Policies & Legislation
EMA opens up access to reports on suspected drug side effects
In its commitment to transparency, EMA, on 31 May 2012, opened up access to reports on suspected drug side effects. The database contains reports on around 650 medications and active ingredients, including vaccines. Each entry covers a different drug, with aggregated information on suspected but not proven side effects, also known as adverse drug reactions. The database currently holds information on products that have been authorised within the European Economic Area (EEA) via the centralised authorisation procedure which are managed by EMA. Nationally authorised products will feature in a second wave of access in 2013.
US Senator calls for prizes not patents for drug discovery
A radical idea has been proposed by a US Senator calling for patents on drugs to be scrapped and instead an annual prize fund set up, which would reward the discovery of new treatments. These treatments would then, due to competition, become available at the lowest possible price.
Australia cuts prices of 13 more drugs on PBS
Thirteen medicines on the Pharmaceutical Benefits Scheme (PBS), accounting for more than 200 brands, will take price cuts of between 11% and 77% from 1 August 2012 as part of the ongoing price disclosure system agreed between Medicines Australia and the Australian Government.
Bill introduced to allow generics to change labelling
A new bill aims to address a recent Supreme Court decision that threatens to undermine the safety of consumers taking generic drugs.
PhRMA speaks out against compulsory licensing in India
The decision by the Indian government to issue a compulsory licence for the first time has led the research-based pharmaceutical industry to raise concerns regarding research and innovation.
Obama healthcare budget cuts
US President Barack Obama has announced proposals for fiscal year 2013 which aim to cut the US deficit by US$4 trillion over the next decade. However, drugmakers have reacted with disappointment to proposed cuts to health care.
EMA a step closer to implementing new pharmacovigilance rules
In an attempt to enable better protection of public health, new pharmacovigilance legislation was adopted by the European Parliament and European Council in December 2010 [1]. It is now the job of EMA to implement this new legislation, which must be in place by July 2012.
Australia’s biggest-ever generics price cuts coming in April 2012
On 1 April 2012, the prices of 75 medicines supplied through Australia’s Pharmaceutical Benefits Scheme (PBS) will be reduced by an average of 28.7%, saving the government an estimated Australian dollars (A$) 1.9 billion (Euros 1.5 billion) over four years.
Landmark EU ruling on supplementary protection certificates
Pharmaceutical industry groups have broadly welcomed a landmark ruling by the Court of Justice of the European Union (CJEU) clarifying the rules on extended patent protection for multi-disease products. It clarifies the scope of protection afforded by supplementary protection certificates (SPCs) and the circumstances under which they can be granted. The ruling answers questions referred by the Court of Appeal of England and Wales in the cases of Medeva (a company bought by Celltech that, in turn, was taken over by Belgium’s UCB in 2004) and Georgetown University, USA.
Twenty per cent of generic drug user fees to come from API manufacturers
In a presentation by the European Fine Chemicals Group (EFCG) at CPhI Worldwide, Frankfurt, Germany, on 25 October 2011, data was presented showing that generic active pharmaceutical ingredient (API) manufacturers are expected to contribute only a small proportion towards generic drug user fees.
