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Decision in case 1267/2017/PL on the European Commission’s failure to decide on the legality of the suspension by French and Belgian authorities of the market authorisation of a medical device

Dostępne języki :  en
  • Sprawa :  1267/2017/PL
    Otwarta 2017-08-08 - Decyzja z 2018-04-05
  • Dotyczy(Dotyczą) instytucji :  Komisja Europejska

The case concerned the fact that the European Commission has yet to decide on the legality of the suspension by the French and Belgian authorities of the market authorisation of a particular medical device. The complainant is the manufacturer of the device.

The Ombudsman inquired into the issue and found that the Commission has been actively working on the file since October 2016. The consultation process is still ongoing and the Commission, at the request of the complainant, held a meeting with all the parties concerned in February 2018.

Given that there has been no indication of possible maladministration in the Commission’s on-going handling of the suspension by the French and Belgian authorities of the market authorisation of the device, the Ombudsman has decided to close the case.

Background to the complaint

1. The complainant is a French laboratory that manufactures the medical device[1] in question. In August 2016, the French authorities suspended the market authorisation of this product on the grounds that it contained potentially harmful levels of lead. The Belgian authorities took a similar decision in October 2016.

2. According to the procedure laid down in the Directive concerning medical devices[2], when a Member State suspends the market authorisation of a product on the grounds that it puts consumers’ health at risk, it must immediately inform the Commission. The European Commission must then enter into consultation with the parties concerned, as soon as possible, to decide whether the measure is justified.

3. In this case, the French authorities informed the European Commission of the suspension of the market authorisation on 4 October 2016. On 26 October 2016, the Commission contacted the complainant and met with it in December 2016. Following this meeting, the two parties engaged in lengthy correspondence.

4. In June 2017, the Commission informed the complainant of its preliminary assessment that the measure of the French authorities was justified.

5. In July 2017, the complainant, unhappy with the time it was taking the Commission to take a final decision, turned to the Ombudsman.

The inquiry

6. The Ombudsman opened an inquiry into the allegation that the Commission was failing to fulfil its duty under the medical devices Directive by not taking a decision on the suspension of the market authorisation in France and Belgium of the device in question.

7. In August 2017, the Ombudsman contacted the Commission and invited it to inform the complainant of its formal decision as regards this issue, or at least of when it would be in a position to take such a decision. The Commission replied that there were ongoing exchanges with the complainant and the relevant national authorities, and that as a result it was not yet in a position to take a decision.

8. In January 2018, the Ombudsman inspected the Commission’s documents in the relevant file with the purpose of obtaining a comprehensive overview of the work and consultations the Commission had carried out thus far.

9. The Ombudsman's decision takes into account the arguments and views put forward by the parties.

Arguments presented to the Ombudsman

10. The complainant argued that after months of exchanges of correspondence and views with the Commission, the Commission had gathered enough information to be able to take a decision on whether the suspension of the market authorisation by the Belgian and French authorities was justified.

11. In the course of the Ombudsman’s inquiry, the Commission and the complainant continued corresponding. This correspondence included a discussion on the substantive points raised by the complainant, in particular the applicability of the ICH Q3D referential[3] to a medical device. The Commission also informed the complainant that its preliminary assessment led it to believe that the suspension of the market authorisation was indeed justified; however taking a formal decision still required a complex internal assessment and further consultations of several departments of the Commission.

12. The Commission said that its decision-making process needed to take into account also all the new information that was added to the file, among others by the complainant itself. In that regard, the Commission referred, by way of example, to the report which the complainant had sent to the French authorities in August 2017[4] and which had led to a new exchange of views between the complainant and the French authorities.

13. Finally, the Commission informed the Ombudsman that, following the complainant’s request of 26 October 2017, it had decided to organise a meeting involving all parties concerned that is, the complainant and representatives from the French and Belgian competent authorities.

14. The complainant contacted the Ombudsman several times throughout the inquiry to reiterate its disagreement with the overall time it was taking the Commission to take a decision. It also raised several new concerns regarding the way the Commission was conducting the ongoing consultation; it also argued that the Commission should invite more parties to the meeting scheduled for February 2018 with the parties concerned.

The Ombudsman's assessment

15. The so-called ‘safeguard clause’ in the medical devices Directive provides that when a Member State informs the Commission of the withdrawal of a product from the market, the Commission must enter into consultation with the parties concerned, as soon as possible. The objective of this consultation is to decide whether the measure is justified.

16. In this case, the Commission contacted the complainant, twenty-two  days after it was informed by the French authorities of the interim measures adopted against the marketing of its device. The Commission did not contact the French authorities immediately. It then contacted the French authorities in April 2017.

17. From the inspection of the Commission’s file it appears that at the time the complainant turned to the Ombudsman (July 2017), the Commission was already engaged in regular correspondence both with the complainant and the French authorities and continued to do so during this inquiry.

18. The file also shows that since September 2017, the Commission has been actively conducting internal consultations with a view to making a final decision on this matter.

19. Moreover, the Commission appears to have made a genuine effort to organise the meeting requested by the complainant to which both the French and Belgian authorities were invited, as a means to address, in full transparency and fairness, all the outstanding issues that, once clarified, should enable the Commission to take its decision.

20. Therefore, far from being idle in this case, or delaying unnecessarily the procedure leading to the adoption of a decision, the Commission has genuinely engaged in regular consultations with all the parties involved and has actively sought to address issues which are material for taking a decision in conformity with the requirements of the Directive. Thus although the time taken has been  regrettably long - a fact also recognised by the Commission - the inquiry has not brought to light any instance of maladministration,

Conclusion

Based on the inquiry, the Ombudsman closes this case with the following conclusion:

There is no maladministration by the European Commission.

The complainant and the European Commission will be informed of this decision.

 

Emily O'Reilly

European Ombudsman

Strasbourg, 05/04/2018

 

[1] The device, according to the manufacturer is “a mineral supplement of 100% natural origin that reduces bloating and swelling, balances the digestive system, helping you to find a flat stomach.”

[2] Directive 93/42/EEC concerning medical devices, OJ L 169, 12.7.1993, p. 1. Article 8 reads: “[w]here a Member State ascertains that the devices (...) may compromise the health and/or safety of patients, users or, where applicable, other persons, it shall take all appropriate interim measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service. The Member State shall immediately inform the Commission of any such measures (...)” (2) “The Commission shall enter into consultation with the Parties concerned as soon as possible.).

[3] The process to assess and control elemental impurities in a drug product using the principles of risk management.

[4] The NAMSA report was produced on 17 February 2017. The complainant sent it to the Commission in March 2017 and to the French authorities in August 2017.