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Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.
Pharma companies must ensure that patients have access to "objective, unbiased information" about medicines, according to MEPs of the European Parliament?s Health Committee — this should be a patient right rather than an option for pharma companies.
Pharma companies must ensure that patients have access to “objective, unbiased information” about medicines, according to MEPs of the European Parliament’s Health Committee this should be a patient right rather than an option for pharma companies.
This issue was raised earlier this week when MEPs voted on the element of the EC’s 2008 ‘Pharmaceutical Package’ concerning improving patient access to health and medicines information. The basic aim of the draft legislation is to ensure that good quality and reliable medicines information is available. In the draft proposal issued by the EC, pharma companies would have had the option of making available unbiased medicines information.
In this week’s vote, however, MEPs introduced a new article into the legislation that would require pharma companies to make available the most recent summaries of product characteristics and labeling and package leaflet, as well as a publicly accessible version of the assessment report. Companies would also have to state which diseases and health conditions can be treated with the medicine and provide information on how to prevent these. Member states would also be obliged to ensure that information is available to the general public on all medicinal products sold within their respective borders.
In addition, pharma companies would also have the option of providing public access to other “well-defined non-promotional information” such as the environmental impact of the product, or instructions for use (which would require prior authorisation from the competent authorities).
The information would have to be supplied in both electronic and printed form, as well as in formats for the blind and partially-sighted. However, companies would not be allowed to disseminate information via radio or television broadcast. Printed material would only be sent to members of the public at their specific request and would not be published in newspapers or magazines.
The vote has been noted by the European Federation of Pharmaceutical Industries and Associations (EFPIA), which commended the European Parliament for its “pragmatic approach” to the proposals in a statement. The suggestion of disseminating medicines’ information to patients has caused controversy in a number of member states, with some reluctant to even discuss the issue. However, “such an approach ignores the reality of the modern information society, and perpetuates inequalities of access to information that currently exists between member states”, according to Brian Ager, Director General of EFPIA.
EFPIA believes that the vote is a step in the right direction, but also warns that to be effective any new legislation must also provide a viable legal framework. “It should build on existing best practice within the EU, and not introduce costly and unnecessary bureaucracy, delivering neither real benefit in the quality of information nor public health gains,” warned Ager.
EFPIA says it has already made “concrete” proposals for a reform of the current situation, including a set of quality criteria to distinguish information from advertising along with a Europe-wide code of practice.