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ESMO Press statement - European Commission proposal would streamline patient access to medicines

ESMO welcomes the recent EC proposal which will facilitate patient access to innovative treatments on an EU-wide level
12 Mar 2012
Bioethics, legal and economic issues

The European Society for Medical Oncology (ESMO) welcomes the recent proposal by the European Commission aimed at streamlining the process and shortening the timeline surrounding national decisions on pricing drugs and reimbursement of payment made for medicines. This initiative, says ESMO, will facilitate patient access to innovative treatments on an EU-wide level.

“The proposed directive supports ESMO's constant endeavour to guarantee that cancer patients can access optimal treatment, including the opportunity to obtain innovative drugs, which have become a decisive tool for improved outcome in cancer care,” said ESMO spokesperson Prof Christoph Zielinski, Head of the Oncology department of the University Hospital in Vienna, Austria.

According to the proposal made by Antonio Tajani, the European Commission Vice President responsible for Industry and Entrepreneurship, the new procedure will allow faster access to drugs by streamlining reimbursement decisions and pricing strategies in individual EU Member States.
The current European Commission initiative is resulting from the Pharmaceutical Sector Inquiry from 2009 which revealed long and disharmonized processes resulting in different pricing and reimbursement decisions in the various EU Member States, thus generating unequal access opportunities to various groups of drugs between individual states of the European Union. “Hopefully the old times when up to 700 days were needed for approval of innovative medicines and 250 for generics will soon be over,” said Zielinski.

According to the new proposal, national decisions should be taken within 120 days for novel medicines and within 30 days for generic medicinal products. The new Directive shall repeal and replace the longstanding Transparency Directive from 1989, which did not anticipate the increased complexity of pricing and reimbursement procedures in the Member States.

“The proposal also represents the logical consequence of the dynamic growth of knowledge translated into the advent of innovative pharmaceutical compounds. The desire to streamline patient access to innovative drugs on EU level can and should be combined with a dynamic and solid pharmaceutical market, hopefully resulting in vigorous R&D activity for the benefit of patients,” Zielinski added.

“Amelioration in access to innovative drugs is most welcomed, because these are recognized as potentially decisive to guarantee state-of-the-art treatment in today’s oncology setting,” the ESMO spokesperson highlighted. Additionally, a common regulation of the duration of decision-making processes on drug pricing and reimbursement should favourably influence the economic framework of the pharmaceutical drug market.
“ESMO welcomes this initiative as a sign of appreciation of shared endeavours to guarantee that European cancer patients can access important drugs under the most favourable conditions.”

The European Medicines Agency has recently published a list of all new human medicines under current evaluation by the Committee for Medicinal Products for Human Use (CHMP). The current list includes more than 20 antineoplastic medicines, generic and biosimilar medicinal products as well as orphan drugs for the oncology field. “These drugs are in fact the result of complex and expensive clinical research that ESMO itself promotes and supports through continuous strong commitment in educating medical oncologists. If we can really count on more prompt availability of these important research results, we will get closer to accomplish our mission for the ultimate benefit of our patients.”


  1. Details about the European Commission proposal are available at http://ec.europa.eu/enterprise/sectors/healthcare/competitiveness/pricing-reimbursement/transparency/index_en.htm
  2. The list of human medicines currently under evaluation by the European Medicines Agency is available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_001457.jsp&mid=WC0b01ac058004d5c1
Last update: 12 Mar 2012

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