New framework for provision of information to the general public about prescription-only medicines
We have followed the development and reported on proposals for amendments to EU legislation relating to prescription-only medicines ("POMs") in our life sciences and healthcare bulletin InFocus. In this context it has been the European Commission's aim to provide a clearer framework for the provision of information to the general public by marketing authorisation holders about their POMs and enhance the rational use of these medicines while continuing to prohibit direct-to-consumer advertising of POMs. On 11 October 2011 the Commission presented its amended proposals which are discussed below.
Background
In 2007 a European Commission report found that Member States each interpreted differently what constituted the lawful provision of information about POMs to the general public. The resulting discrepancies led to a huge difference in access to, and quality of, information available to EU citizens living in different EU Member States.
In order to address this problem and provide more harmonisation, proposals on a clearer framework were published by the Commission in late 2008. These were subsequently passed down to the European Parliament, where MEPs sought to re-balance the perceived focus of the proposals by stressing patients' rights to the information they wanted, rather than the rights of pharmaceutical companies to disseminate information on their products.
Mandatory and optional information categories
Under the amended proposals to Directive 2001/83, the content of information on POMs will be limited to two categories, information that must be made available ("Category 1") and information that may be made available ("Category 2") by market authorisation holders.
Category 1
- The most recent summary of the product characteristics as approved by the competent authorities;
- the most recent labelling and package leaflet as approved by the competent authorities; and
- the most recent publicly accessible version of the assessment report as drawn up by the competent authorities.
Category 2
- Information on the environmental impact of the product;
- information on prices;
- information on and factual, informative announcements and reference material;
- information relating to pack changes;
- information on the instructions for use of the medicinal product, in addition to the information already contained in the mandatory documents;
- information on pharmaceutical and pre-clinical tests and clinical trials;
- a summary of frequently submitted requests for information and the answers to such requests; and
- other types of information approved by competent authorities for the proper use of the POM.
Generally, information which has not previously been approved must be reviewed and cleared by the competent authority before the marketing authorisation holder can make it available to the general public. The proposals do allow for some exceptions to this rule where other mechanisms exist to control the information after it has been made available to the general public. Member States must ensure that any information is subject to strict qualitative requirements ("the Qualitative Requirements"). This means information must be unbiased, evidence-based, factually correct and understandable and meet the expectations and needs of patients.
Limited channels of communication
The amended proposals continue to limit the channels of communication for pharmaceutical companies. Officially registered websites (i.e. information websites that are registered with the competent authority of the Member State in question) are envisaged as a step towards ensuring that web-based information meets the Qualitative Requirements and does not confuse patients. Printed information provided by pharmaceutical companies will be acceptable if specifically requested by a member of the public. However, the amended proposals remain opposed to information being forced upon patients, so that in general information on POMs must not be disseminated via mass-media, for instance on tv, radio, in newspapers or magazines.
An express exception to this relates to vaccination campaigns by the industry. However, it should be noted that the vaccination campaign in question must first be approved by the competent authority and that any information disseminated as part of a campaign must refer to the vaccines in question and not to the diseases concerned. Furthermore, the amended proposals delete any reference in this respect to "other campaigns in the interest of public health" (which had been included in the previous draft amendments), so that the exception remains extremely narrow indeed.
Pharmacovigilance strengthened further
The amended proposals also seek to modify legislation to provide for an automatic procedure at European level where serious safety issues arise in connection with nationally authorised POMs. The proposed changes are designed to ensure that any such issues are assessed and resolved in all Member States where the POM is authorised. Equally, the proposals seek to safeguard against a situation whereby the voluntary withdrawal of a marketing authorisation or a product by the holder leads to safety issues not being addressed in the EU.
Next steps
The amended proposals in relation to Directive 2001/83 are now subject to further scrutiny by the European Parliament and the Council of Ministers. Any progress in the decision making process will be published by the European institutions once a workable time table has been agreed.
Lawyers Tim Worden
