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Pharmacovigilance - Major developments

Strategy to Better Protect Public Health by Strengthening and Rationalising EU Pharmacovigilance

20 February 2012
Questions and answers on transitional arrangements concerning the entering into force of the new pharmacovigilance provisions in July 2012
(25 KB)With the entering into force of the new pharmacovigilance provisions (Regulation (EU) No 1235/2010 and Directive 2010/84/EU) only a few months away, this Q&A documents addresses questions that have been raised to the Commission as regards the correct phasing-in of the new requirements and the specific dates from which the new rules apply. It is intended to facilitate the preparatory work of all stakeholders involved.

10 February 2012
Information to patients and Pharmacovigilance - New developments

On 10 February 2012, the Commission adopted:

The adoption of these proposals follows Commissioner Dalli' s announcement on 2 December 2011 at the Council on Employment, Social Policy, Health and Consumer Affairs (EPSCO) of the split of the amended proposals on information to patients, which were adopted on 11 October 2011, into two parts relating to "Information to Patients" and "Pharmacovigilance" respectively. The split of the proposals aims to facilitate the discussion of the proposals by the co-legislators. The proposals on Pharmacovigilance seek to to address some weaknesses identified in the EU pharmacovigilance system.
The four proposals will be now discussed by the European Parliament and the Council of Ministers.

9 February 2012

Responses to the Public consultation on the concept paper on implementing measures for the performance of pharmacovigilance activities

A summary of the responses is here(52 KB)

Public responses to the above mentioned public consultation

8 September 2011

Public consultation on a concept paper on implementing measures for the performance of pharmacovigilance activities

In order to harmonise the performance of the new pharmacovigilance activities introduced by the amended pharmacovigilance legislation (cf. Regulation (EU) No 1235/2010 and Directive 2010/84/EU) the Commission shall adopt several implementing measures. Those measures supplement essential details of the new pharmacovigilance system with the more technical details that have to be observed by marketing authorisation holders, national competent authorities and the European Medicines Agency in the daily practice of applying the new provisions.
With the public consultation the European Commission intends to describe the scope and content of the implementing measure which it is currently considering and seeks views and feedback from stakeholders on those issues. A more detailed description can be found in the concept paper(109 KB).

The period of consultation ends on 7 November 2011. All citizens and organisations (public and private) are welcome to contribute to this consultation. For more information on how to contribute, please read the concept paper.
Received contributions will be published on the internet. For more information on the processing of personal data in the context of this consultation, read the specific Privacy Statement(16 KB).

22 September 2010

Statement by John Dalli, European Commissioner for Health and Consumer Policy, on EU legislation on Pharmacovigilance

The European Parliament today voted in favour of the EU legislation on pharmacovigilance

Reacting to the vote, Commissioner John Dalli said: "I welcome today's vote by the European Parliament which formalises the agreement reached during the Spanish Presidency and I thank the Rapporteur, Mrs McAvan, for her excellent work. Today's vote is good news for Europeans as the legislation will ensure greater patient safety and improved public health. In addition, by better focussing the work of public administration and industry, red tape shall be cut. Once implemented, the new legislation will strengthen and modernize the current system for monitoring medicinal products for human use in the EU, making it more robust and transparent".

Once medicines are authorised and enter the market, they continue to be monitored through the EU system of pharmacovigilance. This is to prevent, detect and assess possible adverse effects. The reporting of adverse drug reactions is essential for effective pharmacovigilance and under the new legislation patients can report adverse drug reactions directly to the competent authorities.

For more information please visit:
http://ec.europa.eu/health/human-use/pharmacovigilance/index_en.htm

5 February 2009

The Commission services wish to consult stakeholders on the Recommendation on "Pharmacovigilance Urgent Measures" procedure under Article 107 of Directive 2001/83/EC, with a view to the incorporation of the guidance in Volume 9A in Eudralex.
The public consultation document is here(42 KB) .

Contributions should be sent by e-mail to sanco-pharmaceuticals@ec.europa.euby 3 April 2009.

10 December 2008

In 2006 the European Commission consulted the public and its stakeholders on the current pharmacovigilance system. Based on the results of the public consultation, on 26 February 2007 Commission Vice-President Günter Verheugen announced a strengthening of the EU's pharmacovigilance system.

On 10 December 2008 the Commission adopted two legislative proposals, as part of the pharmaceutical packageaimed at amending the current legal framework.

The proposals focus on but are not be limited to:

Maintaining the current split of competences between the Member States and the EMA, while making clear the respective roles and responsibilities and minimising the duplication of effort.
Strengthening the rules on transparency relating to pharmacovigilance data, assessment and decision-making and involving stakeholders (e.g. patient and health care professional groups) in the processes, including reporting (including patient reporting).
Establishing clear standards ('Good Vigilance Practices - GVP') for the conduct of pharmacovigilance by both the industry and the regulators.

Freeing up resources by rationalising and simplifying the reporting of suspected adverse drug reactions (ADRs), both expedited and periodic reporting, making the best use of current information technology (including Eudravigilance) and matching the reporting requirements with the level of knowledge about the safety of a specific product. The focus will also be on stimulating innovation, by establishing a clear legal requirement to conduct post-authorisation safety studies, including those in risk management systems.

The current EU System

The current EU pharmacovigilance system is organised with functions, responsibilities and accountability shared between the Member States' competent authorities, the European Medicines Agency (EMA) and the European Commission. The EMEA has responsibility for co-ordinating the pharmacovigilance activities of the Member States.
The exact division of responsibilities among the parties involved changes depending on how a particular medicine is authorised. If a medicine has been authorised through the national authorisation mechanisms, most (but not all) of the functions, responsibilities and accountability for pharmacovigilance rest with the Member States. In contrast, for centrally authorised medicines, that is, those authorised through the central Community authorisation procedure, more of the functions, responsibilities and accountability for pharmacovigilance fall to the EMEA and the European Commission.

Why we need to improve the EU's pharmacovigilance system

Pharmacovigilance is a key public health function and there is a need to strive to ensure it is optimally effective. The current system of pharmacovigilance in the EU is complex and there is potential for duplication of effort, as well as the potential for confusion of responsibilities. This is particularly true now with the introduction of innovative products, some utilising innovative technologies. Furthermore, with globalisation of the pharmaceutical market, products often enter different global markets simultaneously, with the exposure of large numbers of patients occurring in a short period of time.
Our society is changing and the expectations of EU citizens are also changing. There is a need to ensure that our pharmacovigilance systems are robust but also transparent, and we need to consider the appropriate level of involvement in the system of different stakeholders, including health care professionals and patients.
Although evolving over time, the current system of pharmacovigilance in the EU has been established for a number of years and it is an appropriate time to improve it.

The European Commission adopts two legal proposals aimed at amending the EU pharmacovigilance system.

Press release

Summary of the proposals(15 KB)

Brief background information(53 KB)

Text of the proposal (Directive)

Text of the proposal (Regulation)

Impact assessment : volume 1(387 KB) - volume 2(316 KB)

Executive summary of the Impact assessment

Commission Pharmacovigilance Strategy: results of public consultation on draft legislative proposals

Between 5 December 2007 and 1 February 2008 the European Commission services consulted stakeholders on legislative proposals to strengthen and rationalise the EU system of pharmacovigilance.

An analysis of the consultation results can be found here(134 KB)
The individual consultation responses can be found here

Commission Pharmacovigilance Strategy: Public consultation on draft legislative proposals (5 December 2007 - 1 February 2008)

DG Enterprise and Industry of the European Commission wishes to consult stakeholders on legislative proposals to strengthen and rationalise the EU system of pharmacovigilance. All comments should be sent electronically to Dr Peter Arlett (sanco-pharmaceuticals@ec.europa.eu ) by 1 February 2008. The consultation document can be found here(257 KB).

Announcement of February 2007

Based on the results of the public consultation of 2006 (see below), on 26 February 2007 Commission Vice-President Günter Verheugen announced a strengthening of the EU pharmacovigilance system. The announcement is based on the results of the 2006 public consultation and includes both better implementation of the current system and proposals to change the legal framework for pharmacovigilance in the EU. The change to the legal framework will involve an impact assessment during the course of 2007 with a view to a legal proposal in 2008.

Current rules on pharmacovigilance:

click here for legislation
click here for guidelines.

Commission Public Consultation 2006:
An Assessment of the Community System of Pharmacovigilance

The Commission today launches a public consultation on the Community system of pharmacovigilance. The objective of the consultation is to collect the views of stakeholders on the community system, including comments on the current functioning of the system and how it might be further strengthened.

A document to explain the consultation and its background is available here(2 MB).

A template for your consultation responses is available here.(19 KB)

Electronic consultation responses are preferred and should be sent to sanco-pharmaceuticals@ec.europa.eu . Please note that your consultation response will be made public.

The Commission will be holding two workshops in April or May 2006 as part of the public consultation. One will be for patient groups and healthcare professionals, the other for the pharmaceutical industry. Places will be limited and we cannot guarantee to accommodate everyone that would like to attend but if you would like an invitation please email your name, the organisation you represent and all relevant contact details to sanco-pharmaceuticals@ec.europa.eu . As places are limited priority will be given to European organisations. All requests for the workshops should be sent by 31 March 2006.

This consultation is one key way that we can ensure that we strengthen pharmacovigilance, making it fit for the enlarged Community for decades to come and hence effectively protecting the health of citizens in the EU and beyond.

Pharmacovigilance

European Commission Public Health