Increased access to taxpayer-funded research in US
New legislation demanded by University of Colorado leaders would require that taxpayer-funded manuscripts be made available to the public online at no cost and within six months of the article being published in a peer-reviewed journal.

The legislation would expand the US National Institutes of Health (NIH) public access policy―which already guarantees that research funded by the NIH is accessible by the public―to additional agencies including departments of defence, agriculture, education, commerce, health and human services, homeland security and transportation. It would also apply to the Environmental Protection Agency, NASA and the National Science Foundation.

Source: DailyCamera

UK’s MHRA launches new anti-counterfeiting strategy
On 1 May 2012, UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced the launch of its second anti-counterfeiting strategy, the Falsified Medical Products Strategy 2012–2015.

MHRA also revealed that over the last five years it has seized more than GBP 25 million of counterfeit and stolen medicines, which has no doubt contributed to a marked reduction in known incidents of counterfeit medical products entering the regulated UK supply chain.

Source: MHRA

A small change in FDA policy could stop delays in generics competition
If FDA required drugmakers seeking New Drug Application approval for new formulations or different doses for previously approved molecules to resolve outstanding patent litigation before a new approval is granted it could prevent ‘evergreening’ or delaying of generics competition. That is according to Yale University School of Medicine Professor Harlan Krumholz in an Archives of Internal Medicine article that studied Abbott Laboratories’ tactics with its TriCor (fenofibrate) franchise.

Abbott continually used reformulations, with small changes in doses as a way to thwart competition from generics. As soon as direct competition from generics seemed likely at a new dose level, where substitution would be allowed, Abbott would launch another reformulation, and the cycle would repeat. The small differences in dose of the newer brand-name formulations prevented their substitution with generics of older-generation products. This continued use of the brand-name fenofibrate formulations, which cost twice as much as generic versions of fenofibrate, imposes an annual cost of approximately US$700 million on the US healthcare system, according to Krumholz et al.

Source: Archives of Internal Medicine, FDANews

Sandoz makes deal with Cinpharm for generics in sub-Saharan Africa
Sandoz announced on 23 April 2012 that its German affiliate, 1A Pharma, had signed a deal with Cameroon-owned generics maker Cinpharm for the production of high quality medicines for the sub-Saharan African region.

The construction of the Cinpharm plant in Cameroon was completed in 2010 with support from the German development finance institution, Deutsche Investitions und Entwicklungsgesellschaft (DEG), which finances private sector investments in developing countries. DEG also helped initiate and facilitate this partnership with Sandoz.

Source: Sandoz

Poland breaking EU law by allowing unauthorised generics
The European Court of Justice ruled on 29 March 2012 that Polish legislation authorising the placing on the market of foreign medicinal products lacking authorisation which are cheaper than, but similar to, those already authorised is contrary to EU law.

Poland had argued that importing cheaper medicinal products which had not been authorised by EMA may be justified by financial considerations, i.e. in order to ensure the financial stability of the national social security system and to allow patients who have only limited financial means to have access to the treatment which they need.

Source: Curia