Peter O'Donnell
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New rules for pharmacovigilance are on the way in Europe. European Union health ministers took their first look at the proposals*
in June, and changes can be expected to be decided before the end of this year. The initiative comes from European industry
commissioner Günter Verheugen, who made clear last December when he announced a "pharma package" of proposed new rules that
he was determined to tighten up EU monitoring of adverse effects.
Although ministers took no decisions when they met as the EU health council on June 9, they did have an opportunity to review
the progress made by the expert working party of national officials that is examining the draft. An extensive report lists
where consensus is emerging—and where it is not.
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The objective as defined by the Commission is to "strengthen and rationalize" the EU pharmacovigilance system to ensure full
and equal coverage for "all relevant products" across the EU, "with a view to preventing unnecessary patient exposure to risks."
The proposals envisage clearer roles for everyone involved, greater transparency on medicines safety and on the way companies'
pharmacovigilance systems function, better quality data-collection, and closer involvement of patients.
Among the proposals The proposals suggest tougher obligations on companies to provide information on their products. "The marketing authorization
holder shall forthwith supply to the national competent authority any new information which might entail the amendment of
the particulars or documents" covered by the authorization, and "In particular, he shall forthwith inform the national competent
authority of any prohibition or restriction imposed by the competent authorities of any country in which the medicinal product
for human use is marketed and of any other new information which might influence the evaluation of the benefits and risks
of the medicinal product for human use concerned."
This information is to include both positive and negative results of trials or other studies in all indications and populations,
whether or not included in the marketing authorization, as well as data on the use of the medicinal product not in accordance
with the summary of the product characteristics.
In addition, the marketing authorization holder "shall ensure that the product information is kept up to date with the current
scientific knowledge," and "in order that the risk-benefit balance may be continuously assessed, the national competent authority
may at any time ask the holder of the marketing authorization to forward data demonstrating that the risk-benefit balance
remains favourable."
The EU's Working Party on Pharmaceuticals and Medical Devices—the technical experts from the 27 member states—has so far examined
the proposals six times, and all countries are still holding back from a general endorsement of the proposals. This does not
mean they fundamentally oppose it.
As is clear from the report—drawn up by the Czech Republic, which has been in the EU's rotating presidency seat for the first
six months of this year—there is general agreement among national officials that "these important proposals must be pursued
with high priority." But officials from some countries are not convinced that the proposals meet the designated objectives,
and many national delegations to the working party have reservations on individual provisions.
For instance, while there is broad agreement that a new scientific committee responsible for pharmacovigilance should be set
up in the EMEA, there are divergent views over who should sit on it. The proposals foresee a committee with 10 members appointed
by the EMEA Management Board and five members appointed by the Commission, but nearly all the member states insist on every
country having a seat. A compromise is under discussion under which every member state would have the right, but not the obligation,
to actively participate in the work of the committee.
