Pharm Exec’s EU correspondent, Reflector, looks at some of the European regulatory developments earmarked for 2014 and anticipates their effect on the industry.
Pharm Exec’s EU correspondent, Reflector, looks at some of the European regulatory developments earmarked for 2014 and anticipates their effect on the industry.
Personnel
Some of the big influences on the pharma industry in Europe next year - and for several years to come - will be the big changes upcoming in key personnel in the European Union institutions.
The European Parliament will hold its five-yearly elections in May, and many of the familiar faces that have supported - or attacked - the industry will disappear. The com
position of the next parliament will influence EU policy right across the board, from health to industrial affairs, and from intellectual property to competition. And the likelihood is that wide public disaffection with the EU will result in a parliament with a much more eurosceptic, radical, and unpredictable approach to policy-making - all the more disconcerting since this will be the first new parliamentary term since the parliament gained increased powers in EU decisions with the Lisbon treaty.
The European Commission’s term also expires late in 2014, which means all the current 28 commissioners are out - and few, if any, of them will be back. Certainly there will be a new commission president - Barroso has said he is not bidding to return - and Joaquín Almunia, who has pursued the industry relentlessly on the patent pay-for-delay cases, will not retain the competition portfolio (although he may press all the harder for action on the outstanding cases as he clears his desk).
The legislative calendar
The EU will continue to grind through its legislative calendar in the field of health, notably on the below:
Strategic pressuresDriven more by the political context than by specific policy-making, strategic pressures will exert increasing influence on the industry.
Challenges and opportunities
Specific changes in the administrative arrangements confronting the industry will also present challenges as well as opportunities.
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