Pharma industry is potential source of information for patients, says EU Commission

The pharmaceutical industry could potentially respond to patient requests for information, but a regulatory framework is needed to ensure its objectivity, a European Commission report suggests.

The report, which is submitted for public consultation until 30 June, looks at EU member states' initiatives in the area of information for patients, particularly on the internet.

Patient information is also the focus of a working group in the Pharmaceutical Forum, which was set up by the European Commission in June 2005. One of the questions the working group is examining is that of direct-to-consumer communication by pharmaceutical companies, which is prohibited for prescription medicines in Europe.

'The pharmaceutical industry has the potential to be an important source of information to respond to the growing demand for more and better information by patients .. provided that there will be adequate rules to ensure reliability, objectivity and quality of information,' the report says.

It points out that the pharmaceutical industry has key information about its products that is only partially made available to patients, in the form of brochures and leaflets.

Patient associations questioned when the report was being drawn up said that the focus should be on availability and quality rather than on the source of the information. Many patient associations consider that the pharmaceutical industry is a legitimate source of product information. However, although this information should be available for patients when they seek it, it should not be provided when there is no patient demand.

Pharmaceutical companies also consider that information should be judged by its quality and not by its source. Companies would like to have the right to produce 'non-promotional' information for patients about their products.

More specifically, the European Federation of Pharmaceutical Industries and Associations (EFPIA) favours the idea of making more information about medicines available on the internet.

The report says that patients are looking for more and more information about diseases and possible treatments and are using increasingly diverse sources, with many using the internet.

Although the document confirms the necessity of a dialogue between healthcare professionals and patients, it also notes that patients are now more involved in decision-making about their health. Informed patients can contribute to reducing healthcare system costs, the report says.

EU-level initiatives have already been taken on product information and transparency. One example is the creation of EudraPharm, a database of medicines authorised in the EU. Another is an initiative to make medicines package leaflets easier for patients to read.

The Commission report also used a 2006 survey of national regulatory agencies in the EU and in Norway, Iceland and Liechtenstein, carried out to gather information on their practices in the provision of information about medicines. It found that initiatives varied greatly from one country to the next, in particular concerning the internet, where some member states had a very strict approach whereas others allowed the public to access more information on the net.

Some countries have public-private partnerships (PPP) that cover information on treatment options or offer guides on specific diseases or therapeutic areas. The industry is actively involved in some of these partnerships.

Most regulatory agencies (79%) mainly use the internet to provide information such as the summary of product characteristics (SPC) or label, package leaflet details and public assessment reports. The EU report notes that it is difficult for the regulatory agencies to constantly update this information. Also, for some populations access to the internet is limited (the elderly) or difficult (people with disabilities).

The Pharmaceutical Forum working group on patient information will make proposals at the pharmaceutical Forum, which will meet for the second time in June 2007.

report

Draft Report on Current Practice with Regard To Provision of Information to Patients on Medicinal Products is available at: ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2007/2007_04/draft_infopatients2007_04.pdf