MINISTERS’ DEPUTIES

CM Documents

CM(2019)32

6 February 2019[1]

1339th meeting, 6 March 2019 6 Social Cohesion   6.1 European Directorate for the Quality of Medicines and HealthCare (EDQM) [2] ‒ a. European Committee on Pharmaceuticals and Pharmaceutical Care (Partial Agreement) (CD-P-PH) Abridged report of the 14th meeting (Strasbourg, 18-19 September 2018) Item to be considered by the GR-SOC at its meeting on 28 February 2019

 

 

Opening of the meeting and adoption of the agenda

1.         The European Committee on Pharmaceuticals and Pharmaceutical Care (Partial Agreement) (CD-P-PH) held its 14^th meeting in Strasbourg on 18-19 September 2018 with Mr Emanuele Cesta in the Chair.

2.         The agenda of the meeting is contained in Appendix 1. The full report of the meeting, including the list of participants, is available from the EDQM.

Election of the Chairperson and Vice-Chairperson

3.         The Committee voted unanimously to elect Mr Cesta (Italy) as Chair and Mr Zelić (Serbia) as Vice-Chair.

List of items for information of the Committee of Ministers

4.         No conflicts of interest relevant to the subject of the meeting were disclosed by the participants at the start of the meeting.

General items

Restructuring of the Biological Standardisation, Official Medicines Control Laboratories (OMCL) Network and HealthCare Department (DBO)

5.         The delegates took note of the new organisational chart and changes in the structure of the DBO department, including the appointment of Ms Hecquet as Head of Section as of 1 January 2019.

Fact-sheet highlighting structure and activities of the CD-P-PH and its subordinate committees of experts

6.         The delegates took note with appreciation of the fact-sheet that was prepared by the Secretariat with the overall goal to provide new delegates with an overview of the Council of Europe and EDQM along with information on the structure and roles of the Secretariat, the CD-P-PH and its supporting committees of experts.

Committees’ satisfaction survey results

7.         The delegates discussed the results of the Committees’ satisfaction survey, which was circulated among the CD-P-PH, CD-P-PH/CMED, CD-P-PH/PC and CD-P-PH/PHO members in January 2018. Analysis of the results related to the CD-P-PH showed that overall delegates are happy with the functioning of the committee, meeting content and set-up, on-going projects, and the Secretariat’s support.

Communication and dissemination strategy

8.         Discussion took place about the need for a communication strategy for the work of the CD-P-PH and its committees of experts with a view to increasing awareness of and promoting the outcomes of the committees’ work as well as encouraging participation in their activities. It was agreed to draft a position paper/guidance document with the support of the Vice-Chair and the Secretariat.

Gender equality (GE) discussion

9.         The CD-P-PH took note with appreciation of the presentation of Mr Cesta (GE Rapporteur). The presentation provided an overview about gender mainstreaming activities in the Council of Europe and Mr Cesta’s 2^nd year of experience as GE Rapporteur.

10.       The Secretariat reminded the delegates that the Council of Europe requests that each steering committee appoints a GE Rapporteur who is in charge of looking into the activities of the steering and subordinate committees and identifying areas relevant for gender equality.

PaedForm project

11.          Mr Leutner (Secretary to the PaedF Working Party) and Mr Breitkreutz (Chairman of the PaedF Working Party) gave a presentation aimed at explaining the status of the PaedForm project. To date two draft monographs (i.e. Hydrochlorothiazide 0.5 mg/mL oral solution and Sotalol hydrochloride 20 mg/mL oral solution) and two explanatory documents (i.e. General principles and Introduction) have been elaborated. A public consultation will be launched in October 2018 to collect comments about the above documents. The final texts will be tabled for adoption by the European Pharmacopea Commission (expected timeline: 1^st half 2019) and CD-P-PH (expected timeline: 2^nd half 2019).

Subordinate Committees

Committee of Experts on Minimising Public Health Risks Posed by Falsification of Medical Products and Similar Crimes (CD-P-PH/CMED)

12.          The Secretariat briefly presented the main outcomes of the 20^th and 21^st meetings of the Committee of Experts CD-P-PH/CMED. The following points were highlighted: a) 20^th meeting: 1-day meeting adjacent to the SPOC KnowX workshop with discussions mainly focused on the workshop outcomes and follow-up; b) Single Points of Contact (SPOC)-KnowX workshop: the event, hosted by the Belgian Federal Agency for Medicines and Health Products (FAMHP) (Brussels, 5-6 December 2017), which stimulated the following outcomes: 1) SPOC network: overall agreement on the need to strengthen the network, importance of having regular training for setting-up and maintaining a good network, and need to develop a best practice/guidance document to outline the role of a SPOC contact. 2) KnowX database: presentation of the KnowX updated version and discussion on how to implement it within the network and use it as an operational tool for the network. 3) International cooperation: identification of two levels of cooperation (operational level and regulatory level) and consensus reached on the fact that there is no need to create a ‘super-organisation’ (rationale: each international organisation active in the field has its own purpose and network) and that key representatives of each international organisation should be encouraged to proactively exchange information about each other’s activities; c) 21^st meeting: 2-day meeting with the addition of an additional day for the private stakeholders. Election of a new Chair-person and Vice-chairperson took place with unanimous agreement on a co-chairmanship (the Netherlands and Serbia) (Vice-Chairmanship: UK). Discussion took place regarding the reorganisation of the working methods relating to the CD-P-PH/CMED activities leading to the decision to create teams to work on specific topics. Successful third day of the meeting with a lot of interest from the private stakeholders in the CD-P-PH/CMED work.

13.          The CD-P-PH took note with appreciation of the overview of activities from the Secretariat and approved the conclusions of the reports of the 20^th and 21^st meeting of the Committee of Experts CD-P-PH/CMED.

MEDICRIME Convention

14.          The Secretariat informed the delegates that 13 countries have currently ratified the MEDICRIME Convention with the possibility of Switzerland ratifying it in 2019. A lot of interest in the Convention had been expressed from African countries and an official request to adhere to MEDICRIME had been submitted by the Republic of the Congo and the Ivory Coast. Attention was also drawn to the fact that discussions are on-going regarding the establishment of the Committee of the Parties (i.e. the Convention’s monitoring body).

15.          The delegates asked the Secretariat to be kept informed of any developments in relation to the setting up of the Committee of the Parties.

Organisation of a MEDICRIME event

16.          The Secretariat informed the delegates that the organisation of a high-level MEDICRIME event is currently under consideration. The event could be potentially held in 2020 and aim to raise awareness on falsification of medicinal products and similar crimes and their negative impact on public health as well as encourage states to sign and ratify the MEDICRIME Convention. The Secretariat invited all delegates to consult back home about the need for and feasibility of convening such an event.

Committee of Experts on the Classification of Medicines as Regards their Supply (CD-P-PH/PHO)

17.          The Secretariat briefly presented the main outcomes of the 63^rd and 64^th meetings of the Committee of Experts CD-P-PH/PHO. The following points were highlighted: a) Renewal of the 2018-2019 Terms of Reference (ToR) and publication of an overview of the results achieved during the 2016-2017 ToR; b) Renewal of the terms of office in 2018 of Ms Hadjihamza, Chairperson and delegate of “the former Yugoslav Republic of Macedonia”, and of Mr Pongratz, Vice-Chairperson and Austrian delegate; c) Decision not to organise an event in 2018 and agreement to resume the discussion on this matter in 2019; d) Completion of the evidence-based reviews focusing on the ATC group G01AF (Imidazole derivatives) and ATC group M01 (Anti-inflammatory and anti-rheumatic products), and evidence-based reviews focusing on the ATC group N02B (Other analgesics and antipyretics) and ATC group R01 (Nasal preparations) currently in preparation; e) Updates of the Melclass database with respect to the national classification of medicines belonging to ATC groups A11DB (Vitamin B1, combinations), G04BE (Drugs used in erectile dysfunction) and V (Various); f) Ongoing monitoring and discussion of the recommendations and referrals coming from the Pharmacovigilance Risk Assessment Committee (PRAC) and Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

18.          No comments were received and the CD-P-PH approved the conclusions of the reports of the 63^rd and 64^th meeting of the Committee of Experts CD-P-PH/PHO.

Resolution CM/Res(2018)1 on the classification of medicines as regards their supply

19.          The delegates took note that the revised resolution was adopted by the Committee of Ministers in April 2018. An article was published in the Pink Sheet in June 2018 focusing on this revised text giving visibility to the resolution and provoking contact from some member states and stakeholders requesting further information. In November 2018 a bilateral meeting will be held involving the Secretariat, CD-P-PH/PHO Vice-Chair and Association of the European Self-Medication Industry (AESGP) to discuss the changes that were introduced in the revised text of the above resolution.

Co-operation between the Committee of Experts CD-P-PH/PHO and the CMDh Non-Prescription Medicinal Products Task Force

20.          The Secretariat informed the delegates that the CD-P-PH/PHO is invited to attend the meetings of the CMDh Non-Prescription Medicinal Products Task Force in its capacity as observer. In addition, at the 64^th meeting of the CD-P-PH/PHO the Chairperson of the Task Force proposed organising a joint meeting in 2019/2020 inviting stakeholders to explain the mission and work of the CD-P-PH/PHO and CMDh Task Force.

21.          The CD-P-PH encouraged the Committee of Experts CD-P-PH/PHO to consolidate its efforts to foster its collaboration with the CMDh Task Force. The delegates also invited the CD-P-PH/PHO to look into the possibility of organising a joint meeting with the Task Force with a view to highlighting the complementarity of the roles of these two groups of experts.

Committee of Experts on Quality and Safety Standards in Pharmaceutical Practices and Pharmaceutical Care (CD-P-PH/PC)

22.          The CD-P-PH approved the conclusions of the reports of the 80^th and 81^st meetings of the Committee of Experts CD-P-PH/PC.

Automated Dose Dispensing (ADD) Guidelines

23.          The delegates took note that the ADD Guidelines were published in February 2018 and are available for download from the EDQM FreePub website.

Resolution CM/Res(2016)2 on good reconstitution practices in health care establishments for medicinal products for parenteral use

24.          The delegates took note that the above resolution was presented at the annual conference of the European Association of Hospital Pharmacists (EAHP) in 2017 and again in 2018 where the presentations were very well received. In addition, during the summer months a scientific article was prepared with the support of a consultant and the CD-P-PH/PC Chairperson, and submitted for publication in the European Journal of Hospital Pharmacy in August to raise awareness about the resolution.

Pharmaceutical Care Resolution Project

25.          The Secretariat provided an overview about the status of the Pharmaceutical Care Resolution Project. The project is progressing well though in 2017 the work was carried out at a distance. A draft resolution is currently available, which should be finalised during a face-to-face meeting of the Pharmaceutical Care Resolution Working Party in November or December 2018. The draft will be tabled at the CD-P-PH/PC meeting for comments (spring 2019) and then at the CD-P-PH meeting for feedback and adoption (autumn 2019). The final step will then be the adoption of the resolution by the Council of Europe Committee of Ministers.

New projects

26.          The Secretariat informed the delegates that the following new project proposals are currently under consideration by the Committee of Experts CD-P-PH/PC: a) Cannabinoids and cannabidiol (aim: map the current situation related to the legal status and use of cannabis-derived products for medicinal purposes); b) Vaccination strategy (aim: potentially contribute to the objectives of the European Commission to improve the acceptance of vaccinations by the general population in member States; c) Cytotoxic treatment surveillance (aim: homogenise current processes related to handling, preparation and administration of cytotoxic medications); d) Medication review (aim: map the current situation related to medical review practices in Europe as well as develop guidelines/templates for it); e) Traceability of medicines in hospitals (aim: potential development of a system to ensure full traceability of medications within the hospital environment).

Any other business

New project proposal – Patient information leaflets

27.          Mr Magnusson presented a project proposal focusing on ways to facilitate access to the necessary information on medicine packages and leaflets for patients and minority groups of consumers who do not understand the national language of the country where medicines are prescribed, dispensed and distributed to them. The CD-P-PH thanked Mr Magnusson and approved this project for presentation to the Committee of Experts CD-P-PH/PC at its next meeting (28-29 November 2018).

Date and venue of the next meeting

28.       The CD-P-PH agreed to hold its 15^th meeting on 10-11 September 2019. Running up to this meeting a teleconference will be organised before the summer break 2019.

Appendix 1

Agenda

1.             Opening of the meeting and adoption of the agenda

2.             Report of the last meeting

3.             Election of the Chairperson and Vice-Chairperson

4.             General items

5.             Gender Equality discussion

6.             PaedForm Project

7.             Subordinate Committees:

7.1       Committee of Experts on Minimising Public Health risks Posed by Falsification of Medicinal Projects and Similar Crimes (CD-P-PH/CMED)

7.2       Committee of Experts on the Classification of Medicines as Regards their Supply (CD-P-PH/PHO)

7.3       Committee of Experts on Quality and Safety Standards in Pharmaceutical Practices and Pharmaceutical Care (CD-P-PH/PC)

8.         Open discussion on the need for new projects

9.         Any other business

10.       Date and venue of the next meeting