European drug regulation: Past, present and future

Print 21 April 2015
Cormac Sheridan / BioWorld

PARIS – Better patient safety has been the single greatest benefit of Europe’s system of pharmaceuticals regulation and legislation over the past 50 years, according to an audience vote at a Regulatory Town Hall meeting, which kicked off proceedings at the Drug Information Association’s (DIA) 27th annual European meeting at Le Palais des Congrès in Paris, Monday.

Thankfully for the expert panel assembled to provide a commentary on the key issues affecting drug regulation – which included the heads of three national regulators as well as the de facto head of the EMA, Guido Rasi – only 2 percent of the audience thought that no significant benefits had accrued. Moreover, those who picked that option probably did so out of a sense of provocation or mischief.

The audience also considered the development of a more centralized system of drug authorization in Europe, but one staffed by multinational teams of rapporteurs, as being the favored option for the future development of drug regulation in Europe and beyond. It received 58 percent of the vote, while the creation of a worldwide medicines agency was the second most popular, with 23 percent in favor – enough to make session chair Fernand Sauer, the founder and founding director of the EMA and a linchpin in the development of Europe’s pharmaceuticals legislation to quip: “Although I’m retired, I could volunteer again.”

The session comprised a look back over the past 50 years of the painstaking construction of a system of regulation in Europe, from basic registration procedures adopted in the UK and Germany in the wake of the thalidomide scandal in the early 1960s to the complex system of EU member states, as well as a look forward to, or at least a consideration of, the issues that lie ahead.

Europe’s development of legislation for orphan drugs and for pediatric patients are two successful examples that can be built upon, Andrzej Reys, Sauer’s successor as the EC’s director of health systems and products, told delegates. Older patient groups and pregnant women are not well served by the present system, he said. More innovation is needed – as well as incentives to support that innovation. “Have we already a toolbox of business models available to stimulate innovation, so private companies will invest in these areas?” he asked. “Or do we just look at each other and wait for someone else to do it? I’m not pessimistic,” he said.

SURVEY SAYS . . .

When the audience was asked to identify the main drivers for accelerating therapeutic innovation and facilitating patient access to new interventions, the responses here were split more evenly across several options, reflecting the uncertainty attaching to the benefit of technologies and regulatory processes are often talked about but which are still in their formative phases. Thirty percent voted for equal access for all patients to treatments, determined by the EMA and by health technology assessments. Adaptive regulatory pathways garnered 28 percent of the vote, while more international harmonization came third with 26 percent. Big data fared poorly in the vote, trailing in fourth, with 9 percent of the vote, just ahead of what was regarded as the least significant option, increased transparency, which pulled 7 percent.

The opening plenary that followed might have influenced the vote had it been held a second time. Delegates heard a keynote address from Andrew Morris, a diabetologist based at the University of Edinburgh and chief scientist to the Scottish Government, who outlined how Scotland’s health system is beginning to reap the benefits of a data-centric, systemwide approach that is starting to cuts costs while delivering on better outcomes. Since 2007, Scotland has been capturing the key disease measures of 95 percent of its 268,000 diabetics. During this time limb amputations have been cut by 40 percent, as has diabetic retinopathy.

“It’s my ambition that we’ll have a year when no one will go blind from diabetes in Scotland,” Morris said. Moreover, the gains in retinopathy have been made even while reducing – with the help of solid clinical evidence that aids patient stratification – the amount of screening.

The achievements extend well beyond diabetes. Some 300,000 people in Scotland have now given their consent for participating in genomics studies. Industry now has a single sign-off for clinical trials. Median time for trial approvals is now 19 days, which has resulted in the country becoming a globally competitive center for studies. And 1 million people have given their consent to be contacted and screened for potential participation in future studies. Trust in the system is the single most important ingredient, Morris said.

FDA, EMA DIVERGENCE: GOOD ENOUGH?

During the same session, Olivier Charmeil, CEO of Sanofi Pasteur, the vaccines arm of Paris-based Sanofi SA, argued that greater convergence, particularly between the FDA and the EMA, would help industry make investment decisions with greater confidence and eliminate costly duplication. “I’m not a dreamer – I don’t think regulatory convergence will happen in my lifetime,” he told delegates. But more of it wouldn’t hurt. Hugo Hurts, executive director of the Medicines Evaluation Board of the Netherlands replied that it wasn’t necessarily desirable, however. “A certain level of competition between regulators makes the system stronger,” he said. Guido Rasi, who also participated in the plenary session’s panel discussion, offered a more subtle response to the charge that the FDA and the EMA often diverge on regulatory decision-making. “It’s maybe not good, but it’s good enough,” he said.

Back at the Town Hall session, the final vote considered the main focus of pharmaceutical oversight during the next decade. Personalized medicine was deemed most significant, with 39 percent of the votes, followed by 32 percent for improving patient-relevant endpoints in clinical trials. Simplifying variation procedures, improving pharmacovigilance and combating counterfeit medicines were deemed less important. These are opening positions only, however. The conversations and sessions that will follow this week could well alter those views. The meeting continues Tuesday.

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