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Policies & Legislation

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Slow progress towards biosimilar approval in US

Home/Policies & Legislation | Posted 25/02/2011

Although the Biologics Price Competition Act was passed in 2009, progress has been slow in setting up a route by which companies can apply to license biosimilars in the US.

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Exclusivity for biological drugs in the US: what now

Home/Policies & Legislation | Posted 25/02/2011

Drugmakers have been embroiled in an epic battle over the length of the exclusivity period that biological drugs can enjoy before generic competition. Everyone from legislators to senators to health insurers—and of course both branded and generic manufacturers—has ‘weighed in’ on the debate.

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EU patent with 23 countries

Home/Policies & Legislation | Posted 25/02/2011

The patent deadlock may yet be over, as 23 members of the EU have decided to leave behind the four others and work together to create a single patent system to protect the design of products sold across their borders.

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Twelve-year biologicals exclusivity challenged

Home/Policies & Legislation | Posted 11/02/2011

US Californian Democrat Mr Henry Waxman at the World Generic Medicines Congress Americas 2010 challenged the 12-year exclusivity period for originator biologicals.

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Speculation that Hungary will slash drug reimbursement

Home/Policies & Legislation | Posted 04/02/2011

Hungary will next month announce economic reforms and there are fears that they could include cuts of about 30% to the national drug reimbursement bill. The size of this proposed figure implies massive changes in the Hungarian drug market.

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Scottish government considering generic substitution

Home/Policies & Legislation | Posted 31/01/2011

A Scottish politician revealed on 17 November 2010 that the Scottish government is currently considering whether to introduce generic substitution as part of ongoing efforts to reduce spending over the coming years.

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China’s healthcare reform in 2010

Home/Policies & Legislation | Posted 07/01/2011

In April 2009, the Chinese government announced guidelines for healthcare reform. The main goal was to provide universal health care to the country’s 1.3 billion residents. China planned to invest US$125 billion on health care between 2009 and 2011.

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New medicines face big price cuts in Germany

Home/Policies & Legislation | Posted 14/01/2011

The pharmaceutical industry in Germany is facing price cuts expected to cost the industry more than Euros 2 billion per year, where parliament is set to approve the first price controls on newly approved innovator medicines. The law gives drugmakers one year to agree a price with insurers after new drugs are introduced, but if an agreement is not reached, the German Health Ministry will set maximum pricing and the product will undergo a cost-benefit analysis.

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India to delink marketing authorisation and patent status

Home/Policies & Legislation | Posted 07/01/2011

Marketing approvals for generic drugs may soon be delinked from their patent status in India. This comes as a result of long-standing demand from India’s pharmaceutical industry, which depends heavily on the sale of generic drugs.

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Prescription for economic health. Greece acts to reduce expenditure on drugs and counter the culture of corruption

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

Although its economic situation appeared to stabilise in the spring of 2010, Greece has now dived into the red again. This is the first such development to have occurred so far in the euro zone and reflects the enormous economic upheaval the country is going through. The combination of economic decline and healthcare reforms, particularly to the implementation of large drug price reductions suggest an 8.3% decline in drug expenditure for 2010. The government sees the industry as a politically viable target for cost reductions; the cost of drugs had been pushing up healthcare costs from 2004–2009.

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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.