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Policies & Legislation

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.

Obama wants 10 years or less of biologicals data exclusivity

According to The Associated Press (AP), US President Obama and US House Democrat Henry Waxman have teamed up to make a last-minute push to significantly pare back the 12-year period of data exclusivity lawmakers provided biologicals in the healthcare reform bill. With White House and congressional bargainers moving toward a final health bill, President Obama and Representative Henry Waxman, Chairman of the House Energy and Commerce Committee, are trying to reduce the curbs against competition to 10 years or less.

If they are successful, it would be a major blow to the industry's leading lobbyists at the Biotechnology Industry Organization (BIO) as well as the Pharmaceutical Research and Manufacturers of America (PhRMA), who have managed to hold together a large coalition of US Democrats and Republicans in favour of the long stretch of protection from generic competition.

Data exclusivity is not the same as market exclusivity

Gene Quinn distinguishes facts from fiction on biosimilars on IPWatchdog.com.

According to him, data exclusivity is not the same as market exclusivity. “During a period of data exclusivity, a competitor would be unable to piggyback on the massive investment in R & D made by an innovator to receive approval from the FDA for their ‘copy-cat’ product. Simply put, during the period of exclusivity the FDA may not rely on an innovator’s safety and efficacy data to approve a competitor’s product. Market exclusivity is an altogether different thing – it is the inability of any competitor to enter a specific market. Market exclusivity for biological products would mean that there could be, for example, just one drug to treat leukaemia, one drug to treat diabetes, one drug to treat MS. “This is not the case”, he stresses. “At any moment, hundreds of biotech companies are racing to develop the next wonder drug for any one of these diseases. That situation will not change because of data exclusivity periods. There will continue to be competition among innovative biological products regardless of a data exclusivity period enacted as part of biosimilars legislation”.

According to Mr Quinn, providing innovators with data exclusivity enables them to recoup the investments they made into developing new products and testing product safety and efficacy. “This allows them to continue to invest in new breakthrough medicines, therapies and cures for diseases such as cancer, HIV/Aids and ALS. Competitors are free at any time to conduct their own costly research and development, including clinical trials, and create their own biologicals”, he argues.

Pfizer and the US Biosimilars Pathway

Both the US House and Senate healthcare bills include language that would allow US regulators to set up a method for approving copies of biotechnology drugs. Under the proposals, biologicals would get 12 years of market exclusivity before copies could enter the market. Both US chambers must agree on final language in their overhaul measures.

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