EU shake up for pharma
pharmafile | December 2, 2009 | News story | Research and Development, Sales and Marketing | Commission, Europe
Responsibility for pharma and biotech policy has been taken away from the European Commission’s Enterprise and Industry directorate and handed to the Health and Consumer directorate.
Making it part of the Health and Consumer (SANCO) portfolio enshrines the idea that health, not business, is the main driver for decisions about pharma issues at EU level.
As part of the changes, SANCO will also oversee the European Medicines Agency (EMEA) under commissoner-designate John Dalli, currently the Maltese minister for social policy.
European industry association EFPIA said it hopes Dalli “will help maintain the existing policy balance” between the pharma industry’s work in meeting patient needs and its “significant contribution to Europe’s economic well-being” – which includes a positive trade balance, employment and “substantial investment in European-based research”.
The European Public Health Alliance (EPHA), which represents patient and professional groups as well as NGOs, lobbied for the change and welcomed the move.
Monika Kosinska, EPHA secretary general, said it “puts public interests and the health of Europeans at the centre of vital decisions affecting our health”.
The EPHA, along with the European Consumers Organisation and Association Internationale de la Mutualite, had made the case for change on the grounds that access to medicines is a human right.
“Pharmaceutical policy is an integral part of public health policy making,” their statement said. “Medicines form a major part of treatment measures and are therefore of key importance in safeguarding health.”
“Pharmaceutical policy making should put health and human rights at its core,” they added.
Yet even the EPHA described the decision by EC president Jose Manuel Barroso to restructure responsibilities as “bold”.
In addition to taking control of the pharma products and cosmetics units from ENTR, SANCO also gets the biotechnology, pesticides and health unit from DG Environment.
SANCO has lost responsibility for consumer contract and marketing law to DG Justice, Liberty and Security.
The announcement was made as part of a raft of changes to the Directorates in the wake of the ratification of the Lisbon Treaty.
Pharma companies will be interested to how Barroso’s commitment to a ¿smart regulation agenda¿, as he described it in a letter to the commissoners-designate, pans out.
His new Commission must be approved by the European Parliament before it takes office, perhaps as early as January next year, and then its term of office would run until 31 October 2014.
Barroso’s other touchstones include respecting subsidiarity and proportionality, sound financial management in the EU, and respect for the Code of Conduct of the Members of the European Commission.
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