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The European Medicines Agency responds to concerns over conflict of interest and openness.
In the latest of a series of mea culpas from the European Medicines Agency, new rules have emerged on how it will be handling potential conflicts of interests of its scientific experts. The new rules, endorsed by the agency's management board in early October, aim at snuffing out some of the controversy that has become increasingly acute over the independence of advisors.
The agency has been pushed into applying a more proactive approach by repeated suggestions that its scientific opinions can be tainted by its dependence on experts who carry out work for drug firms.
It is promising to do more to identify potential conflicts, and to be more energetic in seeking alternative experts when the need arises—as is often the case with rare diseases, where the pool of experts is often small. It is going to screen all proposed members of its scientific committees prior to their formal nomination.
The possibilities of conflicts of interest arising are classified as direct or indirect—or as zero, because of "no interests." The classification assigned to each expert or member of the agency's scientific committees is based on a signed individual declaration of interests, which details any financial or other interests that could affect impartiality. According to the risk level assigned, involvement of the expert may be restricted, in view of the nature of the interest declared, the time passed since the interest occurred, and the activity the expert will be involved in.
The agency's line is that the new rules will balance out "the need to secure Europe's best scientific experts for the evaluation and supervision of medicines while ensuring that these experts have no financial or other interests in the pharmaceutical industry that could affect their impartiality."
Noel Wathion, Head of Patient Health Protection at the agency, said as the new rules were announced: "We take this work seriously and review our processes continuously to be sure that we take all steps necessary to protect our scientific opinion-making against the influence of any improper interests."
And so that justice is not just done, but seen to be done, the agency is boosting public access to information on experts' links to industry. Declarations of interests will appear on the agency website not only for all members of the scientific committees, but also for all the other experts included in the agency's database—who run into thousands.
Putting the policy into place will take some time, because of the practical implications, so the new system is not expected to be up and running much before the middle of 2011. But it is yet another straw (a rather substantial one, at that) in the wind that is sweeping across Europe to shake up any cozy relations that operate against the public interest.
The suspicions—which are not, in any case known to this columnist, proven—that have prompted the agency to this new move were in prominent view over the authorization of H1N1 vaccines last year, during the flu epidemic. Only weeks ago, French Green member of the European Parliament Michèle Rivasi staged a hearing in Brussels that bore something of the marks of a witch-hunt. She has repeatedly alleged that there might have been something inappropriate in the alacrity with which authorizations were rapidly given to expensive medicines that subsequently proved to be unnecessary—and even possibly to have unexpected side effects.
She and fellow members of the parliament's health committee looked back at what happened, and forward to what lessons they thought could be drawn for the future. Rivasi said, "We need clarifications on transparency and expertise of the European institutions." The questions posed to the authorities at the hearing included how far the pandemic was properly managed, whether the risks and benefits were sufficiently taken into consideration when authorizing the vaccines, and whether there were any deficiencies with regard to the decision-making.
EU officials and diplomats responded robustly. There had been good cooperation, coordination, and synergies, said Andrzej Rys from the European Commission. Anita Janelm of Sweden, which held the rotating chair of the EU presidency at the time of the outbreak, pointed out that during a crisis, decisions often have to be taken even when not all information is available. "In such situations it is better to do more than do less and be criticized for actions taken, instead of being criticized for not acting when actions were really needed," she said. Georgette Lalis of the European Commission said the decision was made to give market authorization for vaccines even though the pre-clinical data was not always available because the World Health Organization raised the alert level. But, she added, "we pushed to the extreme what our scientists could give us." Thomas Lönngren, Executive Director of the EMA, said the risk/safety balance was good, since 45 million people were vaccinated with no serious side effects being detected.
Members of the parliament also wanted to know what changes should be made to EU response planning, particularly to ensure independence, excellence, and transparency of decision-making. Lönngren acknowledged that healthcare professionals and patient representatives should be more closely involved, and, he went on, that a more flexible approach to pandemic flu vaccine authorization is needed. Paola Testory Coggi, director general for health in the European Commission, promised more coordinated measures to face cross-border pandemics, with a proposal for new regulation next year.
The growing demand for reassurance that regulation is operating in the public interest have also spilled over into concessions from the authorities on greater access to documents. The European Medicines Agency also set out in October a new policy on how it will deal with written requests for access to documents related to medicines that the agency has originated, received, or holds.
Readers of this column may recall that earlier this year the agency acceded to urgings from the European Ombudsman to release documents relating to Roaccutane, in what is something of a test case for the agency.
The new agency policy explicitly takes into account the recommendations from the ombudsman, as well as input from a broad public consultation it organized. It says it "will ensure the widest possible access to EMA documents"—although it continues to insist that some documents, or part of them, may have to be edited prior to disclosure, to protect commercially confidential information and personal data.
It is not only the authorities that are under closer scrutiny over their independence from big pharma. Patient associations are repeatedly and increasingly under attack for acting as front-men for drug firms as much as defenders of the sick.
A number of recent exposés of supposed skullduggery have highlighted the failure of some well-known patient associations to observe the letter of the law in disclosing the interests of their officers. In consequence, the European Medicines Agency is contemplating another tightening up of its rules, so as to impose new criteria on admitting organizations of this type to its advisory panels.
There is, indeed, a palpable sense of paranoia running through many parts of the European health machinery at present. The ruling presumption seems sometimes to be that scientists cannot make decisions independently, that authorities are too easily influenced by the drug industry, and that patient associations are untrustworthy advocates because they are often funded in part by drug firms.
These sentiments are fed specifically in the health sector by energetic health activists who constantly question the current systems, and more generally by a growing range of what might be termed professional skeptics—not just the media (although they too have a role in this), but particularly by groups who monitor the work of lobbyists in the hothouse atmosphere of Brussels. There can be little doubt about the merits of skeptical questioning in principle: examples of abuses of position and trafficking of influence emerge almost every day across Europe, and it is a good thing that they are exposed and, in many cases, remedied. But in the health sector, the same risk/benefit equation applies to this sort of assessment as it does to any clinical trial protocol or indeed any medicine authorization.
The best scientists may, in fact, occasionally—or even often—work on the trial of a new medicine, and be paid for doing so by a company developing the medicine. At the same time, regulatory authorities need the best scientists as experts to help reach the best decisions on new medicines. Rigorously excluding them from crossing that frontier will impoverish either medicines development or regulatory activity—and possibly both.
Similarly, although many patient associations take money from pharmaceutical companies, they do not necessarily represent companies' interests rather than the interests of their members. To put an end to any link between the two would certainly bring the activities of many patient associations to an abrupt end. It would also probably have a negative impact on development of medicines—particularly for some of the niche diseases where patient associations play an important role.
So some moderation is necessary to prevent excessive enthusiasm for purity—or rather enthusiasm for a purity that could be obtained only at a high cost. What the European Medicines Agency is doing on conflicts of interest and access to documents is a sensible response to current pressures. It might have been even better had it been a spontaneous measure. It is right that the European Parliament should question the authorities on controversial decisions—and suspicions and accusations are best dealt with by such open exchanges, so that they do not develop into widely-held but unsupported urban myths. Greater transparency over patient association funding is a legitimate demand—not to close them down, but to allow them to continue valuable work without being subject to constant allegations of playing for the other side. But it would be foolish to assume that scientists or authorities are so naive that they would be subverted by everything that came out of a patient association.
Ultimately, balance is the only answer—and balance often has to change in the light of changing conditions. So as transparency rides again, it is, yet again, a new ride in new circumstances. Don't fall off.
Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.