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Policies & Legislation

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2012’s biggest patent expiries

Home/Policies & Legislation | Posted 29/04/2011

Once the patent expiries set for 2011 are gone it is not over for the pharmaceutical industry, as 2012 looks set to be another bumper year for generics, with patents from more of the biggest selling drugs set to expire.

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Change in Canadian exclusivity period may harm generics

Home/Policies & Legislation | Posted 29/04/2011

The EU is in negotiations for a comprehensive economic and trade agreement (CETA) with Canada. As part of these negotiations the EU has proposed changes to the length of data exclusivity for originator drugs in Canada to bring them in line with time periods used in the EU.

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2011’s biggest patent expiries

Home/Policies & Legislation | Posted 22/04/2011

2011 looks set to be a bumper year for generics, with patents from some of the biggest selling drugs set to expire.

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Still no word from FDA on generic user fees

Home/Policies & Legislation | Posted 22/04/2011

Well the FDA finally held its long-awaited meeting on generic user fees on 23 February 2011. However, since then there has been no news from the FDA as to when and how these user fees will be implemented, and more importantly how much they will cost and what will the review timelines be?

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European Council gives go-ahead for EU patent – but is it legal

Home/Policies & Legislation | Posted 15/04/2011

The European Council announced that it had given the go-ahead on 10 March 2011 for use of a rarely used provision of the Lisbon Treaty known as ‘enhanced cooperation’ to launch a common EU patent system without Italy and Spain on board.

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Falsified medicines law approved by European Parliament

Home/Policies & Legislation | Posted 01/04/2011

Following many months of negotiations, a new law to prevent fake medicines from entering the supply chain was finally approved by the European Parliament on 16 February 2011. Internet sales will also be covered by the law, which introduces new safety and traceability measures as well as sanctions against counterfeiters. The law, which has been in the pipeline for over two years, still needs to be formally approved by the Council of Ministers.

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Negotiations on generic drug user fees

Home/Policies & Legislation | Posted 25/03/2011

Things seem to be finally moving ahead with the FDA’s long-awaited attempt to create a system of user fees for assessing generic drugs. The US Agency [FDA], which has a backlog of more than 2,000 products to review and has been short of funds for years, will launch negotiations with generic drug manufacturers by the end of February 2011.

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Australian copyright law amended to benefit generic medicines

Home/Policies & Legislation | Posted 18/03/2011

On 22 February 2011 the Australian Senate Legal and Constitutional Committee introduced into Federal Parliament the Therapeutic Goods Legislation Amendment (Copyright) Bill.

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More debate over ‘pay-to-delay’ legislation in the US

Home/Policies & Legislation | Posted 11/03/2011

Two US Senators and now President Barack Obama in his 2012 budget proposal have re-introduced the debate over proposed legislation that would curb—or even ban—‘pay-for-delay’ deals.

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Generic pre-emption: what are the implications

Home/Policies & Legislation | Posted 11/03/2011

Although it has been rejected by several lower courts, generic pre-emption is not yet ‘dead and buried’ as the Supreme Court now takes on the case.

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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.