How will EU regulation keep pace with future therapies?

Published: 20-Jan-2016

At the ‘50 years of EU Pharma Legislation’ conference in Brussels last September, the need for changes to regulatory structures and practices was highlighted. Manufacturing Chemist explains why and where these changes are most needed

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In opening the conference, Dr Andrzej Rys, Director for Health Systems and Products, at the European Commission’s directorate general (DG) for health and food safety, argued that EU rules respond to real problems in the industry. He noted that this half century anniversary coincided with the European Medicines Agency’s (EMA) 20th birthday and said that this was ‘a perfect moment to reflect on what has been achieved’.

Delegates were keen to recall how the thalidomide tragedy of the early 1960s had inspired EU legislation, institutions and mechanisms, which established centralised authorisation procedures for the assessment of new pharmaceutical medicines. The EU health and food safety Commissioner Dr Vytenis Andriukaitis told attendees: ‘We cannot think of the future, without thinking of the past.’ And addressing the conference, thalidomide survivor Kevin Donnellon stated that while he did not see his life as a tragedy – he is living a full life in spite of his condition – he recognised the trauma inflicted on his parents, who had to manage and fight for his right to be treated equally.

Reminding authorities of their negligence in letting the thalidomide drug onto the market, Donnellon noted that while UK thalidomide survivors had received some compensation, although not enough in his mind, in some continental European countries survivors had received no compensation and so he would continue to campaign against this injustice.

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