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Ares(2017)2866295 - 08/06/2017

EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Directorate B - Health systems, medical products and innovation

B4 – Medical Products: quality, safety, innovation

Competent Authorities on Substances of Human Origin Expert Group

(CASoHO E01718)

Meeting of the Competent Authorities for Blood and Blood Components

1-2 December 2016

Summary Minutes

This meeting of the blood and blood components competent authorities took place on 1 and 2
December 2016. The previous meeting took place on 26 and 27 May 2016.

PARTICIPATION:

Competent Authorities from all Member States (MS) were represented at the meeting. In
addition, competent authorities from Norway, the former Yugoslav Republic of Macedonia,
Montenegro and Turkey, as well as representatives of the Consumer, Heath and Food
Executive Agency (CHAFEA), the European Centre for Disease Prevention and Control
(ECDC), the European Medicines Agency (EMA), the Council of Europe and the World
Health Organisation (WHO) were present as observers.

European Commission/DG SANTE: Mr D. SCHNICHELS (chair), Mr S. VAN DER

SPIEGEL, Ms D. FEHILY, Mr R. MCGEEHAN, Ms I. PUCINSKAITE-KUBIK, Mr P.
CATALANI and Ms A. CORNEA.

1 WELCOME AND INTRODUCTORY REMARKS

The chairman welcomed the participants and thanked the group for a constructive
collaboration on a number of ongoing projects.

2 ADOPTION OF THE AGENDA

The agenda was adopted without any modifications. No conflicts of interest were reported.
3 REGULATORY MATTERS

3.1 Infringement proceedings, parliamentary questions and complaints

The Commission informed participants regarding the results of transposition checks of

Directive 2002/98/EC which are complete for all Member States and have been closed.

The deadline for transposition of Directive 2014/110/EU amending deferral criteria related to
West Nile Virus (WNV) has expired. The infringement proceedings launched against six
Member States for non-notification of transposition have been closed.

The Commission also reported having responded to a number of parliamentary questions such
as on compensation of infected blood recipients, MSM deferral criteria and EU blood self-
sufficiency. The Commission informed the group that complaints in relation to plasma for
manufacturing and labelling requirements for Plasma derived medicinal product are ongoing
and the Commission is analysing the information provided by the Member States concerned.
One of these complaints is also subject to a preliminary ruling case before the European Court
of Justice with the ruling expected in mid-2017

3.2 Transposition of Directive (EU) 2016/1214

Commission Directive (EU) 2016/1214 amending Directive 2005/62/EC as regards quality

system standards and specifications for blood establishments entered into force in August
2016. The transposition period of 18 months expires on 15 February 2018. With this in mind
the Commission asked for an update on progress towards transposition.

One Member State has completed transposition, 11 Member States signalled that they are
advancing the process of drafting the national transposing legislation; some suggested that
they have yet to begin. Besides, 15 Member States highlighted that the transposing legislation
will make a reference to the Council of Europe Blood guide (GPG), 2 Member States plan to
include the translated text of the GPG into the legislation and others have not yet decided.

3.3 Potential amendment of Directive 2004/33/EC as regards temporary deferral

criteria for donors of allogeneic blood donations regarding West Nile Virus

The Commission introduced the request by the European Blood Alliance (EBA) on the
potential amendment of Directive 2004/33/EC as regards deferral criteria on WNV. It was
noted that the topic would be discussed with EBA during the stakeholder meeting of 2
December organised back-to-back with this competent authorities meeting. All participants
had been invited to attend that meeting.

The Commission stressed that the timing for any possible amendment of a Directive is to be
carefully considered in view of the ongoing evaluation of the Blood and Tissues and Cells
legislation.

3.4 Deferral of potential donors with a history of basocellular epithelioma

The Belgian CA gave an update on deferral of potential donors with a history of basocellular
epithelioma. Basocellular epithelioma is the most frequent case of skin cancer.

The question on whether donors with basocellular epithelioma should be excluded from
donation has been discussed. The Belgian CA suggested that these donors should not be
2
excluded based on the low metastatic potential and the lack of documented cases of
transmission. The Belgian CA made a proposal to the group for a working interpretation
which considers basocellular epithelioma as a localized cancer and, based on which,
following complete recovery, such patients would be free to be blood donors (as stipulated in
point 2.1 of Annex III of Commission Directive 2004/33/EC). The working interpretation
proposed was accepted by the group and it was noted that it is for each Member state to
decide on the length of any temporary deferral.

A potential need to consider a change in the legislation in the future was raised by the
participants, in particular with a view to alignment with the tissues and cells legislation.

4 EVALUATION OF THE BLOOD LEGISLATION

The Commission gave an overview of an evaluation of the EU blood and tissues and cells
legislation that was scheduled to start soon. This would be the first formal evaluation under
Commission Better Regulation Package1 since the adoption of the basic Acts in 2002 (blood)
and 2004 (tissues and cells). The objective would be to assess whether the legislation has
achieved its original objectives and is still fit to purpose.

The evaluation includes a number of milestones starting with a roadmap, a study by an

external contractor and consultation of stakeholders. A final evaluation report in the form of a
Commission Staff Working Document is expected to be published by the end of 2018.

The roadmap was scheduled for publication on the Commission's website (published
subsequent to the meeting)2. It is a first step in the evaluation process and outlines the
purpose, content, scope and process of the evaluation.

Competent authorities welcomed the evaluation of the EU legislation and highlighted already
that there are a number of shortcomings in the legislation, in particular on unclear scope,
definitions for some key terms, donor protection and insufficient coherence with other EU
legislation (in particular medicinal products and medical devices).

The Commission services encouraged the competent authorities to provide feedback on the
roadmap and actively participate in the upcoming stakeholder public consultation (Q2 2017),
when approached by the external contractor gathering necessary evidence and in the
stakeholder conferenced to be organised by DG SANTE on 20 September 2017.

5 PRESENTATIONS OF EU-FUNDED ACTIVITIES

EU funded activities were presented and insights given into the VISTART Joint Action and
on two service contracts: Patient Blood Management (PBM) and Education Programme for
Donor Heath Care professionals (DoHeCa). Also, the results of a survey on data collection of
donor test results were presented.

1
http://ec.europa.eu/smart-regulation/guidelines/docs/swd_br_guidelines_en.pdf
2
The roadmap on the evaluation of the EU blood and tissues and cells legislation was published in January 2017.
http://ec.europa.eu/smart-regulation/roadmaps/docs/plan_2016_154_evaluation_eu_legislation_on_blood_en.pdf
The feedback received is published http://ec.europa.eu/dgs/health_food-safety/dgs_consultations/feedback/index_en.htm
3
5.1 VISTART Joint action on blood and tissues and cells

A presentation of the ongoing VISTART Joint Action3 was given by the coordinator of the
project (the Italian National Blood Centre – CNS). The presentation focused on an overview
of the work carried out to date in 10 work packages (WP). Insights and progress made were
given in particular on the WP4 focusing on vigilance reporting for blood, tissues and cells and
WP6 on inspection guidelines.

The Commission welcomed this cross-sectorial Joint Action that addresses a number of
pertinent issues across the SoHO field, such as Serious Adverse Reactions and Events
(SARE) and inspection practices. The authorities were strongly encouraged to provide
comments on the ongoing consultation on the inspection guidelines as well as the draft
deliverables on SARE shared with the participants prior to the meeting. Once finalised the
inspection guidelines will be made available to all competent authorities and will effectively
replace a number of current guidance documents on inspection.

It is notable that blood, tissue and cell experts are increasingly working on vigilance across
these sectors, given the parallel approaches to SARE reporting and rapid alerts. This is
reflected in the work of the VISTART Joint Action and the fact that a number of Member
States vigilance officers work on both sectors.

In this context, the Commission suggested to extend the remit of the existing Haemovigilance
expert sub-group under the CASoHO Expert Group. It was proposed that the existing sub-
group be enlarged to incorporate tissue and cell vigilance experts and merged with the
RATC/RAB expert subgroup to increase efficiency. It was agreed with the participants that a
concrete proposal for the new Vigilance Expert Sub-Group would be shared by the
Commission in early 2017 with a view to (re-)establishing the group. The participants agreed
to the process of planning a new Vigilance Expert Sub-Group.

5.2 Publication of Patient Blood Management guides

Following the presentation at the last competent authority meeting on Patient Blood
Management (PBM) study4 results, the Commission services summarised the comments
received from competent authorities after the meeting, in particular inputs from France and
Germany. The Commission emphasised that the deliverable of the study that was intended to
support authorities in planning for national PBM programmes, does not only address
authorities for SoHO but also for healthcare authorities such as those in charge of hospital
management, patient safety etc. The Commission also explained that another deliverable was
developed to support professionals in hospitals to implement PBM in a practical way.

Further to the comments received, a disclaimer in the final draft will be added to clarify that
PBM should be applied according to national and international clinical transfusion guidelines.

It is expected that the PBM guides would be published early in 2017.

3
The Joint Action VISTART aims to promote and facilitate the harmonisation of inspection, authorisation and vigilance
systems for blood, tissues and cells. The Joint Action consortium includes 20 collaborating and 16 associated partners.
4
The study was conducted by a consortium led by the Austrian Institute of Technology (AIT).
4
5.3 DoHeCa project

An Education Programme for Donor Heath Care professionals (DoHeCa) was presented by
Sanquin on behalf of the consortium partners5.

The DoHeCa project was co-funded by the EU Life Long Learning Programme with the aim
of developing an international Masters curriculum for the education of donation specialists for
blood, organs, tissues and cells. The pilot of the program ran from September 2016 to
December 2017.

5.4 Survey on donor testing data collection by Blood and Tissue Establishments

Sanquin also give a presentation on the project which started with the collaboration of ECDC
and a number of organisations following a discussion on window-period transmissions at a
previous competent authorities meeting. The results of the project were published in the
Journal Blood Transfusion in September 2016.

In summary, the results revealed that a standard selection procedure (SSP) in Member States
is predominant and that pre-donation and donation screening (PDS) is rare. However, given
that seroconversion between the 1st and 2nd donation in SPP group is unknown, PDS could
still be considered for stepwise, careful introduction of new donors.

ECDC commented that the available evidence on the advantages and disadvantages of PDS
was not sufficient to build a position to support the use of this strategy in practice.
Nevertheless, the expert panel recommended that any decision to implement PDS should
follow a thorough cost-benefit analysis and an assessment of possible blood donor losses
performed at the national or regional level.

After the presentations of the above projects, the Commission informed the group regarding a
call for a Joint Action on preparation process authorisation for blood, tissues and cells in the
2016 Work Plan of the Public Health Programme. While the initial proposal co-ordinated by
Italy was evaluated positively, ultimately funding was considered inadequate to achieve the
objectives. To ensure optimal results, the call will be reopened for further nominations and to
allow for an improved proposal. The Commission emphasised that this was an important
opportunity for Member States and clarified that the action will not start before 2018.

The Commission also mentioned that a new Public Health Programme project on Donor
Selection and Protection was awarded to a consortium led by Sanquin.

6 SURVEILLANCE AND VIGILANCE: UPDATE ON INFECTIOUS DISEASES RISKS

6.1 ECDC update (including Zika related issues)

ECDC provided the group with an update of their activities. An overview of epidemiologic
situation worldwide and in the EU was given with an emphasis on Zika related issues.

In 2016, ECDC and a group of experts from the blood, tissues & cells and organs sectors
prepared a document on "Zika Virus and Safety of SoHO"– a guide for Preparedness

5
The consortium includes several European blood and tissue organisations as well as EBA.
5
activities in Europe. This non-legally binding document has an objective to guide the
authorities and SoHO establishments both in Zika virus affected and non-affected areas, on
how to prepare and implement measures to mitigate risk of transmitting Zika through
substances of human origin. ECDC suggested continued adherence in the EU to the universal
screening of blood donations only in Zika-virus-affected areas, as proposed in the guide.

Following a suggestion from a competent authority, a short survey was to be prepared by the
Commission to gather information on the extent the recommendations have been implemented
by the Blood competent authorities and Blood establishments.

It was mentioned that on 18 November 2016 the WHO declared an end to its global health
emergency over the spread of the Zika virus.

6.2 Member State update

France updated on the Zika cases in the French departments of America. Hungary and Italy
also gave an update on autochthonous transmissions of West-Nile Virus and malaria which
took place during the summer.

7 SERIOUS ADVERSE REACTIONS AND EVENTS AND RAPID ALERTS FOR BLOOD

7.1 RAB alerts

The Commission services gave an overview on the RAB launched in 2016. In particular, out
of the 7 alerts 2 were information notices and 5 – epidemiological notices.

The RAB annual summary of activities report has been published at DG SANTE website.6

The Commission also informed the group that following the requests from Member States, IT
improvements to the alert platforms were undertaken by the Commission services. To
increase the effectiveness of the Commission hosted RAB/RATC systems, a new IT version
was deployed in 2016. This includes a number of technical enhancements such as notification
of the closure of an alert to all notified competent authorities.

EDQM introduced a discussion on a recent RAB alert on non-conformity related to a test kit
for Treponema/Syphilis. The EDQM testing proficiency scheme had picked up the issue with
the test kit. A national competent authority in charge of medical devices and in-vitro
diagnostics took the lead in the follow-up. In particular, Ireland and Belgium commented on
coordination activities and risk analysis performed. France presented its approach to obtain
sufficient alternative test kits with the support of the UK authorities.

7.2 Serious Adverse Reactions and Events (SARE)

The Commission highlighted that the 2015 Annual Summary Report on SARE (2014 data)
was published on the DG SANTE website7. The SARE 2016 reporting exercise for the

6
2015 RAB report: http://ec.europa.eu/health/blood_tissues_organs/docs/2015_rab_summary_en.pdf
2016 RAB report has since been also published at:
http://ec.europa.eu/health/sites/health/files/blood_tissues_organs/docs/2016_rab_summary_en.pdf
7
http://ec.europa.eu/health/sites/health/files/blood_tissues_organs/docs/2015_sare_blood_summary_en.pdf

6
subsequent year was launched in June 2016. The Common Approach document
accompanying the reporting exercise had been updated clarifying, in particular, the guidance
on Serious Adverse Event reporting.

Competent authorities were reminded to pass on any communications sent by the Commission
services related to SARE to the relevant contact points in Member States.

The Commission mentioned their plans to contract out work to analyse the SARE data to
Council of Europe (EDQM) and explained that the responsibility in collecting data and
issuing a final report remains within the remit of the Commission.

It was also discussed that a strengthened expert insight into vigilance reporting is important
for improving the implementation of vigilance requirements and data collection.

In this context, the Commission suggested that the first meeting of the newly created
Vigilance expert sub-group (for more details see point 5.1) could take place in the 1st half of
2017. It was also emphasised that that Joint Action VISTART could provide inputs and
recommendations for future consideration on how to improve the vigilance reporting system.

8. UPDATE OF EDQM (COUNCIL OF EUROPE)

An updated on Good Practice Guidelines (GPG) for Blood Establishments and Hospital Blood
Banks was given by EDQM.

A development of Good Practice Guidelines (GPG) is enshrined in Article 2 of Directive

2005/62/EC. GPG, developed jointly by the Commission and Council of Europe (EDQM)
have been published by the Council of Europe, integrated in the 19th edition of the EDQM
Blood guide. Member State participants expressed positive support for the reference to the
GPG in the EU legislation.

The work of the EDQM Committee on Blood Transfusion was also presented and insights on
conventions on Exchange of substances of human origin provided. The Committee activities
involve clarifications of Oviedo convention, in particular on prohibition of financial gain
through donation.

EDQM also gave a presentation on the blood proficiency testing scheme programme (B-PTS)
and blood quality management programme (B-QM) that are run with support from the
European Commission. B-PTS provides blood establishments with an external quality
assessment of their blood donor testing. An insight into key figures and future challenges and
perspectives of the programme was given. Root cause analysis guidance for non-satisfactory
B-PTS results would be published in 2017 and DG SANTE would be asked to disseminate it
to competent authorities. B-QM is an educational programme to support blood establishments
in developing and maintaining comprehensive quality management. EDQM mentioned that
harmonisation of quality management practices in Europe is of utmost importance
considering the endorsement of the GPG into the EU legislation.

7
9 EMA UPDATE

DG SANTE launched, on behalf of EMA, a survey on the Risk Based approach to inspection
on 11 November 2016 via the EUSurvey application8. The objective of this survey was to
identify strategies for inspection and control measures of blood establishments involved in
plasma and blood collection.

At the meeting, EMA gave a preliminary feedback on the survey. The collection of inputs was
ongoing.

10. WHO UPDATE

WHO gave an overview of the document summarising WHO principles on governance of
Medical Products of Human Origin (MPHO). This document has been published at the WHO
website for public consultation, open to individuals and organisations with an interest in
MPHO9.

In particular, the principle on financial neutrality for donors of MPHO was discussed, in
relation to the VUD principle and from the possibility to compensate donors. Some Member
States highlighted the importance that persons who provide their biological material for use in
MPHO should not benefit financially as a result of the donation. The discussion among
Member States made clear, however, that the issue would substantially benefit from a
thorough and broadly accepted definition of terms currently used in an undifferentiated way
in the overall discussion on the principle of prohibition of financial gain made by donation of
the human body and its parts (e.g. financial neutrality, voluntary unpaid donation,
reimbursement, compensation, inconvenience costs). The discussion also pointed out that the
broad interpretation of principles such as financial neutrality or VUD can and need to be
applied differently depending on the different type of SoHO / MPHO e.g. blood, plasma,
tissues, cells, organs, oocytes. Each of these comes with different factors to consider, for
example the fact that blood and plasma donation is different from organ and tissue donation in
its nature and frequency.

WHO clarified that this was a draft version and the objective of the public consultation is to
achieve a global consensus. Following the public consultation, this document was be
presented and discussed among the Member States of the Executive Board in January 2017.

The Commission mentioned that the Charter of Fundamental Rights of the European Union
prohibits making the human body and its parts as such a source of financial gain. It was
considered that the principles outlined in the document were, in general terms, aligned with
the EU legal framework.

11 INTERACTION WITH STAKEHOLDERS

The Commission informed the group that a number of bilateral meetings had taken place
since the previous meeting of the group and presented the key points that have been brought
forward in these meetings with Plasma Protein Therapeutics Association, the International
Plasma Fractionation Association and the European Haematologists Association. To ensure

8
https://ec.europa.eu/eusurvey/runner/BloodEstab
10
http://ec.europa.eu/health/sites/health/files/blood_tissues_organs/docs/2016_call_ls_en.pdf
8
transparency, the Commission has published summary minutes of the meetings on the Public
Health section of the Commission's Europa website. Summary minutes of any further
meetings with stakeholders would also be published on the website.

As discussed in the previous meetings and in the framework of the planned evaluation of
blood, tissues and cells legislation, the Commission services created a forum for discussions
between SoHO stakeholders and the CASoHO Expert Group. In the establishment of this
process, competent authorities were consulted and provided comments on draft Terms of
Reference in September 2016. In October 2016, the Commission services launched a call for
expressions of interest. The list of approved stakeholder organisations interested in
participating in ad-hoc meetings with representative members of the competent authorities on
SoHO expert group was published in November 201610.

On the basis of the agenda, stakeholders would be invited to the meetings that would be
organised immediately before or after the meetings of this expert group. The first ad hoc
stakeholder meeting was to be organised on 2 December 2016. The Commission services
briefly introduced the topics and invited competent authority representatives to actively
participate in the meeting.

12 ANY OTHER BUSINESS

12.1 Regulation of Platelet Rich Fibrin (PRF) - membrane

Denmark raised an issue on Regulation of Platelet Rich Fibrin (PRF)–membrane. It was

highlighted that PRF is one of those that falls on the borderline, being a blood component that
is used for purposes other than transfusion11.

In summary, the collection and testing are covered by the EU blood legislation. However, for
the rest of the process it is less clear which legal requirements apply. This issue has been
raised in the past, also in relation to the preparation of this type of product using bedside
devices. The participants stressed that clarity is needed on the regulatory status of PRF and
that this should be considered in the ongoing evaluation of blood, tissues and cells legislation.

12.2 Change to the legislation on blood donor eligibility/MSM deferral

France presented a change to the legislation on blood donor eligibility for men who have had
sex with men (MSM) deferral and the rationale behind it. Other participants were invited to
report on their national plans/updates regarding MSM in future meetings.

12.3 Transatlantic Trade and Investment Partnership (TTIP) and blood, blood
components and blood products

TTIP negotiations were currently ongoing at political level with no particular developments
for the blood sector at the time.

12.4 Correction of information on Italy in the published Implementation Report

10
http://ec.europa.eu/health/sites/health/files/blood_tissues_organs/docs/2016_call_ls_en.pdf
11
Cf. the exclusion from Directive 2002/98/EC, Article 2.1
9
Italy asked for a correction to information in an implementation report published by the
Commission in May 2016.12

Specifically, the report noted that Italy discards surplus plasma whereas the Italian authorities
clarified that only surplus red blood cells are discarded. It was underlined that Italy
fractionates any plasma that is not transfused.

It was agreed that the Commission will not launch the erratum corrigendum procedure which
is linked to a considerable administrative burden, but the recording of Italy's corrective
statement in these meeting minutes will be sufficient to correct the record.

13 FINAL REMARKS

The next meeting of the blood NCAs is scheduled for 22-23 June 2017.

12
SWD, p. 35, http://ec.europa.eu/health/sites/health/files/blood_tissues_organs/docs/swd_2016_129_en.pdf
10