Presentation of the GMC. Dieter Deforce

Transcription

1 Presentation of the GMC Dieter Deforce

2 Mission - Ensuring, the quality, safety and efficacy of medicines for human use - Help in a timely access to new therapies (Unmet Medical Need), with best interest of patient in mind - Advisory commission 2

3 3 The new commission: legislative framework Advices given by Commission: Law on medicines adapted: Royal Decree of 14th december 2006 on medicinal products for human and veterinary use Change regarding to advices given: optional advice for variations focus on critical dossiers only, to allow scientific discussion where needed 3

4 4 The new commission: competences Changes: Extension of competences: Previous competences: Marketing authorisations (MA) Compassionate use and Medical need programs (Unmet Need) (UMN) Safety reports Risk management plans, risk minimisation activities Scientific Advice on general matters New Competences: Clinical Trial applications (CTA, informal) Scientific technical advice (STA, informal) Advanced Therapeutic Medicinal Products (ATMP s) - Hospital exemption 4

5 5 Not the remit of the commission - pricing/reimbursement - Marketing - commissie van toezicht op de reclame 5

6 6 Commission FAGG/FAMPH - FAGG/FAMPH staff prepares reports and presents to commission - For each report a coodinator within the commission is appointed - - Members and FAGG staff - Report is accepted/amended by the commission 6

7 7 The new commission: composition 8 effective members right to vote Each member has an alternate Additional members can be co-opted 7

8 Vice-president Prof. Dr. Yves Horsmans UCL Gastro-entérologie, Hépatologie, Tumeurs hépato-bilio-pancréatiques, 8

9 Member Prof. Dr. Joeri Aerts VUB immunotherapeutic approaches for treatment of cancer and HIV infection. 9

10 Member Prof. Isabel Spriet UZ Leuven Hospital Pharmacist special interest in antimicrobial pharmacokinetics/pharmacodynamics. 10

11 Member Prof. Dr. Karel Allegaert KULeuven clinical pharmacology in pregnancy and in paediatrics; neonatal and pediatric intensive care 11

12 Member Prof. Jutte van der Werff ten Bosch UZ VUB pediatric hemato-oncology and immunology 12

13 Member Prof. Dr. Jean-Marie Colet Université de Mons preclinical and clinical toxicology 13

14 Member PharmD. Manon Gillet CHU Liège Pharmacien hospitalier clinicien 14

15 Co-opted member Prof. Dr. An De Sutter UZGent family doctor with special interest in evidence based prescribing of medicines in primary care. 15

16 Alternate Member Prof. Dr. Bert Bravenboer UZ Brussel all-round general internist with special expertise in endocrinology and clinical pharmacology. 16

17 Alternate Member Prof. Kristien De Paepe VUB Pharmacist, Technology and Compounding, dosage forms, product formulation and excipients, patient communication 17

18 Alternate Member Prof. Gert Matthijs KULeuven Human genetics, molecular testing and diagnosis 18

19 Alternate Member Prof. Paul Declerck KULeuven Pharmaceutical quality, biotechnological drugs, monoclonal antibodies, biosimilars 19

20 Alternate Member Prof. Patrice Forget VUB, UZBrussel Anesthesiology, chronic pain management, clinical research 20

21 Alternate Member Prof. Christian Rolfo UA (Phase I- Early) Clinical Trials, Thoracic Oncology, Translational Oncology. New Biomarkers and resistance mechanisms in oncology. Liquid Biopsies. 21

22 Alternate Member Prof. Isabelle Vande Broek UA, AZ Nikolaas Diagnosis and treatment of hematological disorders 22

23 Alternate Member Stéphanie Bauduin General practice 23

24 2 4 The new commission: composition Additional experts can be invited ad hoc, without right to vote: - eg. geriatrics Consultative members advisory vote: Patient representation 4 members: LUSS (Ligue des Usagers des Services de Santé) NIC (Nationaal Intermutualistisch College) VPP (Vlaams Patiëntenplatform) Test-Aankoop Chief Executive Officer of the FAMHP Director General PRE-Authorization Director General POST Authorization Director General INSPECTION RIZIV/INAMI Ethics Committee representation 24

25 2 5 DOI and COI The DOI of all members has been assessed by the famhp. In certain dossiers, a member can participate in the discussion concerning the medicine in question or a competitor, but the member is not allowed to take part in the decision process (voting). At the start of each session, each member will be asked by the (vice)- president to declare any conflict of interest to the dossiers presented on the agenda. DOI of the members will be made publically available on the website of the famhp Kickoff meeting famhp/dg Pre 17/12/

26 Number of meetings Weekly meetings Meetings cancelled due to small number of dossiers: 26% Quorum was established in all the meetings 26

27 Number of dossiers treated by the commision 1st year active discussion VHP (voluntary harmonization procedure) 2 CTA (clinical trial application) 1 UMN 39 MA CP new 8 MA MRP new 4 MA DCP new 6 MA NP new 18 Variation CP 2 Variation MRP 3 Variation NP 12 referral 6 vigilance 4 other 19 total

28 Active discussions Focus on critical files decision based on internal decision matrix 28

29 Dossiers treated by the commision: active discussion other VHP/CTA Vigilance UMN Referral Variations MA 29

30 Legal context UMN Royal decree 25/04/2014 amending RD 14/12/2006 provides legal context for UMN programs Subsequent to member state implementation of EC regulation 726/2004, Art. 83 Compassionate use programs are limited to medicinal products that have no market authorisation, in any therapeutic indication, in Belgium. Medical need programs relate by shear nature to products that are authorised in Belgium for which: the sought indication has been obtained but the product is not yet commercially available in Belgium, or a demand to obtain the sought indication is ongoing, or clinical trials are ongoing in the sought indication. 30

31 Legal context MNP/CUP programs are restricted to patients with a life threatening disease, or a disease with a serious impact, or a chronic disease that cannot be treated satisfactorily by a product licensed for this indication and commercially available in Belgium. Also applicable when B/R of a novel product is considered significantly better than commercially available treatment options. 31

32 Legal context GMC must establish (legally foreseen criteria) whether alternative therapies are available to treat the condition, the justification why the proposed patient population cannot be adequately treated with available alternatives, the justification why the proposed patient population cannot enter a clinical trial [investigating the concerned product], the quality of the product, the pertinence of the non-clinical data of the product, the relevance of the clinical data of the product addressing the unmet medical need in the concerned indication. 32

33 Some key figures October 2016 Assessors s recommendation vs GMC decision Comparison advice Program N identical modified different N % N % N % Medical Need Compassionate Use Total

34 Some key figures October 2016 GMC vs ANSM (ATU) decisions Agency Total Identical indication Approved Rejected Invalid Retracted In assessment N N % N % N % N % N % N % FAMHP ANSM

35 other 3 hearings with industry 2 ad hoc working groups 35

36 federal agency for medicines and health products QUESTIONS???

37 Contact Federal Agency for Medicines and Health Products FAMHP Place Victor Horta 40/ BRUXELLES tel fax welcome@fagg-afmps.be 37