To Ministry of Health

Directorate of European and International Health Policy

Department of European Union and Legislative Harmonization

REPORT

Lambros Kotsiris, Proffessor of Aristotle University of Thessaloniki, Associate Professor of National Authority of Medically Assisting Reproduction.

Subject: Participation in the European Committee, Brussels, 9-10 June 2016.

Dear Madams and Sirs

Following the decision 34711/31-5-2016 I attended the Competent Authorities Meeting for tissues and cells of European Commission as a representative of the Ministry of Health on  the 9th  and 10th  of June 2016. Our country was represented by Mr Alexandros Spiridonidis as well, Professor of the University Hospital of Patra, our cooperation was impeccable and highly productive.

The most important issues for our country in my opinion were the following:

  1. Debate on the procedure of harmonization of internal law with the Directives 2015/565 for the Single European Code and 2015/566 for importing cells and tissues. All the above should be incorporated in the Greek law until the 29th October 2016. We notified the European Commission that the Plan of harmonization is ready and the pending issue is the final number of the exemptions allowed and the way they are going to be incorporated via either Law or Presidential Decree. Τhe harmonization plan was the outcome of my cooperation with Mrs Vasia Gioka National Organization of Transplant. As far as the competence of Member States to make exemptions in the application of the Directives, the National Authority suggests to be applied only the excemption of article 10 Directive 2006/86 as was replaced by the article 1 paragraph 3 Directive 2015/565(incorporation in article 37 paragraph 2 PD 26/2008) when the relevant tissues and cells remain in the” same center”. As far as the rest allowed excemptions, it is suggested that they should not be applied and the Documentation Requirements foreseen by the Annexes of Directives to be valid.
  2. The European Commission has asked the undersigned to make the current presentation of the general frame of the Medically Assisted Reproduction in Greece – unknown field for the European Commission and its Members. Consequently my report dated 27 of May 2016 (15 pages) was written in English with the help of special scientists and members of the Authority of Mrs Adamopoulou and Mihalis Pelekanos and was sent on time in the European Commission. It was presented by the undersigned on the 9th of June, issue 2.5 of Agenda and was distributed to all Members. The presentation was met highly positively according my opinion and the Director in charge after thanking for the presentation suggested that experts should be sent at the cost of European Union for promotion and coordination of works, etch concerning MAR.

The most important issue is that our country stopped being absent in the relevant field.

  1. In relation to the European Coding Platform it is recommended to follow a promotion procedure via e-learning.
  2. Issues of Health and establishment of a vigilance system for important-not important expected and not expected diseases and the need to inform as well as the provision for “Vigilence Coordinator” with expertise on diseases separation and hazardship.
  3. There was special report for the transplantation of cornea with recommended action the coordination, the propagation the evaluation the software development the activity description and the structure of a quality data log.
  4. There was a reference to ad hoc answers of Group of Experts on issues of Human Origin. Referring to the tables displayed, it seems that our country has had no participation. The presence to the summit and the intervention of Professor mr Spiridonides quarantee the participation of the country in ad hoc groups of Experts.
  5. In the programme ARTHIQS in relation to information as far as donors of HSC, is concerned Greece has not sent data. Relevant Donor Follow up Guidelines as well as WRS Cord Blood Banking Guide are expected to be issued.
  6. There was reference to cases of infectious diseases like Zika, Flavirius, Ebola etch.
  7. Consequently it would be appropriate for the Authority to make an announcement concerning the dangerous disease called ZIKA and the need to adopt a policy for disease prevention.
  8. The European Committee is to cut down its meetings to three every 2 years. The next meeting is to be on Spring 2017.

Consequently our country was successfully represented and interfered whenever needed. So our country should participate more in Action Programmes and in Subunits of experts and should also collect and send to the European Union facts of interest to the General directorate of Health.

At your disposal for further information.

 

With all my appreciation

Lambros Kotsiris

Professor of Aristotle University of Thessaloniki

Vice President of National Authority of Medically Assisted Reproduction Medicine