Healthy Skepticism Library item: 17080

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Publication type: news

Taylor L
Incoming EU health chief pledges action on patient drug info
Pharma Times 2010 Jan 19
http://www.pharmatimes.com/WorldNews/article.aspx?id=17239

Full text:

Europe’s new Health Commissioner-designate has pledged new initiatives to break the deadlock on Commission proposals to liberalise controls on the provision of prescription drug information to patients.

The current draft directive needs to be reassessed to “bring more patient’s perspective in the proposal,” said John Dalli, who is Commissioner-designate for Health and Consumer Policy (SANCO) in President Jose Manuel Barroso’s new Commission, and currently serves as Malta’s Minister for Social Policy. He was speaking in front of a three-hour hearing, held late last week by the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) to consider his nomination.

His comment that there might also be a need for a “harder demarcation between industry and advertising” – the issue which continues to stall the proposal within the Council of Ministers – was well-received by the MEPs.
“Patients have the right to have access to proper information on prescribed medicines – we have to re-assess the proposal and put a better one on the table,” said Mr Dalli, a member of Malta’s National Party which is affiliated to the European People’s Party (EPP) in the European Parliament.

Mr Dalli would also be taking on responsibility for the European Medicines Agency, and in his written answers to the ENVI panel he says he is looking forward to the upcoming evaluation report on the Agency’s functions “and, in this context, to evaluating whether there is scope for measures whereby we can optimize the bringing of new medicines to the market as quickly as possible, and with the minimum of expense.”

MEPs were less enthusiastic about his call for the pharmaceutical legislation package to be “unbundled” to allow its non-controversial aspects – initiatives to tackle counterfeit medicines and improve pharmacovigilence – to proceed speedily, and they warned him that this could lead to unwarranted dilution of some of the package’s most substantial proposals.

Mr Dalli pledged that, if Parliament confirms his appointment, he will act as “the guardian of consumers’ interests in the college of commissioners,” and that this would be his position in the event of a conflict arising between consumers and the pharmaceutical sector. However, he also stressed the importance for Europe of a strong pharmaceutical industry.

In his written answers, Mr Dalli emphasises the need to make affordable, safe and efficacious medicines available to patients across the EU, and adds: “the integration of the pharmaceutical area into public health is one that requires careful management and I look forward the to challenge. We must strive to reinvigorate this sector through innovation and enhancing its economic competitiveness. This is not in contradiction to the paramount principle of patient safety.”

Mr Dalli states that, under his watch, the fight against counterfeiting would be intensified “not only because this is an affront to consumers but also because this attacks Europe’s economic wellbeing, especially as it undermines innovation.”

Emphasising his “intense commitment” to tackling counterfeit medicines, he calls on Parliament and all stakeholders to work to develop initiatives. He adds: “I am ready to work with my fellow Commissioners responsible for Justice, Fundamental Rights and Citizenship and Taxation in order to develop an effective response in the interests of consumers.”

MEPs at the hearing welcomed Mr Dalli’s pledge to work closely with Parliament. In his written answers, he notes that the closure of a number of “ongoing dossiers” including the pharmaceutical package will depend on the decision-making progress, and states: “I am aware of the sensitivities surrounding these issues and want to explore with you and with all stakeholders the right and quick solutions.”

And at the hearing, he told the legislators: “I’d rather spend time earlier in the legislative process talking about policies with you than spend time fighting on policies with you at a later stage.”

- In the new European Commission, the move of responsibility for the pharmaceutical industry from the Directorate General (DG) for Industry and Enterprise to DG Health and Consumer Safety (SANCO) has been welcomed by consumer and patient groups. One of the reasons holding back progress on the information directive has been concern that it was drafted by DG Enterprise and Industry – whose responsibilities include regulatory and industrial policy for the pharmaceutical industry – rather than DG Sanco, which is concerned with consumers and public health.

While countries including Denmark, Sweden and the UK support the Commission’s proposals, a number of others – including France, Germany and Spain – oppose any move to liberalise controls on the provision of prescription drug information, for reasons including the fact that the draft does not distinguish sufficiently between “information” and “advertising.” They also believe that the industry should have no role in the provision of information to patients and that the proposals would drive up health costs by increasing demand and because of the need to set up monitoring mechanisms.

Following its hearings, Parliament is expected to hold a vote of consent on the new Commissioners on January 26, after which they will be formally appointed. The new Commission will then start work in February and its term of office will run until October 31, 2014.