The European Regulatory Outlook for 2014

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:

• New rules on clinical trials, in a belated bid to keep Europe an attractive location for clinical research after the debacle of the rules introduced in 2001, which made multi-center trials harder rather than easier to perform across Europe.

• The update to EU rules on medical devices (also covering in-vitro devices) proposed in 2012. The outcome, particularly in relation to diagnostics, will have more significance for personalized medicine than might at first appear.

• A proposal to charge fees to companies to pay for the new work on pharmacovigilance that the European Medicines Agency is increasingly undertaking.

• New rules adopted in November on countering serious cross border threats to health provided for joint procurement of medicines and vaccines.

• Particularly on clinical trials and on medical devices, the race is on to secure full agreement of member states and European Parliament before the end of the parliamentary term in April 2014.

Strategic pressuresDriven more by the political context than by specific policy-making, strategic pressures will exert increasing influence on the industry.

• Austerity economics and demographics will focus thinking ever more closely on the new slogan of sustainable health systems (which can often be translated as cuts in current health spending).

• Greater attention to prevention will offer opportunities for vaccines, for diagnostics, and for screening.  Greater focus on value-for-money - and more sophisticated evaluation mechanisms that recognise the concept - can offer opportunities for innovative medicines.

• Calls for more equitable access to healthcare, which form an important element in the ‘sustainable health systems’ concept, could offer some opportunities for redressing the imbalances in availability of medicines across Europe – that is, if the momentum results in increased reimbursement in countries currently offering limited access (predominantly in eastern Europe).of the rules on rights for cross-border patients, which has just started (very slowly in most countries) could also bring opportunities, as, in addition to its specific provisions for cross-border prescribing, it could expose wide discrepancies in many aspects of healthcare provision.

• Widening demands for accountability, transparency and good governance in all aspects of business and politics will tighten monitoring on the drug industry and on regulators. Calls for stronger provisions to prevent conflict-of-interest will multiply in the face of persistent public distrust.

• Trade issues will preoccupy many managers with international responsibilities. The EU–US trade talks may deliver some of the hoped-for alignment of regulatory requirements during the course of the year.

Challenges and opportunities
Specific changes in the administrative arrangements confronting the industry will also present challenges as well as opportunities.

• There should be new opportunities for research funding from the EU’s $100bn programme to support innovation which comes into effect at the start of 2014 and runs through to 2020. As much as a tenth of this funding could be accessible for life-sciences research. Much of the money will be channelled through IMI2, the successor public-private partnership to the Innovative Medicines Initiative, which also kicks off in 2014. Favoured areas will include chronic diseases such as diabetes and dementia, and attempts to fill the antibiotics gap.

• Within the European Medicines Agency, efforts will continue to derive greater efficiency from the almost constant reorganization underway since Guido Rasi took over two years ago. But the strains as the workload grows are evident to everyone in contact with the agency, and tighter resources - the agency faces a budget cut in 2014 - are likely to make implementation even harder.

• In broader terms, the pressure will continue to grow for closer links between marketing authorization procedures and health technology assessment.

• As the EU’s legislation on combating falsified medicines comes more fully into force, the industry will have to put in place measures for identifying and verifying individual packs - and 2014 is the year that major decisions will be required on methods and on investment.