SUBMITTED TO THE COMMITTEE OF MINISTERS FOR FOLLOW-UP
The Committee of Ministers, in its composition
restricted to the Representatives of the member states of the Partial
Agreement in the Social and Public Health field,
is invited to:
consider the opinion on Parliamentary Assembly Recommendations
1445 (2000) on health security for Europe's population and 1446
(2000) on ban on antibiotics in food production (Appendix II to this
consider draft Resolution ResAP(2001).. on the pharmacist's
role in the framework of health security (Appendix III to this report)
with a view to its adoption.
Decisions of the Committee of Ministers
The Committee took note of the decisions of the Committee of
Ministers, adopted at the 717th and 724th
meetings, concerning the Public
2. The Committee adopted
an opinion on Parliamentary Assembly Recommendations 1445 (2000) on
health security for Europe's population and 1446 (2000) on ban on
antibiotics in food production (Appendix II to this report) and
transmitted it to the Committee of Ministers.
Committee of experts on pharmaceutical questions (P-SP-PH)
The record of the 46th session of the Committee of
experts on pharmaceutical questions was approved.
The draft Resolution ResAP(2001).. on the pharmacist's role
in the framework of health security (Appendix III to this report) was
approved and submitted to the Committee of Ministers for adoption.
The Committee took note of the publication of the
“Stocktaking” and the “Proceedings” related to the Seminar on
“The Pharmacist at the crossroads of new health risks: an
indispensable partner for their management!”, held in October 1999.
Committee of experts on nutrition, food safety and consumer
The record of the 4th meeting of the Committee of
experts on nutrition, food safety and consumer health was approved.
The Committee agreed to hold an international forum on food and
nutritional care in hospitals in November 2001.
It instructed the Committee of experts to consider holding an
international forum on the nutrition of children already in 2002, if
Committee of experts on materials coming into contact with food
The record of the 38th meeting of the Committee of
experts on materials coming into contact with food was approved.
The Committee noted that a new concept for the safety
evaluation of substances associated with resolutions on food contact
materials and articles was under preparation.
It noted that the Committee of experts was of the opinion that
in order to ensure food safety and consumer health, the toxicological
evaluation of food contact substances should be given the highest
priority in the work programme of the Public Health Committee.
It noted that the Committee of experts was currently preparing
the procedure for the submission of dossiers on food contact
substances to be evaluated and that the establishment of a Working
Party responsible for the safety evaluation of substances was under
It noted that the Committee of
experts had stressed the need for the necessary budgetary funds to be
allocated by the Committee of Ministers for the safety evaluation of
food contact materials.
It noted that it was envisaged
by the Committee of experts to finalise the new concept for safety
evaluation of food contact substances by the end of 2001 or spring
It decided that the finalised concept for safety evaluation of
food contact substances and the relevant budgetary needs should be
submitted to the Public Health Committee for follow up.
Committee of experts on flavouring substances (P-SP-AR)
The record of the 47th meeting of the Committee of
experts on flavouring substances was approved.
The Committee noted that Report No. 1 on natural sources of
flavourings, providing safety-in-use evaluations of 101 source
materials, had been published in July 2000.
3. It noted that the 4th
edition of chemically-defined flavouring substances, published in
1992, would be re-edited by the end of 2000.
Committee of experts on cosmetic products (P-SP-CO)
record of the 34th meeting of the Committee of experts on
cosmetic products was approved.
Ad hoc group of experts on health protection against dangers of
Committee decided to convene an ad hoc group of Experts
entrusted with the drawing up of a draft resolution on the protection
of the health of the population in general against dangers of
The Spanish delegate asked that the information of the
Partial Agreement Website should be available through links by
web-search engines, such as Yahoo.
Date and venue of the next session
agreed to hold its 67th session on Thursday 21 June 2001 in
conjunction with the CDSP's meeting.
concerning the pharmacist's role in the
framework of health security
by the Committee of Ministers
… … 2001
the …th meeting of the Ministers' Deputies)
Committee of Ministers, in its composition restricted to the
Representatives of Austria, Belgium, Cyprus, Denmark, Finland, France,
Germany, Ireland, Italy, Luxembourg, The Netherlands, Norway,
Portugal, Slovenia, Spain, Sweden, Switzerland and the United Kingdom,
Member States of the Partial Agreement in the Social and Public Health
Resolution (59) 23 of 16 November 1959, concerning the extension of
the activities of the Council of Europe in the social and cultural
regard to Resolution (96) 35 of 2 October 1996, whereby it
revised the structures of the Partial Agreement and resolved to
continue, on the basis of revised rules replacing those set out in
Resolution (59) 23, the activities previously carried out and
developed by virtue of that resolution, these being aimed in
raising the level of public health protection in its widest
sense, including a constant contribution – in the field of products
having a direct or indirect impact on the human food chain as well as
in the field of pesticides, pharmaceuticals and cosmetics - to
harmonising legislation, regulations and practices governing, on the
one hand, quality, efficiency and safety controls for products and, on
the other hand, the safe use of toxic or noxious products;
integrating people with disabilities into the community: by
defining, and contributing to the Europe-wide implementation of, a
model of coherent policy for people with disabilities, taking
simultaneous account of the principles of full citizenship and
independent living; and by contributing to the elimination of all
types of barrier to integration, whether psychological, educational,
family-related, cultural, social, professional, financial or
regard to the action carried out for several years for the purpose of
harmonising legislation in the public health field and, in particular,
in the pharmacy sector;
in mind the measures proposed in Resolutions AP (93) 1 on
the role and training of community pharmacists, AP (94) 1 on the
rational use of medicines and AP (97) 2 on the development
of the function of pharmacists and the adaptation of their initial
training, and the need to implement them;
in mind the proceedings of the Seminar on “The pharmacist at the
crossroads of new health risks: an indispensable partner for their
management!”, held at the Council of Europe in Strasbourg from 20 to
22 October 1999;
the emergence of new therapies with their associated risks;
that iatrogenic effects, including medication errors, are not only a
public health problem but also lead to increased health expenditure;
the growing trend towards self-medication;
the dangers inherent in counterfeit products;
the problems posed by distance sales of medicinal products and the
of this practice through the Internet;
the challenges of new information technologies;
the need to ensure that the application of technological progress
benefits the patient;
that pharmacists provide added value both through their scientific and
pharmaceutical expertise and in terms of ethics;
the need to promote the pharmacist's role in the management of new
that community pharmacists are the health professionals most readily
accessible to patients and that they help to personalise the delivery
of patient care;
that pharmaceutical care helps to reduce iatrogenic risks, including
the need to take professional services into account in the
remuneration of pharmacists;
that health expenditure must not be curbed at the expense of quality
that regulations need to be adapted to address the emergence of new
health risks and the development of the pharmacist's role in their
that the governments of the member States of the Partial Agreement in
the Social and Public Health Field take the following principles into
consideration for the purpose of adapting their regulations to reflect
the pharmacist's developing role in relation to health security, and
that they encourage pharmacists, professional bodies, academic
institutions, health insurance funds and patients' and consumers'
associations to take them into account:
with the developments in communication systems and
scientific progress, there is a risk of less personal contact.
Patients, as of right, should be able to have direct contact with a
pharmacist. It is also essential to establish co-operation through
networks linking pharmacists, health authorities and other health
professionals. Pharmacists must be able to function freely and
dispassionately within these networks. The system under which they are
remunerated must be reviewed to reflect the professional service they
provide rather than the profit margin or volume of their sales, in
accordance with Resolution AP (93) 1 on the role and
training of community pharmacists. Pharmacists' basic and
further training should include behavioural sciences and
health spending cannot be curbed at the expense of quality of
care. In order to reconcile quality with the need to keep costs down,
the contribution of the pharmacist to quality improvement and cost
control should be recognised and the regulatory framework should
ensure a role for pharmacists at every stage of the medication chain;
one of the pharmacist's basic functions, as an expert in
medicinal products, is to help prevent avoidable iatrogenic risks.
There are various means of reinforcing the pharmacist's role in this
respect. An epidemiological network on medication errors, involving
pharmacists and other health professionals, must be set up, with
systematic notification. Pharmaceutical care and clinical pharmacy (in
hospitals and community pharmacies and in primary healthcare) should
also be developed. The pharmacist's role as a supplier of
information to prescribing doctors, patients and other health-care
providers must be strengthened. In particular, pharmacists must give
patients not only oral but also written advice on the proper use of
Pharmaceutical care is an essential element in the prevention
and reduction of iatrogenic risks and should be implemented
systematically. It includes:
the keeping of pharmaceutical records that contain details of
the patient's case-history, medicines supplied, clinical
information, available therapeutic and biological results, and
recommendations made to the patient;
the monitoring of prescriptions, particularly in the light of
the patient's pharmaceutical record in order to check for
consistency and for possible interactions with other medicines;
the evaluation of patients' overall medication;
the rationalisation of the advice given to patients: procedures
must be developed whereby, in particular, patients will in certain
circumstances receive information in writing;
the systematic exchange of information with other health
professionals (via networks).
In order to achieve these tasks, full use should
be made of the various information technologies and relevant
databases, and it should be possible to access patient profiles and
incorporate them in pharmaceutical records.
The risks associated with self-medication can be reduced if
patients are well informed and pharmacists have an important role in
the process. The pharmacist must inform the patient about significant
interactions. Moreover the patient must be informed about the risks
associated with “borderline” products and medicines available
outside pharmaceutical control, both by health professionals and
through information campaigns.
Pharmacists must evaluate all patient requests.
They must be able to rely on guidelines including criteria for
evaluating the patient's condition and offering advice. Pharmacists
must, if necessary, put their opinions in writing and, with the
patient's agreement, address them to his or her doctor.
Where a patient record is kept, it should also
include information about self-medication.
Given the high risks inherent in new therapies, such as gene
and cell therapies, it is
draw up a set of good practices in co-operation with all the
professionals concerned, and monitor their implementation;
ensure, at every level, that therapeutic protocols are
documented in detail and verified;
set up multi-disciplinary teams that will make the best
possible use of their members' different skills;
establish criteria for deciding when treatment is appropriate,
given the dangers and the high cost of such therapies;
ensure that there is an exchange of information between the
relevant health professionals inside and outside hospitals;
make mandatory the recording of all steps in the research,
production and use of pharmaceutical products resulting from genetic
The pharmacist, as one of the experts in the
management of healthcare risks, must be integrated at every stage and
play an active role in decision making.
As therapies are increasingly used to enable people to exceed
their natural capacities, rather than to treat their illnesses,
pharmacists must be given a greater role in discouraging such
practices. They must make patients aware of the inherent risks, and
evaluate their requests in the light of their patient record. Health
authorities must organise campaigns to inform people about the dangers
of using medicines in this way.
Counterfeit pharmaceuticals pose real threats. In order to
combat these dangers, the authorities, manufacturers, wholesalers,
pharmacists and intergovernmental and non-governmental organisations
The authorities must:
set up systems of surveillance involving pharmacists at every
stage of the medication chain;
require that a person (as a rule a pharmacist) be made
responsible for quality at each stage of the distribution process;
reinforce the system of inspection of manufacturers' and
act against uncontrolled importation, distribution and
take a cautious approach to the opening of markets and to
develop packaging that makes falsification difficult;
recognise the need to lodge complaints about counterfeiting as
a matter of course;
when they are victims of counterfeiting, notify the health
authorities and those responsible at every stage in the distribution
Pharmacists must take due care in choosing their
Patients must be made aware of the inherent
dangers of counterfeit medicines.
Public health authorities should guarantee the quality, safety
and efficacy of medicines on the market. But such guarantees are
jeopardised by certain practices related to the Internet, as well as
by illicit importation and illegal distance sales.
A specific set of pharmaceutical good practices
for the Internet (GIP) must be drawn up.These should, in particular,
be implemented by those governments contemplating the sale of
medicines by Internet. If necessary, they should guarantee real (as
opposed to virtual)
contact between the patient and a health
International legislation should be drawn up, or
in its absence the legislation of the country of final sale should
prevail over that of the country of origin.
With regard to information and advertising, it is
necessary to introduce an accreditation system and a quality mark.
Consumers must be made aware of the issues, both
individually and through mass information campaigns.
Public health authorities should use the Internet
to direct the public to reliable information.
In order to optimise patient care, networks should be set up
including hospital and community pharmacists and those working in
primary healthcare teams, doctors
and, where appropriate, health authorities, health insurance funds and
universities. They must also facilitate co-operation between
professionals inside and outside hospitals.
The primary aim of such networks must be to serve
the patient's interests.
It should be ensured that:
patient retains freedom of choice;
patient data is confidential and only selected parties have
access to it;
network quality and security criteria are established, and
networks are validated and compatible;
levels of responsibility are determined.
The use of new technology will also make it
easier to keep patient records and monitor
In order to achieve these aims, the basic and further training
of the various practitioners involved must be adapted on an ongoing