance.

Evergreening patents may make drugs too costly for patients in Thailand

Home/Policies & Legislation | Posted 22/03/2013

Many medicines will become too expensive for patients in Thailand in the near future if the government allows manufacturers to extend patents under the so-called ‘evergreen system’.