Europe's Convergence Chasm on Drug Regulation

Fifty years after the first European Union (EU) drug regulation was adopted, it may seem odd to speak of Europe still edging towards European regulation in this field. After all, the EU will hold the equivalent of a ceremonial high mass late this month to commemorate that founding piece of legislation, lovingly referred to by devotees of the arcane as Directive 65/65/EEC. And since then the EU has seen a torrent of legislative initiatives on everything from drug pricing procedures to pharmacovigilance, and from orphan drugs to patent term restoration.

But despite all that investment of time and effort and expenditure, it is still the case that Europe is only in the "edging towards" phase of creating a genuinely European regulatory system. The current labors to put in place a functioning pharmacovigilance system, the new rules on clinical trials, or a health technology assessment process that can function across the 28 member countries are all eloquent testimony to the "work in progress" status of European drug regulation.

Nor is it just a question of limited resources or slow evolution and adaptation in the smaller member states, or the newer ones, or the poorer ones. Take, for instance, the case of France- a major pharmaceuticals-producing nation, a key protagonist among the original six countries that created the EU back in 1957, and ostensibly one of the principal influences on the way that drug rules have evolved in Europe. In the heat of this year's midsummer, the French health ministry published a three-year strategy for its drug regulatory agency that openly acknowledged how far France was out of step with the European mainstream in terms of drug rules, and set out plans to remedy the situation.

France playing catchup

The French National Agency for the Safety of Medicines and Health Products (ANSM), the country's newly-revamped regulator, must "define a global strategy for positioning on European issues, and set new targets for investment in the technical and scientific activities of the EU, in particular those of the European Medicines Agency (EMA)," says the plan bluntly. Impossible to imagine a clearer admission that until now, France, for all its huge merits and power, has not tuned in to what was going on in regulatory terms beyond its borders, and-above all-in the work of the EMA.

It is a recognition that springs not so much from wounded Gallic pride (although it is hard to believe that has not been at least a contributory factor), but from Gallic self-interest. As the plan goes on to remark: "The European commitment of ANSM is essential to face the challenge of globalization of the health product market"-in other words, French products are being disadvantaged-"and to ensure French influence in  European decisions that impact on the French market and French operators"-in other words, France is failing to punch French weight.

To some extent, therefore, the plan demonstrates a belief that somewhere, somehow, some European regulatory convergence is taking place, alongside the firm conviction that whatever is being plotted is not taking sufficient account of French interests. If the same view had issued from a small EU country like Luxembourg, or a poor EU country like Romania, or a new EU country like Croatia, it would be less remarkable. When it issues from the country of Schuman, De Gaulle, Mitterand, Giscard d'Estaing, Delors and other architects of what is now the EU, it is a powerful demonstration both that Europe is indeed still only edging towards drug regulation, and that one of the most significant countries in Europe is out of step with that faltering progress.

A self-inflicted wound?

France is, it has to be admitted, something of a special case in the European pharma context. The reason it has a newly revamped drug agency is that the predecessor agency became irremediably tarnished by a series of unhappy events-most notably the questions posed over the relations between its experts and the industry they were supposed to be regulating. The echoes of the Mediator case, the alleged connivance or incompetence that allowed a Servier drug to continue inflicting widespread damage on French (and foreign) patients for years, are still loud in the corridors of French regulators-and the French judiciary.

It also has a colorful place in the history of pharmaceutical regulation in Europe. For long the home of myriad national companies that were-so international competitors frequently complained-the beneficiaries of an administration geared to discriminatory tolerance towards its domestic manufacturers, its national drug industry has been buffeted and ultimately decimated by successive waves of tough competition (and acquisition) at European and global levels. The generous prescribing culture of the country has itself come under an unfavorable spotlight in recent years, too-often posing additional problems for companies with product portfolios that owed part of their durability to loyalty as well as to efficacy. 

Priority to pharmacovigilance

So what will France aim to do to gain-or regain-the position of influence that it feels it deserves? "The assessment and prioritization of this investment will continue," says the plan, but it then goes on to highlight some concrete areas of regulation where France definitely wants to be-and to be seen as-a key player.

One of the priorities is in the emerging EU legislation on pharmacovigilance, which, says the plan,  "completely reshaped the landscape of drug safety monitoring." Little surprise in this choice of priorities, given France's anguished background with Mediator. What the plan clearly identifies is the ambition for France to play a more prominent role in the workings of the EMA's newly-constituted risk assessment committee for pharmacovigilance, which meets every month. It expresses a commitment to "strengthen ANSM's internal coordination so that France retains an important and effective position in the work of and decisions taken within the European bodies involved in safety."

The plan even sets a performance indicator to measure how far ANSM is successful in  meeting this ambition. It is based on how far the French view is taken into account ("partially or completely") in EMA work on major issues on drug safety-including in arbitration on conflicting opinions, or periodic safety update reports, and the appointment of rapporteurs on contentious cases.

Another priority is to play a more prominent part in the EMA's core activity-the authorization of new medicines. "It is essential," says the plan, "that ANSM is committed to the assessment of marketing authorization applications in the EU's centralized procedure" and "to participating in the evaluation of applications for the launch of innovative medicines." So ANSM will "define and implement a strategy to position itself" when the responsibilities are allocated among member states for leading the European discussions on sensitive issues, "with the objective of strengthening the French influence on the authorization of medicines deemed to be strategic," and of "strengthening the role of France in Europe." And, again, it has established an indicator: it will measure its success in relation to "the number of centralized procedures attributed to France as rapporteur or co-rapporteur."

Still far to go

France is not alone in its ambitions, or in its commitment to review and strengthen its performance in drug regulation at the European level. Indeed there is hardly a country in the EU that is not conscious of the competition among national regulatory authorities to have a decisive say in the way that regulation is conducted in Europe. What makes France such a striking example of the trend is its sheer size and seniority among EU countries. But that merely reflects just how far the EU still is from regulatory convergence, and how far, even after 50 years, it still has to go.

Reflector is Pharmaceutical Executive's correspondent in Brussels