CELLS LEGISLATION STAKEHOLDER EVENT September 20th 2017 1 Health - - PowerPoint PPT Presentation

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EVALUATION OF THE BLOOD, TISSUES AND CELLS LEGISLATION STAKEHOLDER EVENT September 20th 2017

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Comment via Twitter from today for 7 days

• #BloodTissuesCellsEU

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• Martin Seychell
• Deputy Director General
• DG-Santé, European Commission
• Anna-Eva Ampélas
• Head of Unit
• DG-Santé, European Commission
• Medical Products: Quality, Safety and Innovation

SESSION 1: WELCOME AND INTRODUCTION

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Substances of Human Origin

ORGANS Out of scope

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Red blood cells

Plasma

EU Blood sector

Platelets

For Transfusion

Key facts

• 14 million citizens donate 20 million whole blood units per year
• Allowing for 26 million transfusions per year (RBC >> platelets, plasma)
• 1350 authorized blood establishments in the EU (+1200 mobile/satellites)
• Needed for surgery, trauma, oncology, …

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Manufacturing/Fractionation

Medicinal nal Products ducts ( C Clotting ng factor tors, , album umin, n, immunogl noglobul

• bulins

ns etc. )

Plasma

EU blood sector

For manufacturing

Key facts

• About 8 million liter of EU-collected plasma manufactured by public and

private fractionators

• Global exchange of collected plasma and plasma derivatives
• Indications: immunodeficiencies, haemophilia, clotting disorders, …

=

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EU Tissues and cells sector

T&C types

• Bone
• Ocular tissue
• Skin
• Cardiovascular

tissues

• …

Replacement Tissues and cells

Indications Orthopedic surgery Blindness Burn wounds Heart insufficiency Starting materials for innovative therapies

Key facts

• 1357 authorized tissue establishments in the EU
• > 300,000 units distributed for transplantation per year
• Often local collection for local supply, but also regional exchange

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EU Tissues and cells sector

Haematopoietic Stem Cells

Indications Blood cancers Starting materials for innovative therapies T&C types

• Bone marrow
• Peripheral blood

stem cells

• Umbilical cord

stem cells

Key facts

• 1047 authorized tissue establishments in the EU
• > 30,000 units distributed for transplantation per year
• Global exchange network to match donors and recipients at best

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EU Tissues and cells sector

Reproductive Cells and Tissues

Indications Fertility treatments Fertility conservation T&C types

• Oocytes
• Sperm
• (gametes)
• Embryos
• Ovarian tissue
• Testicular tissue

Key facts

• 1723 IVF clinics authorized as tissue establishments in the EU
• > 500,000 units distributed for clinical application per year
• Mainly organised locally, with international flows of gametes (and couples)

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Art .168 (4)

"The European Parliament and the Council … shall … adopt: (a): measures setting high standards of quality and safety of

• rgans,

and substances

• f

human

• rigin,

blood and blood derivatives; these measures shall not prevent any Member State from maintaining or introducing more stringent protective measures.

• Art. 168 (7)

… These measures (para 4(a)) shall not affect national provisions on the donation or medical use of organs and blood."

• Mandate for quality and safety standards at EU-level
• Member

States may complement these with national measures

• Member States decide what can be donated and used

EU Legal Basis

• Art. 168

/Mandate

TFEU

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• 1. Basic Acts (Council and EP)

Main Provisions:

• Designation of Competent Authorities
• Authorisation and Inspection
• Traceability and alert systems
• Quality Management and responsible persons
• Principle of voluntary and unpaid donation
• Consent and data protection
• 2. Technical Directives (Commission)
• 3. Soft Law Tools (Commission+Experts)

Directive 2004/23/EC 4 Directives implementing technical requirements Rapid Alert System T&C Guidelines on inspections

EU Legal Acts

Directive 2002/98/EC 4 Directives implementing technical requirements Rapid Alert System Blood Guidelines on Q systems Blood and blood components Tissues and Cells

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Collect/ Procure Test

Distribute

Professionals National Competent Authorities European Commission

Oversight: autorisation, inspection, vigilance, traceability,… EU-level support: rapid alerts, coding system… 1 2 3

Store Human application Process Donation

EU requirements

Procure- ment Process

• ing

Distribu- tion

Preser- vation/ Storage Dona- tion Testing

Selection/deferral, consent… HIV, Hepatitis B, Hepatitis C.. Quality requirements

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• The purpose of the evaluation is to provide a comprehensive

assessment of the directives, examining their functioning across the EU.

• In particular the evaluation will assess the extent to which the

Main Directives have met their original objectives and whether they remain fit for purpose assessing also the contribution of the Implementing Directives.

• The evaluation is expected to provide a sound evidence

base which will be used to consider the need for any changes to the legislation.

Purpose The Evaluation

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• 1. Relevance
• 2. Effectiveness
• 3. Efficiency
• 4. Coherence
• 5. EU Added Value
• Still up to date? (science,

technology, epidemiology, commercialisation, new actors)?

• Increasing safety and quality?

Negative side-effects or barriers?

• Benefits and costs for

establishments, clinicians, authorities?

• Consistent with other legislation,

any gaps and overlaps?

• Could the results be achieved

better at national or global level?

Assessment Criteria

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• 1. Evidence from monitoring
• 2. Previous implementation reports
• 3. Issues arising from implementation (complaints,

infringement procedures, interpretation/scope questions)

• 4. Consultation
• Open public - for citizens (online)
• Targeted public - for organisations (online)
• Meetings for stakeholder organisations
• This public event
• 5. External contract - review of evidence and filling
• f gaps (ICF Consulting)

Evidence Base

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163 responses from organisations 43 responses from individual citizens

• All responses will be published online (where

consent allows)

• A summary report will be published online by the

Commission

• Preliminary summary at the end of the

programme today (by ICF)

Stakeholder responses

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• Contractor – ICF Consulting
• Support Commission in evaluating legislations
• Supported by 3 experts: Imogen Swann,

Margarethe Heiden, and Sinead Masterson

• Contractor to
• focus on examining evaluation questions
• independently document an evidence base, i.e. an

independent study by mid 2018

• Commission to bring together the work of the

contractor, EC services and results of the public consultation in Commission Staff Working Document by end 2018

External Study

European Commission

Commission Staff Working Document

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Key elements Estimated timing

Roadmap consultation Q1 2017 Public consultation Q3 2017 External contract Q2 2017 – Q3 2018 Commission evaluation report Q4 2018

Timeline

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• MODERATOR:

Arlette Delbosc Ministry of Health, France

• Discussion on donors and their protection, addressing topics such

as voluntary unpaid donation, compensation, donor safety and follow up, donor recruitment and donor registries.

SESSION 2: The key importance of donors – The gift of life

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International Federation of Blood Donor Organizations (FIODS)

• Alice Simonetti

The key importance of donors: the IFBDO point of view

• ETHICS

The principle of voluntary AND unpaid donation (VUD) needs to be further stressed and specified, as it represents one of the main guarantees for the safety and quality standards for blood and blood components, as outlined in the legislation under review, and for donors’ and patients’ protection.

• COOPERATION

We stress the need for a wider recognition of voluntary organizations in the field of blood and plasma donation, their role in the transfusion system in cooperation with EU & national health institutions, and their work for donors’ recruitment and retention.

• UNIFORMITY AND GUIDELINES

We recognize the necessity to set basic and common standards for blood and blood components collection in order to ensure the donors’ and recipients’ safety.

• ORGANISATION AND SHARED RESPONSIBILITY

The EU should encourage/request member countries to set up plans on how to secure self-sufficiency in plasma and PDMP from voluntary and unpaid donations, as already emphasized by the Council of Europe.

20 September 2017 – BRUSSELS, Centre de Conférence A. Borschette Alice Simonetti, International Federation of Blood Donor Organizations (FIODS)

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International Haemovigilance Network (IHN)

• Arlinke Bokhorst

The directives should regulate the protection of donors from physical and mental harm resulting from donating SoHO

• It should be mandatory to collect and analyse SARE happening to donors
• Collection centers should assess events and take mitigating actions to

reduce the risk for donors

• Evidence based donor selection criteria should safeguard the safety of

donors during and after donation procedures

• Donors have to be informed of the potential risk of donation procedures
• Donors should be able to receive independent counseling on risks
• The acceptability of certain risks for donors should be in balance with

the beneficial effects for the recipient and assessed by independent experts

• Donor vigilance data should be reported on a national/European level in
• rder to inform the public about risks, recommend preventive measures

and monitor trends

Protecting donors supports willingness to donate and therefore indirectly contributes to patient care

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European Society for Human Reproduction and Embryology (ESHRE)

• Carlos Calhaz Jorge

ART

Specificities Risks for donors Safety of donors Risks for recipients

• Partner vs Non-partner donation
• Definition of partner donation
• Clinical application depends of

MS legislation

• To limit the number of oocyte

donations

• To define strict rules on

economical compensations

• To improve traceability in cross-

border ART

The key importance of donors – The gift of life

• OHSS
• Oocyte retrieval complications
• Psychological implications
• Traceability
• Multiple pregnancies
• Outcome registries

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World Marrow Donor Association (WMDA)

• Lydia Foeken

Quality & Safety are Key: All our global members adhere to EU standards, ensuring the quality and safety of the stem cell products we disseminate worldwide. Exemplary track record: 21,881 cellular products were provided coming from volunteer donors and only 6 severe incidents related to donation were reported in 2016. Power of NGOs to set standards: avoids country specific approaches. Need focus on quality and safety standards: less administrative burden! Evolving society and science: future proof, don’t inhibit.

https://www.wmda.info

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• MODERATOR:

Ian Rees, Medicine and Healthcare Products Regulatory Agency (MHRA), UK

• Discussion
• n

the impact and cost

• f
• rganising

regulatory

• versight, addressing topics such as inspection, authorisation,

vigilance and traceability.

SESSION 3: Regulatory oversight of the sectors

• How to ensure safety and quality

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European Association of Tissue Banks (EATB)

• Simone Hennerbichler

Key messages – regulatory

• versight

Inspection/ authorization  harmonization/ mutual recognition of national requirements, practices and authorization  adoption of the EDQM T+C Guide as technical standard of EUTCD Vigilance/ traceability  coherence of contents and legal requirements within corresponding/overlapping directives (e.g. T+C with organs)

20.09.2017 EC stakeholder meeting Brussels

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National Transplant Centre Italy (CNT)

• Alessandro Nanni Costa

September 20th 2017, Brussels Alessandro Nanni Costa Italian National Transplant Centre

What is not adequately covered in the current legislation?

Donor and patient followup; Activities presently not covered: autologous transplant during surgery - e.g. adipose tissue, microbiota; Ad-hoc procedures for authorising new/experimental processes (work of VISTART and GAPP JA); Commercialisation issues

How to ensure safety and quality? inputs for discussion

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Paul Ehrlich Institute (PEI) Germany

• Dorothea Stahl

• D. Stahl, W. Kammer / 20.09.2017

Regulatory oversight - How to ensure safety and quality?

Inspection, authorisation, vigilance, traceability: Factors to take into account in the field of transfusion medicine

Scenario 1: Novel preparation methods, novel products Access to clinical data

• Clinical data are required to evaluate product quality, safety,

and functionality / efficacy

• Registries to achieve access to clinical data

Regulatory oversight requires a data-based framework

• Explore possibilities to support digitized structures of data

exchange and data analysis

Scenario 2: Emergency preparedness Coordination of regulatory oversight in crisis situations in the European setting

• Cross-organizational preparedness plans to strengthen structures for blood supply in crisis situations
• Divergency of product release criteria

Scenario 3: Safety and quality of medical devices / IVD related to blood component manufacturing, testing Coordination of regulatory oversight at the interface of medical devices / IVD and blood components

• Acceptance criteria for medical devices / IVD used in transfusion medicine

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Vigilance Expert Sub-group to the Commission's Expert Group

• n Substances of Human Origin

(EU Competent Authorities)

• Jo Wiersum

Serious adverse reaction and event (SARE) reporting

Vigilance aims

TRUST: Donors Healthcare professionals Regulator The public

– Whole chain – All organisations participate – Valid data – Analyses (trends, causes) – Results made public

• Regulatory oversight
• Transparency
• Quality & Safety improvement

(via multiple routes) Include donor SARE & clinical SAE Strengthen hospital vigilance Improve definitions+guidance

Root cause analysis, recommendations

Improve visibility

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• MODERATOR:

Beatriz Dominquez-Gil National Transplant Organisation (ONT), Spain

Discussion on the challenges to ensuring adequate availability and sufficiency of blood, tissues and cells for patients, addressing topics such as access, matching supply and demand, cross-border exchanges.

SESSION 4: Availability and sufficiency - Are patients getting the blood, tissues and cells that they need?

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Platform of Plasma Protein Users (PLUS)

• Johann Prevot

PLUS position on blood legislation & policy

• Blood policy should be equally patient- and donor-centred
• Scope of legislation:

– Should cover quality, safety and supply – Differentiation of blood and plasma needed

• Concepts to be introduced:

– Availability & continuity of supply of blood components & PDMPs – Promotion of increased plasma collection – Implementation of GMPs and testing requirements EMA PMF – Plasmapheresis programmes where feasible – Avoidance of wastage of plasma – Definitions

• Access – how can we promote wide access to EU patients?

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International Plasma Fractionation Association (IPFA)

• Paul Strengers

IPFA key message

EC Stakeholder Event for the Evaluation of the EU Blood, Tissues and Cells Legislation 20 September 2017

• Clinical use of PDMPs is growing globally – particularly for immunoglobulin products

(6,5% per annum in Europe)

• EU patients are increasingly reliant on PDMPs manufactured from US collected plasma for fractionation (64%
• f global plasma supply is from the US)
• This dependency represents a risk in case of new outbreaks of TTIs that cannot be inactivated/ removed e.g.

vCJD in the UK

• We therefore need to strengthen EU supply. EU legislation can do so by advocating and enforcing a degree of

´strategic plasma independence´

• Strategic independence implies an appropriate balance between domestic supply and importation
• IPFA is committed to VUD for plasma as well as for blood

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European Society for Blood and Marrow Transplantation (EBMT)

• Christian Chabannon

www.ebmt.org #EBMT18

Availability and sufficiency - Are patients getting the blood, tissues and cells that they need? The case for Hematopoietic cell transplant and cellular therapies

475.000 US$

Cell transplant engineered by tissue establishments vs somatic cell therapy medicinal products and gene therapy medicinal products manufactured from autologous or allogeneic hematopoietic cells Related donors vs unrelated donors: related donors for all? Variable likelihood of identifying an unrelated donor, depending on patient origin? Consequences of technical sophistication of modern HLA-typing?

• Personalized medicine

Voluntary unpaid donation (allogeneic HCXT, “off-the-shelf” cellular therapies? Long-term follow-up. Reporting. Registries Financial toxicity

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European Eye Banking Association (EEBA)

• John Armitage

European Eye Bank Association

• Meeting demand – corneal transplants per million

population

– USA 200 pmp – demonstrates potential of procurement to meet demand – EU Member States 8 to 90 pmp (15 MS <50 pmp)

• Limitations

– Availability of corneas

• Organization of eye banks and procurement – national, regional, local

– Availability of medical and nursing staff – Theatre time – Defining tissues and cells as medicinal products

• Concerns

– Procured ethically (voluntary unpaid donation) – Quality and safety (Council of Europe T&C Guide)

• Consistent SARE reporting and investigation across MS
• Clinical outcome – European Cornea and Cell Transplant Registry (ECCTR)

– Cross border transfers: undermining of self-sufficiency

• Tissue for research and training

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• MODERATOR:

Michael Cox Danish Patient Safety Authority

Discussion to address consistency and coherence with other relevant Union legislation and with equivalent legislation internationally.

SESSION 5: Legal consistency and coherence

• Regulatory pathways for

Substances of Human Origin

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Plasma Protein Therapeutics Association (PPTA)

• Jan Bult

www.pptaglobal.org 20 September 2017

Jan M. Bult President and CEO

• COMMON GOAL FOR ALL EU LEGISLATION AFFECTING THE PLASMA SECTOR IS TO PROTECT HUMAN HEALTH

‒ “The essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health” (recital 2 of Directive 2001/83/EC) ‒ Goal of the Blood Directive is to “ensure a high level of human health protection” (art 1 of Directive 2002/98/EC) ‒ “ A high level of human health protection shall be ensured in the definition and implementation of all the Union’s policies and activities ” (Art. 35 of the EU Charter of Fundamental Rights)

• THIS INVOLVES THE (NON-NEGOTIABLE) DUTY TO PROTECT PATIENTS: EUROPEAN PATIENTS NEED PLASMA PRODUCTS
• WHAT ARE THE CURRENT ISSUES?

‒ No clear demarcation between the Blood Directive and Directive 2001/83/EC ‒ No clear recognition of the specificities of plasma in EU legislation ‒ No definitions of key concepts, such as VUD/compensation and self-sufficiency ‒ Need to modernize

• THIS IS CAUSING:
• Legal uncertainty demonstrated by several legal cases brought before the ECJ
• Internal Market fragmentation:

‒ Excessive national deviations from the Internal Market principles: remove national barriers ‒ Inconsistent (and often inadequate) interpretations of some key concepts: remove patchwork

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Common Representation of SoHO Associations (CoRe SoHO)

• Esteve Trias

Organs T&C Blood Medical Devices ATMP Lack of coherence of the legal contents and requirements (donor selection / Voluntary Unpaid donation/ Testing/ Vigilance) Lack of harmonization amongst ME (HE, Testing, pooling, circulation, classification, etc.) National Regulations Communicable Diseases

Need for continuous technical Updated

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Cell and Gene Therapy Catapult Alliance for Regenerative Medicine (ARM)

• Jacqueline Barry

Evaluation of the Blood, Tissues and Cells Legislation Legal consistency and coherence - Regulatory pathways for Substances of Human Origin - Focus on ATMP

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Case Study US company plans to conduct Phase II trial on ATMP in a number of EU MS. Manufacture takes place in US Problems encountered

• Lack of harmonisation of cell, tissue and blood requirements across the EU
• Classification – Blood, T&C or Medicine?
• Donation Testing
• GTP standards
• Interface with Medicines Legislation and ATMP Regulation 1394/2007
• Storage of donor material for use as a starting material
• Testing – suitability of testing for use as a starting material, different testing requirements
• Labelling requirements
• Near patient processing
• Tissue Establishment and Designated individual availability
• Import/export requirements
• Inspection/accreditation as Tissue Establishment vs Pharmaceutical Establishment
• Responsible person - DI or QP ?
• International
• Lack of acceptance of minimum standards in other territories

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American Association of Tissue Banks (AATB)

• Frank Wilton

Frank Wilton, President and CEO American Association of Tissue Banks

• Approximately 600,000 grafts sent

to EU from AATB accredited tissue banks in 2016

• 3 Key Recommendations:
• Maintain alignment, compatibility

and clarity across Directives/Regulations

• Clarify the SEC
• Exclude HCT/Ps from VAT

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• MODERATOR:

Mona Hansson Health and Social Care Inspectorate, Sweden

• Discussion on topics such as changing risks, changes in society,

bio-technological innovation, globalisation and commercialisation.

SESSION 6: A changing world – Technological, societal, epidemiological and international developments

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European Centre for Disease Prevention and Control (ECDC)

• Dragoslav Domanovic

INFECTIOUS DISEASES AND THE SAFETY OF BLOOD, CELLS AND TISSUES

Dragoslav Domanović, ECDC, Stockholm Sweden

• Increasing frequency of infectious diseases outbreaks -

threat to the safety of blood, cells and tissues

• ECDC response to the infectious threats to maintain the

safety of blood, cells and tissues

• Preparedness activities - timely response to threats
• Collaboration EU Commission - ECDC - NCAs - SoHO

establishments in response to threats

• EU legislation/regulations and ECDC recommendations
• f SoHO safety

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Expert on Blood of the Ministry of Health, Romania

• Alina Mirella Dobrota

• EU new legal frame needs a degree of flexibility to ensure its feasibility for all

28 MSs, to come up to a certain Communitarian safety level despite differences in GDP/capita

• Epidemiological regional specificities and new emerging viruses, continuously

challenge CAs to identify proper solutions both to stay within the EU regulatory provisions and to maintain national blood supply and transfusion safety

• Up to what extent should QM be implemented as a mandatory provision to

ensure an acceptable quality and safety level of transfusion activity?

• Strengthening cooperation between MSs would facilitate proper

implementation of EU Directives in newer MSs and candidate countries

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European Society for Human Reproduction and Embryology (ESHRE)

• Kersti Lundin

Society Technology /Safety Globalisation Commercialisation

• New ways of family building – gender/transgender issues - lack of

harmonisation and often inadequate regulation

• Third party donation – the genome on-line (genetic ancestry testing)
• Genetic screening – patients, embryos – how to handle
• Epigenetic changes – how flexible are we?
• Germline genome editing, artificial gametes….
• Different regulations in MS  crossborder care (good/bad)
• Donors/gametes on the internet – lack of control
• Novel (non-tested and/or non-evidence based and/or non-

efficient) techniques and therapies, pushed by companies (and by patients)

A changing world - ART

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European Blood Alliance (EBA)

• Philippe Vandekerckhove

A changing world

Societies change and medical sciences advance but source of blood remains unique

Changes in society and technology

• Synthetic and biotech blood remain expensive niche products - Blood products remain

unique and needed – equal access to this limited strategic resource should be secured

• Aging & Migration - new requirements for donors and patients in new generations and

cultures;

• New and re-emerging EIDs – adaptive and risk-based decision making based on scientific

evidence

• ECJ case law is driving blood towards a consumer market regulations - A substance
• btained from a human donor cannot be treated as a commodity, as intended in the EU

Blood Directive EU should choose direction

• Donor safety is of paramount importance to the sustainable supply of blood products –

VNRD is a cornerstone

• Emphasizing the no-financial-gain-principle and blood as a health service
• Harmonising inspections by different Competent Authorities to create a level playing field

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• Rapporteur summary and highlights from

the Online Consultation

• ICF Consulting Ltd.
• Closing Remarks: Andrzej Rys
• Director, Directorate B, DG-Santé, European Commission

SESSION 7: Conclusions and closing remarks

20/09/201 7 Prepared for DG SANTE Eliana Biundo

Preliminary summary of

• nline public consultation
• n the Evaluation of the EU

blood and tissues and cells legislation

ICF proprietary and confidential. Do not copy, distribute, or disclose. ICF proprietary and confidential. Do not copy, distribute, or disclose.

Open Public Consultation (OPC)

20/09/2017

The aim of the consultation was to gather:

• views and opinions on the implementation of the blood, tissues and cells legislation;
• factual information on what works well and where there is still room for improvement;

and

• data and knowledge about the impact of the legislation.

43 citizens submitted inputs 163

• rganisations

submitted inputs

Findings in this presentation are preliminary and based on submissions received by 1 September (127 organisations and 35 citizens) The consultation closed on 14 September (163 organisations and 43 citizens). A full synopsis of the inputs to the OPC will be published in the coming months.

Submission s from 20

MSs

• Public administration within the EU
• Blood/Tissue Establishment
• Donor recruitment and

procurement/collection

• Patients
• Donors
• Healthcare provision
• Manufacturers of downstream

products using blood, tissues or cells as a starting material

• Equipment or service provision
• Academic or scientific

research/development

• Public administration outside the

EU

ICF proprietary and confidential. Do not copy, distribute, or disclose. ICF proprietary and confidential. Do not copy, distribute, or disclose.

• The legislation is not adaptable enough to manage risks and

changes, such as:

• technological/ scientific
• epidemiological (WNV, Malaria, Zika, etc.)
• societal e.g. ageing, migration, same-sex couples
• …
• In particular, it is lacking in:
• procedures to keep legislation up to date
• provisions for the authorisation of novel/experimental treatments
• clarity of scope (new SoHO, stakeholders, activities)
• provisions addressing specificities of subsectors (plasma, ART,

etc)

• involvement of experts (EDQM, ECDC, professional societies, etc.)
• …

PRELIMINARY FINDINGS BY EVALUATION CRITERIA

20/09/2017

Relevance

ICF proprietary and confidential. Do not copy, distribute, or disclose. ICF proprietary and confidential. Do not copy, distribute, or disclose.

• The legislation has helped increase safety and quality (Blood – 90%;

Tissues and Cells – 99%)

• But several provisions are not adequate or missing:
• Donor safety (donor reactions and donor follow-up, including long term)
• Clinical outcomes (post transplant/transfusion/ART)
• Impact on supply/sufficiency (plasma, corneas)
• Voluntary Unpaid Donation (VUD) – unclear and varying interpretation
• Unclear Vigilance definitions and requirements
• …

PRELIMINARY FINDINGS BY EVALUATION CRITERIA

20/09/2017

Effectiveness

ICF proprietary and confidential. Do not copy, distribute, or disclose. ICF proprietary and confidential. Do not copy, distribute, or disclose.

• The legislation led to higher costs but it also brought benefits that

justified the costs (Blood - 80%, Tissues and Cells - 88%)

• Specific cost issues raised in relation to:
• smaller blood and tissue establishments that face higher costs
• GMP and air quality requirements [Tissues and Cells]
• Burdensome oversight rules (e.g., inspection planning/frequency)
• Insufficient attention is given to:
• assessing cost effectiveness of safety measures [Blood]
• re-evaluating technical criteria to ensure balance between safety

and costs (e.g. testing, donor selection)

• …

PRELIMINARY FINDINGS BY EVALUATION CRITERIA

20/09/2017

Efficiency

ICF proprietary and confidential. Do not copy, distribute, or disclose. ICF proprietary and confidential. Do not copy, distribute, or disclose.

• The legislation within its own provisions is generally coherent.
• But inconsistencies for certain sectors highlighted (regulation of donor, e.g.

lymphocytes)

• Incoherencies with other relevant EU legislation highlighted and issues

raised:

• Borderline definitions (Medical Device, Medicinal Products

legislations/ATMP/PlasmaDMP)

• Some SoHO fall under different legislations across Member States
• Communication between the sectors not optimal (e.g., for vigilance)
• No harmonisation of inspection requirements under different legislations
• Link to legislation on communicable diseases and role of ECDC
• EU charter of human rights and commercialisation (VUD and non-profit)
• …

PRELIMINARY FINDINGS BY EVALUATION CRITERIA

20/09/2017

Coherence

ICF proprietary and confidential. Do not copy, distribute, or disclose. ICF proprietary and confidential. Do not copy, distribute, or disclose.

• The legislation has helped increase safety and quality,

harmonisation and confidence

• Blood - 74% and Tissues and Cells - 64% of organisations believe

that:

• this could not have been achieved at national level, or
• might have happened but EU legislation sped up the process
• 80% of citizens believe that the same results could not have been

achieved without EU action.

• …

PRELIMINARY FINDINGS BY EVALUATION CRITERIA

20/09/2017

EU Added Value

Thank you!

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Closing Remarks

Andrzej Rys

https://ec.europa.eu/heal th/blood_tissues_organs/ policy/evaluation_en Follow the Evaluation process here!

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