EMEA publishes Draft Transparency Policy

Drug and Biotechnology Regulatory Agency, EMEA, Publishes a draft Policy on Transparency. The EMEA in its longer term vision indicated that its stakeholders would see over the next few years a gradual and stepwise increase in the Agency’s level of transparency, both in the field of non-product as well as product related activities. In order to achieve this objective the EMEA stated that it would involve its partners and stakeholders in discussions on how to meet the increasing demands of civil society (in particular patients/users of medicines as well as healthcare professionals) for earlier information whilst respecting commercial confidentiality of proprietary information.

Rational and Scope of The EMEA Transparency Policy

Rational

The rationale for the development of an EMEA Transparency Policy is:

• To be able to better address the increasing need for information from civil society
• To provide for more openness on the various activities undertaken by the EMEA (in particular its opinion/decision-making process),

Transparency is a pivotal element in building trust and confidence in the Agency’s operation and in addition it fulfils the right of EMEA stakeholders for impartial and comprehensible information about the medicines regulated by the Agency and their use for the benefit of public and animal health.

Scope

Transparency implies openness, communication and accountability, whilst respecting the protection of both personal data as well as commercially confidential information. The EMEA embraces these concepts in the development of its Transparency Policy. The scope of the EMEA Transparency Policy covers medicines for both human and veterinary use, addressing the particularities of each field. Furthermore, the Policy is not restricted to measures arising from currently applicable Community legislation, but it will provide the Agency’s stand on its level of openness toward stakeholders. It is not limited to the level of transparency applied to documents produced by the EMEA, but it will also address other aspects such as the level of interaction with its stakeholders, including involvement in opinion/decision-making.

Objectives of the EMEA Transparency Policy

Three important objectives have been identified:

1. To apply a more proactive approach towards transparency in the daily operation of the EMEA
   1. Finding the right balance between transparency and protection of commercial confidentiality
   2. Increasing the understanding of activities undertaken by the EMEA, including the Agency’s opinion/decision-making.
   3. Promoting good administrative and regulatory practices
2. To further strengthen interaction with EMEA stakeholders
3. To enhance and promote closer interaction with the NCAs within the frame of the EU Regulatory System Network on transparency related aspects

Proposed Way Forward

Objective 1

• Review the balance between transparency and the protection of commercial confidentiality of proprietary information by redefining the notion of commercially confidential information and subsequently arriving at a harmonised EU view on this topic.
• Gradually improve, once the decision-making process has been concluded, the proactive disclosure of EMEA documents/information throughout the lifecycle of medicines for human and veterinary use
• Improve the visibility of the Agency and undertake efforts to better explain how conclusions are being reached at the EMEA as well as the (scientific) rationale for these conclusions.
• Embed a culture of transparency in the Agency’s operations in order to achieve a consistent approach in the application of the various principles of the EMEA Transparency Policy.

Objective 2

Over the next years the EMEA will further progress existing interactions with civil society representatives (in particular patients, but also healthcare professionals), especially at the level of the EMEA Scientific Committees

Objective 3

Further work in this field will focus on identifying where it would be of benefit for the efficiency of the EU Regulatory System Network to arrive at a harmonised approach on transparency related aspects for medicines regulation throughout a product lifecycle. In addition, efforts should also be directed on achieving as much as possible a consistent implementation across the EU.

Next Steps

The draft EMEA Transparency Policy is subject to public consultation until 25 September 2009. In addition, a 2nd Workshop with EMEA partners and stakeholders on the development of the EMEA Transparency Policy is scheduled to take place at the EMEA on 19 October 2009. Following an analysis of the comments received and subsequent adoption by the Agency’s Management Board, the EMEA will publish the final Transparency Policy.

The document then goes on to give examples of the strategies being pursued, its a good start in a process that should make the EMEA more open and accountable, which is good for all involved.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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