Europe loses as trialogue negotiations on proposed Advanced Therapies Regulation fail


EuropaBio is deeply disappointed by the breakdown in the informal talks between the Parliament, Council and Commission which were looking to reach an early agreement on advanced therapies regulation, but instead ended without any concrete outcome after two months of negotiations and a rescheduling of the vote in plenary from March to the end of Apri.

According to EuropaBio, patients, academia and industry are all waiting for the proposed advanced therapies legislation to be in place, in order to provide a centralized approval process for innovative therapies that will deliver harmonised safety standards and increase access to medicines that have the potential to save lives and improve quality of life.

The informal trialogue meeting talks broke down when the Rapporteur insisted on including two amendments in the agreement package that would exclude certain advanced therapy medicinal products from the scope of the regulation. To include these amendments would cause certain products and technologies to remain unregulated, posing potential health hazards to European patients and disadvantaging Europe's emerging Advanced Therapies sector.

"We cannot imagine that it is the intention of the Regulator to have unregulated products," said Johan Vanhemelrijck, EuropaBio Secretary General. "We understand that the trialogue negotiations aimed at reaching an early agreement were started on the basis that these amendments would not be included in the compromise package, due to the known differences between the Rapporteur, the Council and the Commission but nevertheless could be put to the plenary vote of the European Parliament." The insistence to include them in the compromise package has now put the whole Regulation in jeopardy. Therefore, EuropaBio calls upon the Rapporteur to continue with the approach that had been originally agreed.

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