Will EMEA solve our problems

1
Will EMEA solve our problems?

• Sharon Frank PhD
• Cordis, Johnson Johnson Medical

2
Objective of this presentation

• Analysis of the question posed overview of the
  following elements
• Problem?
• Solving?
• Agency?

3
Key issues relating to question

• Questions that need to be answered are
• What are the problems that the internal market
  for medical device is facing?
• Can/should they be solved at centralised
  (EC)/decentralised (national) level/cooperation
  MS? Take into account the subsidiarity/proprotiona
  lity principle
• If a centralised structure is the answer, than
  what type of agency, should it be the EMEA with
  its current powers or EMEA revisited?

4
Problems frequently cited

• Borderline products
• Classification issues
• High risk medical devices
• Functioning/Expertise of Notified Bodies
• Vigilance reporting
• Market surveillance
• Various national requirements
• Operating of EUDAMED

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SolveSubsidiary and Proportionality

• Article 5 ECT and Protocol on the application of
  the principles of subsidiarity and
  proportionality annexed to the EC Treaty.
• Intended to ensure that decisions are taken as
  closely as possible to citizens and checks to
  whether action at EC level is justified in the
  light of the possibilities available at national,
  regional or local level.
• EC does not take action unless it is more
  effective than action taken at national, regional
  or local level.
• Closely bound up with the principles of
  proportionality and necessity ( action should not
  go beyond what is necessary to achieve the
  objectives of the ECT).

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Solve problems

• identifying problems
• is the European Community allowed to act i.e is
  there a legal basis in the ECT?
• national or Community level (subsidiarity
  proportionality)

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Will EMEA solve our problems

• Rather than answering the question of EMEA, focus
  on EU agencies
• Reason for creation
• Prohibition delegation of regulatory power
• Types of agencies

8
Why were agencies created?

• Assist in the carrying out of Community
  activities
• Reduce workload of European Commission
• Lack of expertise manpower transparency
  European Commission
• Flexibility day-to-day management
• Most recent document EU agencies The way
  forward COM (2008) 135 final

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Types of agencies

• Executive agencies (formerly TAO)
• Framework Council Regulation (EC) No 58/2003 of
  19 December 2002 laying down the statute for
  executive agencies to be entrusted with certain
  tasks in the management of Community programmes
  (OJ L 11, 16.1.2003).
• Tasks relate to management of Community
  programme
• Created for limited period of time
• Located close to European Commission facility
• E.g. European Agency for Reconstruction (EAR),
  the European Training Foundation (ETF),
  Translation Centre for the Bodies of the EU
  (CdT).
• The literature varies in ways of classifying
  the types of agencies in the EU.

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Types of agencies

• Regulatory agencies
• required to be actively involved in exercising
  the executive function by enacting instruments
  which contribute to regulating a specific sector
• Subdivision is
• decision- making agencies empowered to enact
  legal instruments binding on third parties
  (adjudication)
• E.g. The Office for Harmonisation in the Internal
  Market ( OHIM), the Community Plant Variety
  Office (CPVO), the European Aviation Safety
  Agency, and European Chemicals Agency (the ECHA).
• agencies that have no power of decision towards
  third parties, but perform all other regulatory
  tasks. Commission bases its decision on
  scientific opinion.
• E.g. The European Food Safety Authority (EFSA)
  and the European Medicines Agency (EMEA)

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Types of agencies

• Other regulatory agencies
• Agencies in charge of operational activities
  EAR, GSA, CFCA, FRONTEX, EUROJUST,EUROPOL and
  CEPOL
• Agencies responsible for gathering, analysing and
  forwarding objective, reliable and
  easy-to-understand information / networking
  CEDEFOP, EUROFOUND, EEA, ETF, EMCCDA, EU-OSHA,
  ENISA, ECDC, FRA and European Institute for
  Gender Equality

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Regulatory agencies with rule making powers?

• In 1990 the European Commission stated the
  following in its proposal for the establishment
  of the EMEA
• in accordance with the principle underlying the
  Community treaties, the tasks of the new Agency
  are purely advisory, and it is neither possible
  nor appropriate to delegate to the Agency the
  power to take decisions on the authorisation of
  new medicinal products which would be binding on
  the Community and the Member States. Such
  decisions can only be taken by the Community
  institutions.

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Purely advisory

• EMEA provides Commission with expertise for
  decisions on authorisation
• EMEA is not endowed with adjudication power
• Commission may deviate from the expert opinion of
  the EMEA
• Deviation is considered to be exceptionally
  (Council Regulation 1993/2309)

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Regulatory agencies with rule making power?

• Former Commission President Santer (1997)
• I think that an independent agency, to meet the
  specific needs of the Community, but based on the
  positive aspects of the United States Food and
  Drugs Administration, should be considered
• Former Commission President Prodi (1999)
• advocated the idea of an independent European
• food and drug agency to help win back consumer
  confidence

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Regulatory agencies with rule making powers?

• Former Commissioner Byrne (2000)
• The Food Safety Authority will not be a European
  FDA, but will work in close co-operation with
  national scientific agencies and institutions in
  charge of food safety. Unlike the FDA, and this
  is very important, it will not have discretionary
  regulatory powers. These are entrusted to the
  Commission, the European Parliament and the
  Council of Ministers. We wish to make a clear
  distinction between, on the one hand,
  risk-assessment which has to be based on
  scientific excellence and independence and, on
  the other hand, risk-management which is the
  responsibility of decision-makers who are
  politically accountable to the citizens.

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Delegation of powers?

• Meroni case (Case 9-10/56 Meroni v. High
  Authority)
• the Commission cannot delegate broader powers
  than it enjoys itself
• only strictly executive powers may be delegated
• no discretionary powers may be delegated
• the exercise of delegated powers cannot be
  exempted from the conditions to which they would
  have been subject if they had been directly
  exercised by the Commission, in particular, the
  obligation to state reasons and judicial control
  of decisions
• the delegated powers remain subject to conditions
  determined by the Commission and subject to its
  continuing oversight

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Delegation of powers?Institutional balance (of
power)

• Institutional balance article 7 ECT requires each
  institution to exercise its powers with due
  regard to powers of other institution.
• Delegation of power (legislative, executive,
  judicial) to other bodies than the institutions
  mentioned in article 7 ECT would upset
  institutional balance.

18
Non delegation confirmed

• White Paper on Governance (2001)
• According to the Commission, agencies
• can adopt individual decisions in specific areas
  but cannot adopt general regulatory measures
• cannot be given responsibilities for which the
  Treaty has conferred a direct power of decision
  on the Commission
• cannot be granted decision making powers in
  areas in which they would have to arbitrate
  between conflicting public interests, exercise
  political discretion or carry out complex
  economic assessments.

19
Non delegation confirmed

• Communication from the Commission - The operating
  framework for the European Regulatory Agencies
  (2002)
• The decision-making agencies may adopt
  individual decisions but not legislative measures
  of general application.
• Use of decision-making agencies is restricted to
  areas where a single public interest predominates
  and where they do not have to arbitrate on
  conflicting public interests, exercise powers of
  political judgement or make complex economic
  assessments. These agencies may not be granted
  responsibilities for which the EC Treaty confers
  decision-making power directly on the Commission.

20
Non delegation confirmed

• EP Report on proposal to establish an Agency for
  the Cooperation of Energy Regulators (2008) The
  European Parliament
• understands the importance of the principle of
  institutional balance that the European
  Commission, through Treaty, is charged to
  defend.
• has been aware of the key legal principles set
  out in case law by the European Court of Justice
  in the 1958 Meroni judgement (and other cases)
• that a delegating authority cannot confer on
  another body powers different from those
  possessed by the delegator under the Treaty, and
  not subject to the same duties and
• that it is not possible to delegate powers
  involving a wide margin of discretion between
  many different objectives and tasks, so shifting
  responsibilities and escaping political control.
• On this basis, existing European Agencies have
  been mainly endowed with information and
  coordination tasks, with the ability to exercise
  decision-making powers (with legally binding
  impacts on third parties) being restricted only
  to individual cases.

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Summary

• What are the problems, and do they relate to the
  level of health safety of end users, the
  functioning of the internal market, competition
  rules?
• Is there a legal basis in the ECT for the
  European Community to act?
• If there is a legal basis, test the subsidiarity
  proportionality.
• Should an agency have responsibilities for
  medical devices, i.e. should given aspects from
  the regulatory framework be delegated to an
  agency?
• Which type of agencies?
• Agencies can only be endowed with information and
  coordination tasks and exercise decision-making
  powers (with legally binding impacts on third
  parties) being restricted only to individual
  cases.
• Is the current structure (non-decision making
  agency) of EMEA fit for the functions/tasks to be
  delegated ?