Policies & Legislation

Potential pitfalls in entering China's generics market

Home/Policies & Legislation | Posted 31/08/2009

China's fast-growing pharmaceuticals market is proving attractive to many foreign pharmaceutical firms, including those in the generics sector. Such companies need to be aware of potential pitfalls, some of which were outlined in Scrip News by Mr Jason Wang, Senior Business Development Manager at GreenPine (Tianjin) Pharmaceutical Co, a company that specialises in the registration and distribution of imported pharmaceuticals in China.

New Zealand expects big savings with generic quetiapine

Home/Policies & Legislation | Posted 17/09/2010

The New Zealand pharmaceutical management agency, PHARMAC, expects to save NZ$24 million (US$17.1 million) over the next five years following price reductions for certain antipsychotic drugs. The agency intends to use the savings to fund other medicines.

Battle over ‘pay-for-delay’ deals continues

Home/Policies & Legislation | Posted 17/09/2010

The US Federal Trade Commission (FTC) Chairman, Mr Jon Leibowitz, has been arguing for some months now that passing legislation to restrict pay-for-delay deals between brand name and generic drugmakers will save US consumers billions of dollars. However, a new report throws doubt on the figures used to estimate these savings.

US healthcare reform

Home/Policies & Legislation | Posted 03/09/2010

The tide is finally changing in the US with reform of the healthcare system finally set to provide universal health care to most of the US population. This is great news for the American citizen, but what are the implications for generics and biosimilars in this changing environment?

Indian government encourages biosimilars

Home/Policies & Legislation | Posted 03/09/2010

India has, by far, demonstrated the greatest acceptance of biosimilars. In recent years over 50 biopharmaceutical products have been approved for marketing in India, with more than half of them being biosimilars.

US bill to curb generic ‘pay-for-delay’ deals

Home/Policies & Legislation | Posted 10/08/2010

US drugmakers reacted with anger on 2 July 2010, as the House of Representatives voted in favour of measures to severely curb ‘pay-for-delay’ deals between brand name and generic firms, which have been included, bizarrely, in the War Funding Bill.

Spanish government introduces harsh generic price cuts

Home/Policies & Legislation | Posted 04/06/2010

There has been a sustained slowdown in the Spanish economy since 2008. This has been aggravated by the major international financial crisis, resulting in a decrease in the Spanish Gross Domestic Product (GDP) of 3.6% in 2009. The government has therefore introduced measures to decrease the budget deficit, which include reduction of expenditure by the National Health System.

Spanish government urged to increase generics volume

Home/Policies & Legislation | Posted 04/06/2010

In response to recent stringent price-cutting measures introduced in Spain, the Director General of the European Generic Medicines Association (EGA), Mr Greg Perry, has written to the Spanish Minister for Health and Social Policy. He is concerned about the effect these “overly-harsh price cuts” may have on the economic sustainability of AESEG´s (the Spanish Generic Medicines Association) member companies.

European Commission welcomes reduction in ‘potentially problematic’ patent settlements

Home/Policies & Legislation | Posted 13/08/2010

A European Commission (EC) report on the monitoring of patent settlements has found that the number of patent settlements in the pharmaceutical sector that are ‘potentially problematic’ under the EU’s antitrust rules fell to 10% of total patent settlements in the sector in the period July 2008 to December 2009 compared with 22% in the period covered in last year's inquiry (January 2000–June 2008).

FDA ANDAs containing paragraph IV patent certifications

Home/Policies & Legislation | Posted 09/07/2010

In the US, under the Drug Price Competition and Patent Term Restoration Act, or the Hatch-Waxman Act, a company can seek approval from the FDA to market a generic drug before the expiration of a patent relating to the brand name drug upon which the generic is based. The first company to submit an Abbreviated New Drug Application (ANDA) with the FDA has the exclusive right to market the generic drug for 180 days.