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EU Approach to Safety: Vox Populi or Vox Dei?

In late February, the European Union announced it was launching a review of its rules on pharma-covigilance. It is not surprising that the EU should decide a review of pharmacovigilance is necessary. This is a constantly evolving discipline requiring constant alertness to how well it is meeting the objectives set for it.

What is surprising is the way that the EU chose to justify it in the formal announcement. In a statement entitled "Strengthening Medicines Safety Monitoring," it said: "A public consultation shows that the current EU system of medicines safety monitoring (pharmacovigilance) needs rationalization and strengthening."

This suggested a strange approach to medicines regulation, in which public consultation is to be the arbiter of whether pharmacovigilance rules are adequate. Should public consultations, by the same logic, also come to be the mechanisms for deciding on the requirements for clinical trials, or the authorization conditions for medicines—or, indeed, for the delivery of airworthiness certificates for jumbo jets or the approval of nuclear power plants?

There is nothing antidemocratic in this reflection. There are plenty of vivid illustrations to hand that democracy, for all its faults, provides a better system of government than any other system so far developed. In this respect, vox populi—the voice of the people—may be reasonably considered vox dei—the voice of God. But consulting the people on who they want to run a country or a town hall is not the same as consulting the people on intensely technical or scientific matters. Citizens cannot be reasonably expected to make fine distinctions between different reporting procedures for adverse drug events—or to accurately assess the reliability of a fail-safe system for a water cooled reactor. Responsible technical or scientific regulation should respond primarily to technical and scientific considerations. It would be an abdication of responsibility for authorities to leave crucial decisions uniquely to public opinion. The results of a public consultation might be one of many reasons for a regulatory review—but when public consultation is advanced as the determinant trigger of regulatory action, it might suggest that the authorities are losing the plot.

The proposed measures

So much for the process. What of the substance? The EU says that the current EU legal framework is "complex and duplicative" and that "there is a need to clarify roles and responsibilities." Divergent implementation by member states has led to complex and diverse reporting requirements for the industry, according to the EU analysis, and "decision-making at EU level is overly complicated."

The EU aims to strengthen the rules on transparency over pharma-covigilance data, assessment, and decision making and to involve representatives of patients and health care professions more closely. It also envisages clear standards—to be known as "Good Vigilance Practices" (GVP)—for industry and regulators. It wants to simplify both expedited and periodic reporting of suspected adverse drug reactions, matching the reporting requirements with the level of knowledge about the safety of a specific product. A clear legal requirement will be imposed to conduct postauthor-ization safety studies, and decisions on products will be equally and fully implemented across all 27 EU markets.

EU analysis

The new approach will include funding studies into the safety of medicines and into the methodologies used to conduct pharmacovigilance, working with the member states to prevent national administrative practices complicating reporting rules for industry, and boosting coordination by the EU's London-based medicines agency.

The EU analysis at the base of the initiative is that there is abundant evidence of the public health burden that adverse drug reactions cause: Adverse reactions to medicines are "a common cause of death," and "weaknesses in the system continue." Slow and cumbersome action in response to drug safety alerts "puts patient safety at risk."

European Commission Vice-President Günter Verheugen, who is responsible for industry affairs, said: "We will improve and strengthen the monitoring of the safety of medicines so that safety issues are rapidly detected and effectively dealt with on the basis of more robust data." His thinking is scheduled to emerge as a formal legal proposal in 2008. "Rationalization of the EU medicines safety system will free up resources, which can then be directed to better protecting the health of EU citizens," he said.

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