The purpose of this article is to reflect on the Communication (COM(2008) 666) adopted and published by the EU Commission DG Enterprise and Industry on 10 December 2008 as part of the so-called Pharma-Package. This is directed towards the European Parliament and the Council of Ministers; it also addresses the European Economic and Social Committee and the Committee of the Regions. It proclaims a renewed vision for the pharmaceutical sector aiming at safe, innovative and accessible medicines.

The Commission Communication and the proposed legislation show important improvement intentions for the health care system in Europe. At first glance, the Commission’s vision statements on better access, better information and better regulation seem to support ECHAMP’s aims, as does the vision for better support for scientific and research development. These statements no doubt meet essential expectations and interests of European citizens. They also underline the need to strengthen research in Europe and to recuperate terrain lost to Asia and the US, meaning expressly globally active pharmaceutical companies and their economic interests on the grounds of patentable innovation.

However, the pharmaceutical platform from which the Communication departs leaves room and potential for structural improvement. This concerns both the pharmaceutical experts in Commission DG Enterprise and Industry and those in the Commission DG Sanco (Health and Consumer Protection).

The legislative proposals

The Communication contains three legislative proposals to amend Directive 2001/83/EC, the Community code relating to medicinal products for human use:

(i)   information to patients on medicinal products subject to medical prescription
(ii)  market surveillance of medicines (pharmacovigilance)
(iii) prevention of falsified medicines (counterfeit medicines).

There are now transpiring some concrete concerns of the industry for homeopathic and anthroposophic medicinal products with regard to these proposals, which will result in proposals for consideration and amendment. The two principle ones are:

-  that safety measures relating to conventional chemical active pharmaceutical ingredients (APIs) as well as the obligation to make extensive Periodic Safety Update Reports (PSURs) for medicinal products are not applicable to homeopathic and anthroposophic medicinal products with their long standing tradition of safety due to low concentration and soft regulative therapeutic action
- that falsification risks concern products with important sales volume considered ‘lifestyle products’ and treatments against life-threatening diseases.

Measures of protection must therefore concentrate on those medicinal products which clearly fall into the risk categories. They must consider exempting all medicinal products which are known for their positive safety profile. An undifferentiated across-the-board inclusion will create unaffordable cost burdens and consequently serious availability problems for patients and practitioners.

The 25 objectives

The Commission’s Communication focuses on three main subjects:

(i)  to make progress towards a single and sustainable market in pharmaceuticals
(ii)  to take on the opportunities and challenges of globalisation
(iii) to support scientific development for the benefit of the European patient.

There are 25 objectives which concern these three subjects and which are numbered and highlighted in the document. There are several which are relevant to homeopathic and anthroposophic medicines and the complementary health care approach with a view to better integration of complementary medicine in EU legislation and EU health politics. In particular:

-  optimising the network of EU medicines authorities (#2)
-  exchange of data between Member States on relative effectiveness (#5)
-  ensure availability and market access for […] non-prescription medicines (#6)
-  rationalise and strengthen the EU framework on pharmacovigilance (#9)
-  propose measures to reduce harmful impacts of pharmaceuticals on the   
   European environment and public health (#12)
-  improve international cooperation in the field of pandemics (#16)
-  using the EU-US Transatlantic Economic Council (TEC) for simplification […] and regulatory dialogue (#22).

Many of these objectives refer to the Pharmaceutical Forum, of which ECHAMP should certainly seek to be recognised as a partner.

As regards this latter objective (#22) in particular, ECHAMP could make a valuable contribution. In this forum, advantages of a most adequate system of legislation and regulation for homeopathic medicinal products could be discussed. In the United States, homeopathic medicinal products over decades have demonstrated overall positive safety aspects justifying a simplified and cost-efficient regulatory system. It entails full availability of the traditionally wide range of homeopathic and anthroposophic medicinal products to doctors, practitioners and patients all over the United States

This latter networking opportunity could indeed help to ‘bring closer the two biggest pharmaceutical markets in the world, lowering costs by reducing unjustified regulatory divergences’. It could increasingly work in favour of the important field of complementary and alternative medicine and its better regulation and integration into general European health care.

And finally, the Communication refers to ‘more personalised medicines’ (objective #25); however its focus is mainly on new technologies such as the wide range of genomics technologies. It would seem there is an urgent need to orient European health politics significantly more towards the traditional European and other health care solutions such as homeopathy, anthroposophic medicine and acupuncture, all of which have for many years promoted individualized and personalised medical care.

Max Daege
ECHAMP President