Documents considered by the committee on 10 November 2010, including the following recommendation for debate: Safety of offshore oil and gas activities - European Scrutiny Committee Contents

8   Pharmacovigilance of medicinal products for human use




COM(08) 665




COM(08) 664

+ ADDs 1-3

Draft Directive amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use

Draft Regulation amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No. 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

Commission staff working documents: impact assessment and summary of assessment

Legal base(Both) Article 95 EC; co-decision; QMV
Document originated(Both) 10 December 2008
Deposited in Parliament(a)  12 January 2009

(b)  22 December 2008

Basis of consideration(Both) EM of 14 January 2009 and Ministerial letters of 20 May 2009, 19 November 2009, 18 March 2010 and 25 October 2010
Previous Committee ReportHC 19-v (2008-09), chapter 8 (28 January 2009)
To be discussed in CouncilPossible adoption in November
Committee's assessmentPolitically important
Committee's decisionCleared


8.1  In order to ensure the quality, safety and efficacy of medicines, medicinal products require a marketing authorisation before they may be placed on the market. In 2001, the Council adopted a Directive laying down procedures for Member States to authorise and supervise the marketing, manufacture, importation and wholesale distribution of medicinal products for human use. An authorisation given by a Member State or States in accordance with the Directive is valid only in that State or States.

8.2  In 2004, the Council adopted a Regulation establishing procedures for the authorisation and supervision of certain medicinal products intended for human and veterinary use by the Commission. An authorisation made in accordance with the Regulation is valid throughout the EU.

8.3  Pharmacovigilance — the process for monitoring and assessing the risks and benefits of medicines and for taking remedial action if needed (such as suspension of a marketing authorisation) — is a central element of both measures. In December 2008, the Commission proposed amendments to the 2001 Directive and 2004 Regulation which were intended to strengthen the protection of public health and patient safety, cut red tape, and improve the operation of the internal market for medicines. Document (a) amends the pharmacovigilance provisions of the 2001 Directive and document (b) the corresponding provisions of the 2004 Regulation.

Previous scrutiny

8.4  Our predecessors considered the amendments proposed in documents (a) and (b) on 28 January 2009. The Committee's Report[17] set out the main provisions, which were to:

  • repeal the pharmacovigilance chapters of the 2001 Directive and 2004 Regulation and replace them with new chapters;
  • clarify the responsibilities of Member States, the European Medicines Agency and the holders of marketing authorisations;
  • create a new Pharmacovigilance Risk Assessment Advisory Committee ("PRAC") to provide support to both the Committee for Medical Products for Human Use (which assists the European Medicines Agency by giving opinions on the safety, quality and efficacy of medicinal products) and Member States;
  • strengthen the EU's Adverse Drug Reaction Database (the EudraVigilance database), which would become the single point of receipt for all pharmacovigilance information about medicinal products for human use authorised in the Community;
  • give the European Medicines Agency responsibility for coordinating communication between Member States about major new concerns about the safety of active substances authorised by one or more Member States;
  • introduce a new "key information" section into the summary of the product's characteristics which appears in the leaflet which accompanies every medicinal product;
  • simplify the present requirements for a detailed description of the pharmacovigilance system to accompany applications for marketing authorisation;
  • require applicants for authorisation to provide a risk management system for their products;
  • simplify the obligations of holders of marketing authorisations to report adverse reactions to medicines ("adverse drug reactions") and require Member States to submit to the EudraVigilance database adverse reports by patients and healthcare staff;
  • simplify the requirements for holders of marketing authorisations to produce periodic reports to update the information about the safety of products ("periodic safety update reports"); and
  • strengthen the arrangements for Member States and the European Medicines Agency to assess and follow-up periodic safety update reports.

8.5  The Commission estimated that the total net saving to companies and regulators if the proposals were adopted would be about €140 million a year and that between 591 and 5,910 deaths would be avoided each year.

8.6  The previous Government indicated broad support for the Commission's proposals but highlighted two issues: further information would be needed on the precise role and responsibilities of the new advisory Pharmacovigilance Risk Assessment Committee (PRAC); and the EudraVigilance database would have to be compatible with and linked in to national databases on adverse drugs reactions. Our predecessors also welcomed the aims of the Commission's proposals but, as they were complex and detailed, asked the then Minister for progress reports on the negotiations and kept both documents under scrutiny.

8.7  Progress reports since then have continued to focus on PRAC, with the Government seeking to ensure equal representation of Member States on the Advisory Committee, and on the need to ensure that the development of EudraVigilance as a single point of receipt for adverse drug reactions does not undermine the UK's own comprehensive database.

The Minister's letter of 25 October

8.8  The Parliamentary Under Secretary of State (Anne Milton) explains that significant progress was made under the Spanish Presidency, culminating in political agreement on compromise Presidency texts at COREPER (the Committee of Permanent Representatives to the EU) in June. As both documents were under scrutiny at the time, the Minister says that the Government abstained on the vote in COREPER. She expects that the texts agreed in June will be proposed for formal adoption by the Council in November.

8.9  The Minister sets out the main features of the agreed texts as follows:

  • equal representation of Member States (supplemented by additional experts) on the Pharmacovigilance Risk Assessment Committee and clarification of its relationship with other EU Committees;
  • streamlining of reporting of adverse drug reactions, so that drug companies need only submit reports to EudraVigilance, but with guarantees to ensure that the relevant Member States will have immediate access to these reports to enable them to continue to monitor medicines used in their domestic markets;
  • introducing a risk-based approach (reducing administrative burdens) for the production of Periodic Safety Update Reports by drug companies;
  • greater opportunities for national regulatory authorities to work together to reduce the cost of regulation;
  • greater use of risk management plans, especially for new medicines, to assess and monitor risks arising from the use of medicines;
  • greater legal clarity about the obligations on drugs companies to report adverse reactions arising from the use of medicine, whether use is in accordance with the relevant licence or not;
  • new regulatory procedures, for example, to ensure that patients taking new medicines know that they are under additional monitoring, or to restrict the use of a medicine if risks are identified that require further investigation.

8.10  The Minister explains that the agreed texts also reflect changes resulting from the entry into force of the Lisbon Treaty last December. First, the legal base has been amended to cite Treaty Articles in the Treaty on the Functioning of the European Union (TFEU) and now includes Article 168(4)(c) — which provides for measures setting high standards of quality and safety for medicinal products — as well as Article 114 on the approximation of national laws for the purpose of the establishment and functioning of the EU's internal market. The Minister says that, previously, medicines legislation only cited an internal market legal base but the addition of Article 168(4)(c) has no implications for EU competence.

8.11  Second, Article 290 TFEU provides for EU legislative acts to delegate power to the Commission "to supplement or amend certain non-essential elements of the legislative act". Document (a) — the draft Directive — now includes provision for the Commission to adopt delegated acts setting out detailed rules for pharmaceutical companies on the minimum requirements needed to ensure compliance with the pharmacovigilance provisions of the draft Directive and clarifying the situations in which they are required to undertake efficacy studies after a medicine has been authorised. The Minister believes that the powers delegated to the Commission are "appropriately framed" and says that the Government is "content that Member State experts will be consulted when the guidance is drawn up".

8.12  The Minister asks us to clear the draft Directive and draft Regulation from scrutiny to enable the Government to lift it parliamentary scrutiny reserve on both proposals and support the adoption of the Presidency compromise texts at a forthcoming Council in November.


8.13  We note that the Presidency compromise texts address the principal concerns raised by the Government in the course of negotiations. In particular, the texts secure equal representation of Member States on the new advisory Pharmacovigilance Risk Assessment Committee and ensure that the reporting of adverse drugs reactions via a centralised EU database — EudraVigilance — will not undermine the efficacy of the UK's own database. We agree with the Government that the addition of Article 168(4)(c) TFEU to the legal bases cited for the proposals does not represent an extension of EU competence.

8.14  The changes contained in the amending Directive and Regulation will not fundamentally affect existing procedures for authorising or suspending the marketing of drugs. While we are content to clear both documents from scrutiny, we do so subject to the following observation. We anticipate that pharmaceutical companies will increasingly use EU procedures to obtain EU-wide authorisation to market their drugs in all Member States. While this may reduce the regulatory burden on companies, this should not be at the expense of public health protection. We note that the 2004 Regulation provides, in recital 13, that where a drug has been authorised at EU level, Member States should be able "exceptionally to prohibit the use in their territory of medicinal products for human use which infringe objectively defined concepts of public policy and public morality." We wish, therefore, to emphasise the need for national regulators to exercise vigilance and to act quickly and decisively if safety concerns about the use of a drug authorised at EU level emerge within their own territories, including by invoking, where necessary, the public policy safeguards contained in Article 114(4) TFEU.

17   See HC 19-v (2008-09), chapter 8 (28 January 2009).  Back

previous page contents next page

House of Commons home page Parliament home page House of Lords home page search page enquiries index

© Parliamentary copyright 2010
Prepared 23 November 2010