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European Commission proposes new patient information changes

Latest twist to medicine information saga further tightens up how pharma companies can use the internet

The European Commission has adopted new proposals on how pharma companies can supply the public with information on prescription medicines.

The changes would have a number of important implications for pharmaceutical digital marketing and further tighten up how companies can use the internet to provide information to the public.

If implemented, the internet would assume a primary role in providing patient information, the ban on using television, radio or printed materials would continue, and a new block on health-related publications would be introduced.

But the proposals do introduce the possibility that companies could make information available through printed materials, if a member of the public specifically requested it.

The Commission proposed new amendments to Directive 2001/83/EC and Regulation (EC) No 726/2004, both of which cover information to the general public on medicinal products subject to medical prescription.

It's the latest twist in Europe's medicine information saga, debate of which has already dragged on for over a decade, and they would continue to uphold Europe's ban on direct-to-consumer advertising for prescription drugs.

The proposals follow Commissioner Dalli's announcement in December that the last round of amendments, issued in October 2011, would be split in two to focus on patient information and pharmacovigilance.

They wouldn't allow websites to identify members of the general public who have access to those websites, but they would now be able to contain “web-TV”.

The Commission agrees to pharma companies linking their websites to EU databases and portals on medicinal products, but said it would be more appropriate to link to the forthcoming EU medicines web-portal rather than the EudraPharm database.

The medicines portal, due to come online in July, was established by Regulation (EU) No 1235/2010 and the Commission wants it to become the central point of access to information on medicines.

The plans, outlined last October, are for it to be a network of websites that promote the rational and safe use of medicines and directs users to relevant EU and national websites.

The Commission also proposes:

• Member States shall ensure that marketing authorisation holders register internet websites containing information on medicinal products with the national competent authorities of the Member State of the country code top level domain used by the website concerned, prior to making it available to the general public.

• Where the website does not use a country code top level domain, the marketing authorisation holder shall select the Member State of registration.

• Member States shall ensure that information on medicinal products authorised in accordance with Regulation (EC) No  726/2004 is not made available on Internet websites that they have registered until the information has been approved by the Agency in accordance with Articles 20b and 20c of that Regulation.

The Commission's new proposals, published last week, note: “The internet is of major importance with regard to the provision of information to patients and its importance is increasing. The internet allows almost unlimited access to information disregarding national boundaries.

“Registered websites for objective and non-promotional information are therefore necessary and specific rules on the monitoring of  those websites should be established to take account  of the cross-border nature of information provided over the internet and to allow cooperation between the Member States.”

The Commission's latest proposals will now be discussed by the European Parliament and the Council of Ministers.

• European Commission proposals to amend Directive 2001/83/EC and Regulation (EC) No 726/2004

17th February 2012

From: Marketing


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