Brussels, 11 October 2011
The European Commission
released today its revised proposal on ‘Information to Patients' which looks at
different ways of providing information on prescribed medicines and the role of
the pharmaceutical industry in providing such information on their products
directly to people.
According
to the proposals adopted by the European Commission, the pharmaceutical
industry would have to be more clear and concise with the information it
provides to the public with regard to prescription-only medicines. These
proposals include a series of requirements related to the kind of information
that would be allowed, the communication channels, as well as quality criteria
and pharmacovigilance issues.
The
Commission's
proposals focus on providing higher protection to patients, by obliging the
pharmaceutical industry to provide essential information about prescription
medicines and by establishing clear rules for any additional information
provided voluntarily. As highlighted by European Commissioner for Health and
Consumer Policy, John Dalli, they are also meant to strengthen the control of
authorized medicines by prioritizing the rights, interests and safety of
patients.
These
revised proposals adopted by the Commission represent an amendment to those
already put forward in 2008 within the package for the improvement of
innovation, safety and accessibility to medicines. Among the new rules, the
Commission proposes that only certain information on prescription-only medicines would be made
public. This
information would includes, i.e., the information included in the label and
packaging, the price of the medicines, or information clinical trial which is
already publicly available through the European Registry of Drug Clinical Trials
launched by the European Medicines Agency in March 2011.
The
proposals also include that information about prescription medicines would only be disseminated
through certain channels of information. This is to ensure that the information which reaches the patient
is as reliable as possible, ensuring that the information which can be found on
channels such as Internet is accurate and safe. It would also be required that
this information
meets recognized quality criteria in terms of fairness and
clarity, as well as to be based on evidences and not being misleading.
Finally,
the new Commission proposals would establish that, in general terms,
information which has not been previously approved must be verified by the
competent authorities before release. Furthermore, these proposals are meant to
improve the current system of pharmacovigilance
in the European Union.