Policies & Legislation

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.

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.

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.

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.

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.