Policies & Legislation

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.

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.

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.

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.