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Policies & Legislation

European Commission welcomes reduction in ‘potentially problematic’ patent settlements

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

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.

Russian drug spending set to reach US$4 billion by 2020

Russia is planning to pump RUB 120 billion (US$4 billion) into its fledgling pharmaceutical sector this decade as part of a broader push to diversify the economy away from its traditional oil and gas industry.

Danish healthcare spending cuts

In a bid to cut public spending, the Danish government is the latest to announce an austerity package aimed at creating savings of at least DKK 24 billion. The austerity package, as well as slashing unemployment benefits and cutting governmental salaries, also focuses on cost-containment within the healthcare sector.

Austerity measures introduced in Portugal affect generics

Portugal has introduced new measures, published in Portugal’s official journal, Diário da República, which aim to increase domestic access to medicines, stimulate the uptake of generics and make the reimbursement system more efficient. However, both the generic medicines and R & D-based industry have criticised the measures.

Italian austerity measures include generic price cuts

The Italian government has joined many other European countries in introducing measures to slash public spending. Italy’s government has approved a Euros 24 billion austerity package aimed at reducing the national budget deficit – which last year was 5.3% of its gross domestic product – to within the euro-zone limit of 3% by 2012. Cuts aimed at generic medicines are also included amongst these measures.

The preference policy in The Netherlands

The Netherlands is threatening its generic manufacturing industry with its preference policy, according to Mr Frank Bongers, Chairman of Bond Van De Generieke Geneesmiddelenindustrie Nederland (Bogin) – the Association of the Dutch Generic Medicines Industry, and member of the Executive Committee of the European Generic Medicines Association.

Obama refuses to put US healthcare reform on the shelf

As reported by Scrip, US President Mr Barack Obama made clear that he is continuing to push for sweeping changes in the US healthcare system that would extend coverage of tens of millions of Americans who are now uninsured, as he pointed out in his eagerly awaited US State of the Union speech to a joint session of Congress the night of 27 January 2010.

Japan wants to stimulate generics and biosimilars

As reported by Ian Haydock in Scrip News of 19 January 2010, the debate over reforms to Japan's drug reimbursement pricing system is continuing to inch ahead, with signs emerging that the changes could be a double-edged sword for the industry.

FTC Chairman and US Congress members call for US legislation to end ‘pay-for-delay’ deals

On 13 January 2010, US Federal Trade Commission (FTC) Chairman Jon Leibowitz and key members of US Congress, including Representative Chris Van Hollen, Chairman Bobby Rush, and Representative Mary Jo Kilroy, renewed their call for US legislation that would put an end to anticompetitive patent settlements, which drug manufacturers have been using to keep less-expensive medicines off the market and charge consumers billions of dollars a year in higher drug prices.