Safety vs speed: how the EU regulates drugs

Compared with its input into national issues in farming, the environment and banking, the EU’s influence on the Irish health system appears relatively slight.

Health is one of those areas where the primacy of member states holds sway and the European Commission plays a minor supporting role. With the exception of underused cross-border provisions that allow people to access health services in other member states and the health insurance card many of us take on our holidays, Europe’s visible input into health policy is decidedly low-key.

And yet it is there, under the radar. One area where the commission’s health and food safety directorate plays a central and sometimes controversial role in shaping the world of health is the regulation of the pharmaceutical industry.

The commission established a common system for authorising new drugs and, later, for adopting a single, Europe-wide procedure. New rules for standard labelling, clinical trials and falsified medicines were devised, and patients were given a formal role in the process, even if that took 35 years.

The EU’s regulatory role in pharma is 50 years old this year and the anniversary was marked recently at a conference in Brussels that brought together industry, regulators and patient groups at what is undoubtedly a time of great change for the sector.

Regulation has improved in the past 50 years, to provide patients with the drugs they want during a period of rapid technological change. Now, however, there are huge questions about the affordability of new medicines, fears of a dearth of innovation in some areas, and concerns about the ethics of and secrecy surrounding clinical trials.

Appalling birth defects

The need for the first regulations back in 1965 came on the back of the horrific experience with Thalidomide, a drug given to pregnant mothers that caused appalling birth defects in their children. The affair exposed the laxity of the system that applied at the time in Europe, where thousands of women were affected; by contrast, the more cautious approach taken across the Atlantic ensured there were fewer than 20 cases in the US.

“Fifty years ago, alarm bells rang for us all. It made clear that we must take action to safeguard public health. The painful lesson we have learned should never leave our sight,” EU health commissioner Vytenis Andriukaitis observes.

Today, regulators struggle to balance the requirements of safety against the desire of drug companies to get their products to market as quickly as possible and the demand among patients for early access to possibly lifesaving treatments.

There is a recognition that the US moves faster in regulating medicines and has performed better in ensuring patients have access to new therapies. And, even though safety considerations are paramount and there has been no repeat of anything on the scale of Thalidomide, there have been occasions when patients on clinical trials have suffered severe adverse events.

As one speaker at the conference told the EU commissioner, the Volkswagen fuel emissions scandal shows the shortcomings of European regulation, albeit in another area. Andriukaitis’s response was to agree that regulators on both sides of the Atlantic can learn from each other “but you can’t read too much into a single scandal”.

Acceptable levels of risk

One of the central questions under discussions at the conference was: “How much risk are we prepared to accept in regulating to allow patients early access to new drugs?”

Critics of the industry say regulators are too quick to fast-track new drugs or to accept results from smaller trials than were previously accepted.

Prof Tamara Hervey, an expert in European law at the University of Sheffield, believes risk regulation is a “social construct” rather than a rational scientific measure. “The regulation of pharma is about the extent to which the regulators can control the power of global capital,” she says. “The question is ‘What protection are the European institutions prepared to give their citizens against this power?’ ”

The industry, of course, doesn't see it this way. "The European Medicines Agency needs to stay abreast of the science and to be able to work even faster," says Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries and Associations.

“Other regulatory agencies are faster, suggesting that patients elsewhere have earlier access to new medicines. As the pipelines of my companies are full of truly innovative medicines, speed is of the essence.”

One pressing problem facing Europe is a collapse in the number of clinical trials being carried out; down from more than 5,000 to 3,800 in four years.

The reasons, according to commission official Stefano Soro, are varied: reduced public expenditure on research, competition from other countries, and the administrative burden imposed by new rules introduced in 2001.

The commission’s response is to make Europe more attractive for clinical trials by introducing a single application procedure and simplified reporting rules. Work is still ongoing on the new rules, which aren’t due until 2017.

But while the EU wants to see more research and development, some speakers at the conference claimed there was too much duplication already and the coming decade would see consolidation in the research sector.

Whatever happens, with the pharmaceutical sector worth about €150 billion a year to Europe, there’s clearly a lot at stake for both Europe and Ireland.