The confidentiality arrangements cover human medicines subject to evaluation, or authorised under the centralised authorisation procedure. Medicinal products authorised at national level by the EU Member States, that are subject to official EU arbitration and referrals will also be covered by the agreement. The confidentiality arrangements were established through an exchange of letters (see link below).
The type of information covered will include:
advance drafts of legislation and/or regulatory guidance documents;
scientific advice on product development given to companies to promote innovation;
assessment of applications for marketing authorisations; and
information about the safety of marketed medicines to better protect public health.
According to the European Commission “this cooperation will provide earlier access to information and thus make it easier and quicker to take action to protect public health. Our close relationship will also allow us to tackle technical barriers to trade in medicines and help prevent new barriers occurring.” The outcomes of this agreement for public health are still unclear, however the cooperation of the regulatory agencies is welcomed.
Transparency in pharmaceutical regulation
At the moment, the main concern related to medicines is the transparency of information in pharmaceutical regulation. There is a strong public health imperative for full public access to the research evidence establishing the effectiveness and safety of a medicinal product. One of the key principles enshrined in reforms to EU pharmaceutical legislation introduced in 2003 was improvement in transparency of procedures and decision-making.
The provisions for transparency in pharmaceutical regulation allow for an exception to be made for commercially confidential information. From a public health perspective, it is crucial that the definition of commercial confidentiality be explicitly limited to information that is unrelated to a product’s safety and effectiveness, or more broadly to any scientific evidence of its effects on the human body.
Letter from EC and EMEA
EMEA press release
EPHA’s related sections:
EU Pharmaceuticals Review
Pharmaceuticals and Medical Devices
