RAPPORTEUR GROUP

Social and Health Questions

GR-SOC(2018)17

8 November 2018[1]

European Directorate for the Quality of Medicines and HealthCare (EDQM) Information document prepared by the Secretariat Item to be considered by the GR-SOC at its meeting on 29 November 2018

 

 

Introduction

Every minute of every day, people around the world - of all ages and from all walks of life - need blood transfusions to survive, are being admitted to hospitals to be treated for an illness or are receiving a life-saving operation such as an organ transplant, are taking either prescribed or OTC medicines in their daily lives to treat or relieve unpleasant ailments - treatments for long term illnesses such as asthma or diabetes or for high blood pressure, heart problems or cancer.

Every minute of every day, people around the world are being vaccinated - in Europe alone, the seasonal flu vaccination prevents around 2 million people from getting the flu each year.

Every minute of every day, authorities around the world are seizing counterfeit or substandard medicines - removing them from circulation so that they do not endanger someone’s life or health.

Medicines and healthcare play a vital role in maintaining our health and wellbeing. The vision of the European Directorate for the Quality of Medicines and HealthCare (EDQM), Council of Europe, is “to protect public health by enabling the development, supporting the implementation, and monitoring the application of quality standards for safe medicines and their safe use which are recognised as a scientific benchmark and applied world-wide. The guidance and standards developed by the EDQM in the areas of blood transfusion, organ, cell and tissue transplantation and consumer health issues have a positive impact on public health in Europe and beyond.”

The work that the EDQM and its predecessors have been carrying out for almost 65 years was triggered by a flooding in 1953, causing more than 2000 casualties in Europe. This natural disaster was instrumental in changing the continent’s approach on how to work together to protect public health. It underlined the urgent need to create harmonised blood safety standards and prompted the Council of Europe to initiate an inter-governmental collaboration that translated into a series of Recommendations for the safe preparation and use of quality blood components that were subsequently ratified by member States. In addition, it triggered a wider and pressing need to harmonise standards concerning the quality of medicines within Europe and beyond, which resulted in the establishment of the European Pharmacopoeia.

Today, the Partial Agreement based on the Convention on the elaboration of a European Pharmacopoeia has 39 signatory parties, 38 member States[2] of the Council of Europe and the European Union. In addition, 30 observers, 28 countries form all continents[3], the World Health Organization and the Taiwan Food and Drug Administration, follow and/or participate in the work. The EDQM is in charge of a large portfolio of activities from the legally binding quality standards of the European Pharmacopoeia and the co-ordination of European networks of Official Medicines and Cosmetics Control Laboratories to providing the secretariat to five intergovernmental committees in the field of pharmaceuticals and pharmaceutical care, organ, tissue and cell transplantation, blood transfusion, cosmetics and consumer health protection as well as food contact materials which all have a common goal – to protect public health.

The intergovernmental work in the health field is well placed in the EDQM/Council of Europe, and constitutes an appropriate platform for co-operation through a spirit of dialogue and consensus. Its programme benefits from the unique human and social rights-based values and statute of the Council of Europe: member State legitimation and oversight, a choice of appropriate policy instruments and tools, and collaborative and multi-disciplinary working methods. All provide an excellent environment for useful and pragmatic outcomes, and constitute an invaluable asset for developing policies and model approaches for safer and more responsible healthcare systems in Europe. All member States of the Council of Europe and observers to the European Pharmacopoeia Commission are entitled to participate in these activities.

European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH)

The European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) supports the authorities of member States in times of increasing social gaps and resource constraints to make the medication process more safe, responsible and accessible to all who need it. Its work programme has three focus areas (fight against the falsification of medical products; pharmaceutical care and practices; classification of medicines as regards their supply, i.e. prescription/non-prescription medicines) and is accomplished with the support of three subordinate committees of experts. As the successor to the previous Public Health Committee, the CD-P-PH also exercises a general oversight of the activities of the European Pharmacopoeia Commission.

With reference to the fight against falsified medical products, the CD-P-PH promotes the MEDICRIME Convention and its implementation. It also serves as a platform for exchange of information and to promote co-operation. It supports and initiates projects aimed at disseminating best practices to protect public health from falsification of medicines and related crimes (e.g. organisation of training events and workshops; development and dissemination of strategies for risk communication).

In the pharmaceutical care field, the programme of activities carried out by the CD-P-PH aims to promote patient-centred care (e.g. development of indicators to monitor, assess and improve the medication use process and quality of care) and provide guidelines on safe and good use of medicines (e.g. best practices for the reconstitution of a medicinal product into a ready-to-use or ready-to-administer dosage form).

With respect to the harmonisation of the supply conditions of medicines in Europe, support is provided to member States by the CD-P-PH via the establishment of recommendations on the classification of medicines and their supply conditions. This work plays a crucial role in ensuring patient safety and accessibility of medicines in Europe.

The CD-P-PH and its subordinate committees co-operate with bodies of the European Union, the World Health Organization and other international and national organisations. The views of stakeholder associations and civil society are regularly sought and taken into account.

European Committee on Organ Transplantation (CD-P-TO)

Organ, tissue and cell transplantation is a complex and rapidly-evolving field, capable of saving and improving the lives of thousands of patients worldwide, but also having its own inherent challenges. These challenges include ensuring effective organisation, coordination and control of all crucial technical activities and services and safeguarding against exploitation and misuse. Since 1987, the European Committee on Organ Transplantation (CD-P-TO) has, through a number of initiatives, programmes and legal instruments, actively contributed to the development and implementation of quality, safety and ethical standards in the field, facilitating the exchange of knowledge between countries and institutions, securing fundamental rights and ensuring respect for the human body.

Over the years, a set of Resolutions and Recommendations in the field have been produced by the CD-P-TO and subsequently adopted by the Committee of Ministers. Although not legally binding, all these documents have profoundly impacted national legislations, ethical frameworks, strategic plans, organisational aspects and professional practices. In addition, the CD-P-TO has contributed to the drafting of the new Convention against Trafficking in Human Organs, which for the first time provides clarity on which practices must be prosecuted, strengthens existing mechanisms for co-operation and includes provisions to protect and assist victims. This is of the utmost importance considering that, according to the WHO, 5–10% of all transplants performed worldwide are the result of organ trafficking. Furthermore, through the establishment of an international network of National Focal Points on transplant-related crimes and an International Database on Travel for Transplantation, hosted by the EDQM, the CD-P-TO will gain a better knowledge of transplant-related crimes and will have the valuable opportunity to provide comprehensive and integrated information and recommendations on these matters at national and international level.

Monitoring of practices in the member States has become an evident need for the sake of transparency and international benchmarking. With this goal in mind, the CD-P-TO together with the Spanish Authority has since 1996 prepared the Newsletter Transplant on a yearly basis. This publication has evolved into a unique official source of information that continues to inspire policies and strategic plans globally. The newsletter summarises comprehensive data on donation and transplantation activities, management of waiting lists, organ donation refusals and authorised centres for transplantation activities. As of today, the Newsletter Transplant provides information from almost 70 countries worldwide.

The CD-P-TO is also responsible for the publication of specific technical guides in the field of organ transplantation and tissues and cells for human application. The most important professional associations in the field have actively participated in the elaboration and dissemination of these guides, which serve as invaluable tools for regulators and health professionals throughout Europe and beyond.

European Committee on Blood Transfusion (CD-P-TS)

Blood transfusion is an essential life-saving medical procedure widely used for severely injured people or critically ill patients. The activities in the field of blood transfusion started at the Council of Europe in the late 1950s following a severe flood that resulted in more than 2000 casualties. From the outset, activities were guided by the following principles: promoting voluntary and non-remunerated donations, mutual assistance, optimal use of blood and protecting both the donors and the recipients of labile blood components. The first result of this co-operation was the adoption of the European Agreement on the Exchange of Therapeutic Substances of Human Origin (European Treaty Series, No. 26) in 1958. Interestingly, some 60 years after its adoption, it is still proving to be a valuable legal instrument e.g. for the exchange of human convalescent plasma during the recent Ebola epidemic.

A number of Recommendations and Resolutions covering quality, safety and ethical aspects of blood transfusion have been submitted and adopted by the Committee of Ministers. Among these Recommendation No. R(95)15 and its technical appendix deserve to be singled out. The appendix consists of a comprehensive guide on quality assurance of blood components intended for blood services which was well received and immediately accepted by the transfusion field. Since then, this Guide for the Preparation Use and Quality Assurance of Blood Components is periodically revised to keep it in line with rapid scientific progress and regulatory changes. Nowadays it describes a set of harmonised standards that are the basis for national legislation in several Council of Europe member States and beyond, such as Australia and New Zealand. The 20^th edition of this Guide will be published in 2020.

In a joint Council of Europe / European Union project, common European standards for quality management systems in blood establishments were elaborated, published in the 19th edition of the Guide and subsequently made mandatory within the EU/EEA member States by Commission Directive (EU) 2016/1214. It is largely anticipated that these standards will be accepted on a global level as an outcome of the collaboration with the Pharmaceutical Inspection Co-operation Scheme.

Using information technology, a database of frozen blood units of rare blood phenotypes has been developed and made accessible to all blood establishments. It is a highly valuable tool which enables rapid searching for rare blood groups by facilitating bilateral contacts between blood establishments for the transfusion of patients needing a transfusion of red blood cells displaying a rare blood group phenotype.

Since 2011, a blood proficiency testing scheme (B-PTS) has been proposed to the blood establishments. It is co-financed by the European Commission. This activity uses inter-laboratory comparisons to determine the performance of blood establishments’ testing laboratories responsible for the screening of individual blood donations. It provides an independent external assessment of their performance in their testing capabilities. About 350 blood establishments have participated so far.

EU Directives request blood establishments to implement a quality management system. This is often regarded as an additional burden and, given the shortage of qualified resources in many blood establishments, assistance is dramatically needed in this field. Since 2012, a blood quality management (B‑QM) programme has been started to assist blood establishments in developing, implementing and improving their quality management system, while taking into account the specificities of the blood transfusion field. It is co-financed by the European Commission. Since the launching of the B-QM programme, 19 blood establishments benefited from it.

European Committee for Cosmetics and Consumer Health (CD-P-COS)

EDQM’s activities in this field focus on collaboration between members/observers with a view to protecting human health by:

-           strengthening market surveillance activities and enforcement;

-           identifying health threats and responding with common policies and coordinated actions, e.g. to remove products from the market that contain prohibited, often toxic substances.

National health authorities regularly check cosmetic products on the market for presence of components which are forbidden by national or EU legislation due to their toxicity or potential for causing allergic reactions (e.g. nickel in face paints for children or carcinogenic nitrosamines in nail polish).

A Network of Official Cosmetic Control Laboratories (OCCLs) was set up in 2010 which in 2018 accounted more than 40 laboratories (members and observers to the European Pharmacopoeia Convention) who participate regularly in testing campaigns and exchanges of technical expertise. When special techniques are not available in one laboratory, samples of cosmetics can be shipped to a fellow laboratory of the network that has the capacity and equipment to perform certain tests – thus saving time and resources. The OCCL Network also endeavours to establish common methods for the quality control of cosmetics. In 2017, collaborative trials were initiated to develop an in vitro test protocol that could be used to determine the Sun Protection Factor (SPF) of sun screens which is currently tested in humans.

Tattoos are of particular concern in the light of the quickly growing numbers of young people interested in this type of body painting. Some countries have regulations in place and the European Chemicals Agency is currently preparing restrictions for certain colourants. The Council of Europe already attempted in 2003 to set standards for enhanced quality of colourants and the 2008 Resolution described harmonised requirements for tattoo inks. An overview of the scientific knowledge and recommendations for toxicity testing was published in 2017.

European Committee for Food Contact Materials and Articles (CD-P-MCA)

Since the late 1980s, the Council of Europe has been active in the field of food contact materials and articles and has adopted Resolutions on the quality and safety of materials and articles that were not specifically regulated at the European level. The technical documents are periodically reviewed and updated on quality and safety requirements.

Common standards for consumer articles such as cutlery and kitchen utensils have been addressed in a practical guide for manufacturers and regulators which was first published in 2013. National enforcement authorities and well-known producers and retailers in Europe and beyond apply these standards. This was confirmed at an international symposium on food contact materials hosted by Slovenia in 2014. The European Commission recently adopted safe limits defined by Council of Europe guidelines for the revision of a Directive on ceramics.

Current challenges for EDQM’s intergovernmental committees

1.         The Terms of Reference (“ToR”) of the committees are established as per Resolution CM/Res(2011)24. Appendix 1 (rules of procedure, “RoP”), Article 5 states “there shall be a quorum if 2/3 of the members of the committee are present”. Article 11 states that “voting requires the quorum”. Where voting is necessary, the quorum is in most cases not reached and thus decisions have to be postponed to the next meeting where the same problem occurs. As the committees only meet once or twice a year this causes a significant delay of the work. Alternatively the voting has to be performed by e-mail but this approach is not really covered by Resolution CM/Res(2011)24. The EDQM would thus be grateful if the RoP could be changed so that the quorum would be reached if 50% of the members of the committee are present.

2.         In accordance with Resolution CM/Res(2011)24 on intergovernmental committees the term of office of the Chair and Vice-Chair shall be one year and it may be renewed once. The committees under the European Pharmacopoeia Partial Agreement only meet once or twice a year and the work they undertake is usually lengthy and could take several years to be completed. The possibility of having terms of office of two years, renewable would very much facilitate progress and continuity in the activities.

3.         For the committees under the European Pharmacopoeia Partial Agreement, their visibility within the organisation is limited. This is of particular relevance as Health and Healthcare are basic human rights that concern all human beings. EDQM suggests ensuring that proposals for resolutions and abridged reports of committee meetings are relayed to all appropriate national bodies in member States – not limited to those member States under the Partial Agreement of the European Pharmacopoeia.

In this context, it is important to note that Article 17 of Annex 1 of CM/Res(2011)24 allows for the possibility to make amendments to these rules.