Policies & Legislation

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?

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.

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.

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.

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.

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.

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.

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.

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.

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.