committee of experts cd-p-ph/pho activities and role

Committee of Experts CD-P-PH/PHO Activities and role

Viola Macolić Šarinić

Chairperson

Viola Macolić Šarinić © 2014EDQM, Council of Europe. All rights reserved.

Background

• The availability of medicines with or without a medical prescription has implications for: • patient safety, • the accessibility of medicines for patients • and the responsible management of health care

expenditure

Viola Macolić Šarinić© 2014 EDQM, Council of Europe. All rights reserved.

Background

• The decision on prescription status and related supply conditions is a core competency of national health (regulatory) authorities.


Background

• Pioneers in this field, the Council of Europe bodies have been concerned as from 1961 with issues relating to the classification of medicines into prescription and non-prescription medicines.


Council of Europe Committee of Ministers Resolution ResAP(2007)1 on the classification of

medicines as regards their supply

• The resolution text comprises a recommendation of the Committee of Ministers (Foreign Affairs Ministers, representing the governments of states participating in an activity) to member states to implement the stipulations of the resolution into national legislation or to adapt national legislation.

• Although recommendations are not legally binding, they are legal instruments; they may create soft law, and contain a political statement.

• The Committee of Ministers may also invite the member states to report on their efforts to implement a recommendation


• The classification criteria for the supply of medicinal products for human use set out in Council of Europe resolutions in this field were taken over by the:

• Council Directive 92/26/EEC of 31 March 1992

• Directive 2001/83/EC (Art 70-75) of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.

• In the preamble of later directive (item 32) reference is made to the Council of Europe:

• «…it is therefore appropriate to harmonise the basic principles applicable to the supply of medicinal products in the Community of member state concerned, while taking as a starting point the principles already established on this subject by the Council of Europe»

Speakers name ©yyyy EDQM, Council of Europe. All rights reserved.

Committee of Experts CD-P-PH/PHO


• Members:

• Governments of Council of Europe States Parties to the Convention on the Elaboration of the European Pharmacopoeia are entitled to appoint representatives from the relevant public authority.

• These may include experts responsible for the preparation and follow-up of national policies in the field of the legal classification of medicines. Each member state shall have one vote.

20 Active Members

(2011-2014) AUSTRIA (A), BELGIUM (BE), CROATIA (HR), CZECH REPUBLIC (CZ), GERMANY FINLAND (FL), FRANCE (FR), HUNGARY (HU), IRELAND (IE), ITALY (IT), LITHUANIA (LT), LUXEMBOURG, POLAND (PL), PORTUGAL (PT), ROMANIA (RO), UNITED KINGDOM (UK)

BOSNIA AND HERZEGOVINA (BiH),

F Y R OF MACEDONIA (FYRM)

SWITZERLAND, ARMENIA

Information about legal classification


• Other European institutions such as the: • European Medicines Agency (EMA),

• Deutsche Institut für Medizinische Daten und Information (DIMDI),

• WHO Centre for Drug Statistics Methodology

also provide information about the classification and supply status of medicines authorized in the EU via CP, DCP and MRP for marketing authorization (MA).

Workflow of the Committee


• Prior the meeting the Committee collects data on legal classification in MSs about: • Medicines with active substances and indications not yet

classified

• Medicines with new exemptions from prescription status/OTC status

• Medicines with active substances and indications for possible de-classification

• OTC medicines

Role of the Committee


• The Committee doesn’t issue recommendations on the classification of particular medicines but on active substances used in a medicine for a specific therapeutic purpose (INN/ATC).

Melclass database


• The Committee supervises a database, hosted by the EDQM which stores national information about the classification and supply conditions of medicines as well as the annually revised appendices to Council of Europe Resolution ResAP(2007)1.

• The information is publicly available.

• Recommendations about the classification of 2400 medicines are published in the database.

Melclass


http://www.edqm.eu/melclass/


Melclass


http://www.edqm.eu/melclass/Login.aspx

• Password: melclasscoe2005



MELCLASS - RESTRICTED SITE


Melclass


Evidence-based classification reviews

• http://www.edqm.eu/en/classification-of-medicines-1241.html#

http://www.edqm.eu/en/classification-of-medicines-1241.html




Melclass




Melclass


http://www.edqm.eu/melclass/Publication_Liste.aspx



MELCLASS - Public Site


Melclass


Appendix to Council of Europe Resolution ResAP(2007)1.

Aims of the Expert Workshop

• Understanding and learning about patients’ awareness, education and health literacy with respect to safe and appropriate use of OTC medications;

• Learning about new modes of medicinal products distribution, with special attention to distant trade of medicinal products;

• Examining possible regulations of supply modes of OTC medicines into “Pharmacy only medicines” and “General Sales medicines”;

Viola Macolić Šarinić©2014EDQM, Council of Europe. All rights reserved.

Aims of the Expert Workshop (cont.)

• Providing a platform for discussion of the regulatory, scientific and societal dimensions of the above topics;

• Identifying key elements of good medicines’ classification practices related to the above topics, taking into account the regulatory, scientific and societal dimensions;

• Confirming and promoting the CD-P-PH/PHO’s results as well as strengthening the CD-P-PH/PHO’s role and function in the European context, with a view to promoting medication safety and medication accessibility in Europe.

Viola Macolić Šarinić©2014 EDQM, Council of Europe. All rights reserved.

committee of experts cd-p-ph/pho activities and role

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