Policies & Legislation

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.

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

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

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

Home/Policies & Legislation | Posted 18/06/2010

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

Home/Policies & Legislation | Posted 18/06/2010

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

Home/Policies & Legislation | Posted 18/06/2010

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

Home/Policies & Legislation | Posted 18/06/2010

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

Home/Policies & Legislation | Posted 26/02/2010

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

Home/Policies & Legislation | Posted 12/02/2010

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

Home/Policies & Legislation | Posted 10/02/2010

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

Home/Policies & Legislation | Posted 10/02/2010

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

Home/Policies & Legislation | Posted 26/01/2010

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

Home/Policies & Legislation | Posted 22/01/2010

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.

US regulators should catch up with Biosimilars Pathway

Home/Policies & Legislation | Posted 19/01/2010

A proposal by US Democratic Representative Anna Eshoo included in the US House health reform bill, would give developers of innovative biomedical drugs 12 years of data exclusivity from generic competition, significantly extending their patent rights, writes Los Angeles Times columnist Michael Hiltzik.