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Policies & Legislation

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Australian healthcare reform

Home/Policies & Legislation | Posted 17/12/2010

Australia’s health expenditure totalled Euros 58.6 billion, representing 9.1% of gross domestic product (GDP) in the financial year of 2007–2008, which is the same percentage of GDP as the previous year. Australia’s health expenditure as a proportion of GDP has been comparable to that seen in Europe, with most of its spending coming from the government.

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EGA publishes vision for more efficient regulation of generics and biosimilars

Home/Policies & Legislation | Posted 03/12/2010

On 27 October 2010 the European Generic medicines Association (EGA) published its Vision 2015 following the official launch of the document at the Heads of Medicines Agencies meeting in Antwerp, Belgium, 26 October 2010. The EGA is calling for changes in the regulatory requirements for generic and biosimilar medicines ‘for the sake of healthcare sustainability’.

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EU patents limp forward

Home/Policies & Legislation | Posted 12/11/2010

The Belgian EU Presidency is trying to break the deadlock over proposals for a single EU-wide patent system, which has been blocked for over a decade due to language issues.

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UK scraps generic substitution plans

Home/Policies & Legislation | Posted 08/11/2010

The UK government has announced that it will not progress with plans to automatically substitute medications with generic drugs in primary care. Health Minister Lord Howe announced the decision on 14 October 2010, following a public consultation, which showed that many people thought it posed a risk to the safety of patients and could create more work for National Health Service (NHS) staff.

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WHO prequalification programme for medicines

Home/Policies & Legislation | Posted 20/10/2010

Today, one third of the world’s population lacks access to essential medicines. In the poorest parts of Africa and Asia this figure rises to a half of the population.

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Price cuts, legislation and reforms

Home/Policies & Legislation | Posted 24/09/2010

In an effort to reduce budgets governments across the globe are lining up price cuts in prescription medicines, new legislation to control medicine prices and reforms in the healthcare systems. The question is how will all these changes affect the generic medicines industry and is it just a short-term fix?

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Pharmacovigilance legislation moves a step closer

Home/Policies & Legislation | Posted 24/09/2010

In the European Parliament’s plenary session in Strasbourg on 22 September 2010, Members of European Parliaments voted by a huge majority (559 to 7) to adopt new pharmacovigilance legislation. The new EU law should provide better protection for people with medical conditions and make them better informed about the use and any undesirable side effects of medicines.

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China set to give a big boost to biologics

Home/Policies & Legislation | Posted 24/09/2010

According to a report in a Chinese newspaper, China is planning to spend more than CNY 10 billion (US$1.5 billion) to support the development of new drugs between 2011 and 2016. Biotechnology was identified as one of seven emerging industries that China will use to spearhead the next big step in its economic development.

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.

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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.

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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.

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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?

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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.

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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.

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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.

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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.

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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).

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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.

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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.

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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.