Professional Documents
Culture Documents
Contents
1
Words from the President
Dr Gesine Klein
Towards sustainable standards:
the global context
4
Activity report 2017
Towards sustainable standards
6
Pharmacopoeia
Setting pharmaceutical standards
for homeopathic preparations in
the European Pharmacopoeia
8
Regulatory environment
Quality and safety:
working with HMPWG
10
Our sector
Joining the debate
11
Inside ECHAMP
12
Map of ECHAMP members
—
At a crossroads: complementary
Words from the President medicine and its medicines
The situation
Dr Gesine Klein of market
Globalisation is advancing in rapid strides, manifest in
–
public discussion. Complementary medicine systems are access for these
Towards no exception: homeopathy, anthroposophic medicine, medicines is not
Ayurveda, traditional Chinese medicine and acupuncture yet satisfactory.
sustainable are all attracting interest from patients, doctors, practi-
tioners and health institutions around the world.
standards: the The emerging economies of the BRICS countries,
specifically Brazil, India and China, are playing a leading
global context role in this respect. In Europe, Switzerland is moving
ahead in a systematic way.
“Continued dialogue is needed For Europe’s citizens and for its industry, the question is:
to create balanced regulation To what extent is the European Economic Area
that works in an increasingly committed to upholding its own traditions,
homeopathy and anthroposophic medicine ?
global context.”
• How far do European patients have freedom of choice
of therapy while being guaranteed a maximum level Dr Gesine Klein,
of safety ? President,
ECHAMP
• To what extent is there a common market for homeo-
pathic and anthroposophic medicinal products ?
• How strong is the European home base of homeopathy
and anthroposophic medicine when faced with global
competition of therapies ?
For ECHAMP and its member companies comes the
additional vital question:
How far is the integration of homeopathic and
anthroposophic medicines in Europe supported by
an appropriate regulatory base for market access ?
The 2017 report by the Homeopathic Medicinal Products
Working Group (HMPWG) on the regulatory status of
homeopathic medicinal products (see page 4) shows a
highly diverse picture of the regulatory and market
situation of these medicinal products. The facts it pre-
sents complement the findings of ECHAMP’s 2013
report, The Availability of Homeopathic and Anthroposophic
Medicinal Products in the EU: the situation of market access
for these medicines is not yet satisfactory. ➝
1
— The EU goal of guaranteeing quality, safety and effective- Without sufficient dialogue, the risk is top down regula-
A constructive ness of homeopathic and anthroposophic medicines can tion, unworkable in the real world and downgraded
dialogue with only be met if workable and sustainable standards balance authority of the agencies, undermining the results of
the needs of the state (regulators) with the reality of the regulatory investments. Failure to achieve a good balance
competent and market (industry), prescribers and users. Otherwise between state regulators, industry and patients can result
empowered regulations will hinder the position of EU-based industries in overregulation, either leading to lack of availability and
bodies of and their services. a black market, or favouring monopolist industry.
regulators will All stakeholders seem to share the perception that im- True consensus is not easy. Every change of quality control
provements are necessary and all, including the EU parameters has an economic impact on industry. Good
be essential to institutions, the 28 Member States and the providers will, discipline, a robust process and transparent decision
proceed. of products and services, share a responsibility to find making will be required, as will a thorough understanding
solutions. of the sector by regulators.
In 2017, ECHAMP and its members continued to work at This will allow the sector to grow and develop, so that it
different levels to improve this situation, investing can take its place side by side with other complementary
considerable resources into the development of sustaina- medicine therapies, ensuring the continued availability of
ble standards. Solutions for the issues addressed high quality medicines and their therapies for the patients
are within the competence of the bodies of the EU and who want them.
Member States and of the European Pharmacopoiea.
To achieve progress, a well-structured, constructive
dialogue is essential.
It is a joint challenge to develop coherent, sustainable
standard setting that better balances public health require-
ments with market needs. A constructive dialogue with
competent and empowered bodies of regulators will be
essential to progress. Only in this way can we achieve a
consensus in the sector that can be acknowledged as
rational and consistent.
Sweden
Finland
Norway
Estonia
Latvia
Lithuania
Denmark
Netherlands
United
Ireland Kingdom Poland
Germany
Belgium Czech
Republic
Slovakia
Full Member of ECHAMP
Italy Bulgaria
Spain
Portugal
Greece
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