European Forum for Primary Care
Response to the consultation on the legal proposal on information to patients
April 5, 2008
To:Commissioner Günter Verheugen
European Commission
200, Rue de la Loi
B-1049 Brussels (Belgium)
Commissioner Androula Vassiliou
European Commission
200, Rue de la Loi
B-1049 Brussels (Belgium)
- The rational of prescription-only drugs is that the use of these medicines needs to be restricted for reasons of effectiveness, safety and – in many cases – costs. During consultation, a licensed practitioner helps the patient by assessing the health needs of the patient and placing them in the context of personal history, work, family and community. Then, with the patient, treatment options are considered and finally a decision is taken for the optimal drug regimen – if any. During this decision process, factual information on medicines is just one of the many elements to consider. A key issue is that patients need balanced information on treatment options and not just on individual products (medicines). Unsolicited information on medicines or on one medicine is disruptive in this process, as experiences in New Zealand and the USA have shown.
- While many patients are sufficiently health literate and able to make their own judgments, many others are not and these persons should not be confronted with unsolicited information (TV, radio, newspapers etc) on prescription drugs – the importance and relevance of which they are not able to assess. Also, judgment by patients is very much situation related. Evidence abounds that even well educated and informed patients lose their independent judgment – temporarily or for a longer period of time - when confronted with health problems that seriously impact on their life or autonomy. In these situations, the patient’s critical assessment of information that is provided by industry or any other source often is affected and unsolicited information can be destabilising and add to the uncertainty of the patient.
- Since in many EU countries 80 % of drugs are prescribed in primary care, at this level pressure on the consultation process would be strongly felt – and the negative effects most prominent.
- The very basis of the proposal has to be questioned: information, to be provided by industry, that is objective and unbiased (the quality criteria mentioned in paragraph 4 of the proposal) does not exist, because the main criteria for the selection of the information to be provided to the public are marketing considerations, i.e.a company will only provide information on the products it has onsale.
Recently, several publications have highlighted the fact that industry and industry related researchers may choose to omit information that is unfavourable for the marketing of particular medicines. This underlines the fact that information in itself is not neutral or free of bias.
The full definition of advertising, Article 86 of Directive 2001/83/EC:
For the purposes of this Title, ‘advertising of medicinal products’ shall include any form of door to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products; it shall include in particular:
- the advertising of medicinal products to the general public,
- advertising of medicinal products to persons qualified to prescribe or supply them,
- visits by medical sales representatives to persons qualified to prescribe medicinal products,
- the supply of samples,
- the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal,
- sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products,- sponsorship of scientific congresses attended
by persons qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith.
- The difference that is made between advertisement and information is artificial, which is clear from the definition of advertisement itself. Also, where companies offer a financial incentive or payment for information on their products to be presented in any form, this is advertising. Therefore, the second policy objective in the proposal Maintaining the ban on direct-to-consumer advertising of prescription medicines,making sure that there is a clear distinction between advertising and non promotional informationis intrinsicallyirrelevant.
- We do not support harmonization of practices on information to patients in the EU in the sense as proposed here, since information to patients is and should be embedded in the health systems and cultural backgrounds – that differ so much between the EU member states. An example is the widely differing attitudes of the public towards drugs prescription and drugs consumption in the member states, varying from strong pharmaco-centrism to drug-reluctance[1]. Harmonization of information practices does not lead to benefits for patients.
- We would welcome support to member states in developing good practice in the field of quality assurance in health related information to patients ánd professionals. The open method of coordination would be an appropriate instrument.
- Many patients are experts in the field of their own disease – especially when the disease is a chronic one. They also accumulate expertise on the drugs that they use. These patients are a valuable source of information and various EU co-funded projects have researched how this information source can be used to the benefit of fellow patients. We propose that the Commission (DG Enterprise and DG Sanco) would pursue this route of providing information that benefits patientsand, hence, is demand driven, rather than trying to involve industry.
- We suggest that issues related to public health and health care are dealt with by DG Sanco or at least in public and explicit consultation with DG Sanco, so as to maintain a coherent public health approach in the EU. Concretely, we would like to see that DG Enterprise submits any proposal dealing with information to patients in conjunction with DG Sanco.
The European Forum for Primary Care is a network of more than 100 organisations and individuals in Europe – and beyond. The aim of the Forum is to improve the health of the population by promoting strong Primary Care. In the Forum, practitioners, policy makers and researchers share experiences, views and information.
[1] Europeans and their Medicines; a cultural approach to the utilization of pharmaceuticals, 2004;
S Kooiker and L van der Wijst, SCP-GfK Panelservices Benelux; ISBN 90-9017709-4