matériaux médicaux implantables : le point aujourd’hui par vanessa binamé | liege creative,...
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Parole d’expert
Christian GRANDFILS, ULg-CEIB, Vanessa BINAME, DG Post | AFMPS, Françoise SCHLEMMER, Quasys Consult, Henri DECLOUX, MEDI-LINE
Matériaux médicaux implantables : le point aujourd’hui
Avec le soutien de :
Federal agency for medicines and health products
Medical devices – New Belgian Landscape Plan of our Public Health Minister
Vanessa Binamé
Subject famhp/entity/Division-Unit-Cell
Date 2
Legal context
§ The law establishing the creation and the functioning of the Federal Agency for Medicines and Health Products of July 20 2006 (B.O.J. 08.09.2006)
§ The Law on the medicinal products of 25.03.1964 (B.O.J.
17.04.1964) - revised dd. 01.05.2006 (B.O.J. 16.05.2006) and its implementing decrees
The FAMHP is a public interest organization with juridical personality, classified in category A referred in the law of March 16 1954 relating to the control of certain public interest organizations
FAMHP - Presentation
Subject famhp/entity/Division-Unit-Cell
Date 3
“Ensuring, from development to use, the quality, safety and efficacy:
§ of medicines for human and veterinary use, including homeopathic medicines and herbal medicines, pharmacy made and officinal preparations;
§ of health products including medical devices and accessories, and raw materials (active pharmaceutical ingredients) for the preparation and production of medicines.
Ensuring, from collection to use, the quality, safety and
efficacy: § of all operations involving blood, cells and tissues,
which are also defined as health products”.* * Based on the law of 20 July 2006 (B.S. - M.B. 08/09/2006) concerning the
establishment and functioning of the FAMHP.
Mission
Subject famhp/entity/Division-Unit-Cell
Date 4
‘Stakeholders’ or partners
Policy makers (Member States)
Policy makers (UE institutions
University and Research Centers
Competent authorities
(Administrations)
Healthcare professionals
Industry
Patients
Subject famhp/entity/Division-Unit-Cell
Date 5
Organisation chart
Subject famhp/entity/Division-Unit-Cell
Date 6
Medical devices
New Belgian Landscape
Plan of our Public Health Minister
Subject famhp/entity/Division-Unit-Cell
Date 7
Why a plan?
Medical Devices • Essential for the health sector • Source of innovation • Improve the quality of life
Ø Better traceability, evaluation and control will increase the quality and safety of medical devices
Ø A clear legal framework with direct sanctions will eliminate the crooks, smugglers and the ignorants
Ø ⇒ A scandal like the PIP should never happend again!
Subject famhp/entity/Division-Unit-Cell
Date 8
Structure of the plan
8 strategic axes
Subject famhp/entity/Division-Unit-Cell
Date 9
Traceability
Objectives • Full traceability from the manufacturer to the
patient for each medical device implanted
• Able to know at every moment where a specific device is
• Opportunity for the patient to consult which medical device was implanted to him
Subject famhp/entity/Division-Unit-Cell
Date 10
Traceability
" Better knowledge of what is on the Belgian market " Better knowledge of what is in the patient " Better information of the patient " Better capacity of control
⇒ Short time and specific reaction in case of incident
Subject famhp/entity/Division-Unit-Cell
Date 11
Traceability - Representation
Manufacturer Intermediate Distributors
Distributors
Pharmacy (Hospital / Retail)
Patient
Distribution / Implantation
Information exchange
Central Registration
Health Professionals
Data on request
Subject famhp/entity/Division-Unit-Cell
Date 12
Traceability
• Participation of all the actors concerned
• Simple, friendly, should not be an additional burden for § Industry § Health professionals § Authorities
⇒ Focus on the essential
Subject famhp/entity/Division-Unit-Cell
Date 13
Traceability
Identification of Ø Implantable medical devices (authentic source / famhp)
Ø Distributors of implantable medical devices (authentic source / famhp)
Ø Pharmacies (authentic source / FPS Public Health, INAMI, famhp)
Ø Health professionals (authentic source / FPS Public Health)
Ø Patients (entirely coded)
Subject famhp/entity/Division-Unit-Cell
Date 14
Traceability
Registration Ø Data on implantable of medical devices
Ø Movements from the final distributor to the patient
Subject famhp/entity/Division-Unit-Cell
Date 15
Traceability
New rules
• Implantable on « pres/post »cription (document from a doctor for a specific patient)
• Distribution via pharmacy ⇒ strenghtening of the role of the pharmacist
• Notification of the use of an implant
• use of implantable medical devices only if already registred in the traceability system
Subject famhp/entity/Division-Unit-Cell
Date 16
Traceability
• Integration in eHealth plateform
• Data exchange from system to system
• Generation of a patient’s information carte
• Use international standardisation and national conversion tables when really needed
• Exchange data with Eudamed II / III
• Respectful for the private life of implanted patients
Subject famhp/entity/Division-Unit-Cell
Date 17
How can regulators, industry and health care providers work together on this
• Should be a win/win situation for everyone
• Communication – Concertation - Step by step approach
• Development of interfaces system to system
• Let all the doors open and pay attention to the SMEs
• Take into account the advanced states of technological development (eg UDI, Combined Products, Combination Packages,…)
Subject famhp/entity/Division-Unit-Cell
Date 18
Control
Distributors • Each belgian distributor will be inspected once every 5
years • Start with the distributors of implants
Thematic controls • Control focused on specific points (materiovigilance
conformity, notification obligation, europeese issue, border line products,…)
• Re-Testing on medical devices (risk based analysis, cost, availabilities of laboratory)
Subject famhp/entity/Division-Unit-Cell
Date 19
Control
Publicity and information to patient (or health professional)
• Clear rules for medical devices advertisement and
information
• Methodology of control for publicity and information
Subject famhp/entity/Division-Unit-Cell
Date 20
Control
• Fraud
" false CE mark, " medical devices on our market without CE mark
• Clinical trials
" GCP, " notification to the afmps, " Deviation from the protocol
Subject famhp/entity/Division-Unit-Cell
Date 21
Control
• Efficiency of control
" Check list " Standardisation and simplification of the report " Administrative support " Progressive and continue training of inspectors
in the medical devices area " Autocontrol
Subject famhp/entity/Division-Unit-Cell
Date 22
Control
• Information of all the actors
• Rapid and direct sanctions
Subject famhp/entity/Division-Unit-Cell
Date 23
Control
Redevance
" Every distributors has to participate to the regulation of the medical device landscape
" Benefit for everyone: the patient and the sector
Subject famhp/entity/Division-Unit-Cell
Date 24
Evaluation
• Enlargement of the expertise inside famhp
• Better view on clinical trial
• Link with materiovigilance and FU of clinical trials
• Collaboration with ethic committees
• Check of the capacity for clinical evaluation for the notified bodies and peer review for high risk MD
Subject famhp/entity/Division-Unit-Cell
Date 25
In the recast chapter VIII: • Establishment of an expert committee
(Medical Device Coordination Group - MDCG)
• Members appointed by the Member States
Benefice risk evaluation >< safety and performance?
Evaluation - European Expert Group
Subject famhp/entity/Division-Unit-Cell
Date 26
Tasks MDCG 1. Contribution to the assessment of notified bodies 2. Contribution to the assessment of higher risk
medical devices 3. Development of guidance 4. Coordination in the fields of clinical investigations,
vigilance and market surveillance 5. To provide advices to the Commission
Evaluation - European Expert Group
Subject famhp/entity/Division-Unit-Cell
Date 27
In discussion (recast) 1. Extension of the responsibility of the EMA to
medical devices and creation of a Medical Device Expert Group at this agency;
2. Creation of a new EU regulatory agency for medical devices only and of a Medical Device Expert Group at this agency;
3. Management of the medical device regulatory system by the European Commission and creation of a Medical Device Expert Group supported by this institution;
4. Creation of a Medical Device Expert Group managed by Member States
Evaluation - European Expert Group
Subject famhp/entity/Division-Unit-Cell
Date 28
Strenghtening of assessments and controls of notified bodies
• Stricter and detailed requirements to be met by Notified Bodies – Recast Annex VI
• In regular intervals, monitoring of Notified Bodies including ‘joint assessments’ (experts from other MS and EC)
Evaluation – Notified bodies
Subject famhp/entity/Division-Unit-Cell
Date 29
Materiovigilance
• Contact points network for hospitals
• Contact points network for companies
Materiovigilance network
Hospital Distributors
FAMHP
CP
Materiovigilance
CP
Subject famhp/entity/Division-Unit-Cell
Date 30
Materiovigilance
Objectives of the contact points • Better orientation of all messages related to
materiovigilance
• More specificity
• Direct to the right person
• Privileged interlocutor with the authority
Subject famhp/entity/Division-Unit-Cell
Date 31
Materiovigilance
• Standard (european) procedures for evaluation and notification of risks / incidents
• Sensibilisation of the actors
• Optimalisation of the assessment of incident
Subject famhp/entity/Division-Unit-Cell
Date 32
Other axes
Transparency • Involvement of patient representatives • Discussion about the publicity rules
Monitoring • Steering committee • Check the implementation for each action included
in the plan • FU of the working groups
Subject famhp/entity/Division-Unit-Cell
Date 33
Other axes
Legislation • New law and royal decree
Admnistrative simplification • One stop = famhp
⇒ Transfert of competencies from Economic affairs and ISP to famhp
Subject famhp/entity/Division-Unit-Cell
Date 34
Thank you!!!
Subject famhp/entity/Division-Unit-Cell
Date 35
Federal agency for medicines and health products - famhp
Place Victor Horta 40/40 1060 Bruxelles
tel. 0032 2 524 80 00 fax 0032 2 524 80 01
e-mail welcome@fagg-afmps.be
www.afmps.be
Contact
Your medicines and health products, our concern
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