“We acknowledge the results of the EU-funded GRACE project and in particular the recommendation to dismiss mandatory 90-day rodent feeding studies in GMO risk assessment,” said Beat Späth, Director of agricultural biotechnology at EuropaBio.
The 3rd edition of European Biotech week, an annual initiative that began in 2013 and took place between 12th October and 18th October this year, concluded with more than 100 events and activities involving thousands of Europeans in a record 15 European countries.
The European pharmaceutical industry welcomes the initiative by the European Commission Directorate General for the Internal Market, Industry, Entrepreneurship and SMEs (DG Grow) to host on 6 October 2015, an event on access to biosimilar medicines in Europe.
EuropaBio called on EU decision-makers to implement bold policies to ensure that the European healthcare biotech sector retains its competitiveness on a global scale and continues to deliver growth, jobs and innovation.
Attending a health conference organised by the European Commission in Brussels today, EuropaBio called on EU policy-makers to continue promoting biopharmaceutical innovation, while maintaining high EU standards for the safety and efficacy of medicines.
EFPIA, EUCOPE and EuropaBio are concerned that government initiated off-label use of medicines on economic grounds circumvents the robust EU authorisation process for medicinal products, which sets rigorous standards for market approval for specific medical needs based on the benefit to risk ratio.
Biopharmaceutical companies face high costs of clinical development for regulatory approval against a backdrop of increasingly fragmented reimbursement systems and assessment mechanisms unfit for the specificities of personalised therapies.