Advances in the stricter rules for safer and affordable medicines

The European Parliament has adopted its position on legislation for strengthening patients' rights regarding the information they receive about the quality of prescription medicines. The Chamber has insisted on shifting the focus of legislation from the rights of pharmaceutical companies to patient's right to receive adequate information.

The aim of legislation on medicines information put forward by the European Commission, which includes a Regulation with aspects to be applied at EU-level, and a Directive on rules for Member States to apply at national level, is to ensure that patients receive objective, unbiased, reliable and non promotional information on prescription medicines.

These two texts were voted by the Parliament and adopted by 564 votes in favour, 41 against and 45 abstentions in the case of Regulation, and 558 votes in favour, 42 against and 53 abstentions in the case of the Directive.

During the process of adoption of such rules, MEPs manage to change the focus of the whole legislation from the rights of pharmaceutical companies to spread information to patients' right to get the information they need and want. The proposal and the contributions made by the Parliament, which will go for discussion to the Council, will improve the quality and quantity of information available to patients.

Overt advertising of prescription medicines is already banned across the EU, but Member States’ varying interpretation of the rules means there can be a fine line between information and commercial promotion. The Parliament stresses that pharmaceutical companies should be able to provide basic information, such as product characteristics, labelling and package leaflets and an accessible version of a drug’s assessment report.

Further to the adoption of these rules, companies should also be allowed to provide certain other non-promotional information, for example on price or packaging changes, but only with the authorisation of the relevant Member State authorities.