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EU Parliament Committee Adopts Report On Increased Medicines Access In Europe
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The European Parliament Environment, Public Health and Food Safety Committee has voted to adopt a draft report on measures to increase availability of medicines within the European Union, according to sources.
The draft report proposed numerous measures to increase access to medicines, asking the parliament to study the impact that intellectual property protections actually have on promoting innovation and to increase publicly funded research to better address patient need. Direct measures to control the cost of drugs and increase competition were also requested, including regular monitoring of patent settlement agreements which may restrict entry of generics into the market, guaranteeing timely entry of generic and biosimilar drugs, and ending patent linkages.
The report calls upon the European Commission to strictly limit the effects of Supplementary Protection Certificates and data exclusivity or market exclusivity on competition. These certificates extend a patent to compensate for the time spent on clinical trials and testing, and can last for up to 5 years.
The report also calls on the EU Commission and member states to make use of the flexibilities contained in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and “to coordinate and clarify their use when necessary.”
Also proposed by the report is that the Commission examine and compare the prices of medicines in the EU and present an annual report to the Parliament, and that a European Parliament task force be created to monitor the prices of medicines.
In their June 2016 Council Conclusions, the European Council also emphasised the importance of facilitating the availability of generic and biosimilar drugs to improve patient access. Medicines for Europe has issued a statement in support of the report, and has additionally called upon the European Commission to allow for the export of generic and biosimilar medicines to countries where no patent or supplementary protection certificate currently exists.
As the draft report was accepted, the next step is for the report to be presented in the plenary session of the European Parliament.
“After many debates, the Parliament is aligning with the Council to make competition from generic, biosimilar and value added medicines a high priority in policies to support access to medicines,” Adrian van den Hoven, Medicines for Europe director general, said in a press release. “The Commission should now take action to ensure that these proposals are translated into real measures so that all patients across Europe get the access they need.”
Catherine Saez contributed to this report.
The draft report proposed numerous measures to increase access to medicines, asking the parliament to study the impact that intellectual property protections actually have on promoting innovation and to increase publicly funded research to better address patient need. Direct measures to control the cost of drugs and increase competition were also requested, including regular monitoring of patent settlement agreements which may restrict entry of generics into the market, guaranteeing timely entry of generic and biosimilar drugs, and ending patent linkages.
The report calls upon the European Commission to strictly limit the effects of Supplementary Protection Certificates and data exclusivity or market exclusivity on competition. These certificates extend a patent to compensate for the time spent on clinical trials and testing, and can last for up to 5 years.
The report also calls on the EU Commission and member states to make use of the flexibilities contained in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and “to coordinate and clarify their use when necessary.”
Also proposed by the report is that the Commission examine and compare the prices of medicines in the EU and present an annual report to the Parliament, and that a European Parliament task force be created to monitor the prices of medicines.
In their June 2016 Council Conclusions, the European Council also emphasised the importance of facilitating the availability of generic and biosimilar drugs to improve patient access. Medicines for Europe has issued a statement in support of the report, and has additionally called upon the European Commission to allow for the export of generic and biosimilar medicines to countries where no patent or supplementary protection certificate currently exists.
As the draft report was accepted, the next step is for the report to be presented in the plenary session of the European Parliament.
“After many debates, the Parliament is aligning with the Council to make competition from generic, biosimilar and value added medicines a high priority in policies to support access to medicines,” Adrian van den Hoven, Medicines for Europe director general, said in a press release. “The Commission should now take action to ensure that these proposals are translated into real measures so that all patients across Europe get the access they need.”
Catherine Saez contributed to this report.
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