ALERT - first discussion of revision of pharmaceuticals directive
on 21 April !!!
As we recover from the approval in the EU Parliament of the food supplements directive, another - potentially even more dangerous - proposal is taking form in the EU Parliament. It is the planned revision of the EU's medicine laws that apply to the manufacture of pharmaceutical products.
One may ask what this has to do with food supplements or consumer access to them. The response is that proposed changes in the definition of a "medicinal product" are threatening to make any supplement subject to being re-defined "a medicine" at the whim of the EU bureaucracy and their pharmaceutical "advisers" who of course stay well in the background.
Rapporteur has published a timetable for the discussions in the EU Parliament's Environment Committee. The revision will first be taken up on April 21 and 22, then again in May 21, 22, 23 and for a third discussion on June 17 and 18. September will then see the vote of the plenary of the EU Parliament.
This is a tight schedule and if we wish not to lose access to effective health products (which, according to the proposal, are to be re-defined as medicines) we should start acting IMMEDIATELY, contacting Members of the EU Parliament, of the Commission, of national representations to the EU and of the Council of Ministers, pointing out our opposition to the proposal.
The article in Rapporteur has been posted at
where you can also retrieve a pdf file of the proposed changes.
Reading the pdf file you will discover some proposed changes in the definition of a medicine that leave little doubt that the pharmaceutical cartel is using the EU legislative process to try and secure for itself a more than comfortable monopoly on our health.
Pay special attention to the change proposed on
Article 1, Number 2 Medicinal Product and to
Article 2 "The provisions of this directive shall apply to....."
What is proposed in Article 1 will extend the already all-encompassing definition of a medicine to cover potentially any product that claims to have a positive health effect or that has such an effect without even claiming so on the label.
The new text in Article 2 will make it easy to re-classify any natural or nutritional product on the market that has positive properties (either preventive or curative, or even just for "restoring, correcting or modifying physiological functions" into being a medicine, which is a phrase in code for "This product must be taken off the market".
Anyone who supported the food supplements directive should re-think their position in the light of this new proposal, which with one stroke could "empty out" the container of the (already heavily restrictive) food supplements directive, to leave only perfectly useless supplements. Any high dosed, modern formulation, effective nutritional supplement would be subject to "re-classification" as a medicine. This means that a product will either have to undergo (prohibitively expensive) registration as a medicinal product or will vanish from the market.
Most products will vanish, due to two factors:
One: If the manufacturer is a small or medium sized enterprise making food supplements, the costs of registration (and of building an approved pharmaceutical production facility) are simply too high.
Two: If the manufacturer is a large pharmaceutical corporation, there are two principal considerations that will determine whether registration is considered. One is whether the product will sell enough to warrant the expense of registration and the other, even more important consideration is, whether the product will compete with pharmaceutical medicines made by the same company.
The choice between a (non patentable) natural or nutritional product and a profitable pharmaceutical medicine that merely treats the symptoms but leaves the illness intact is a foregone conclusion. Profit may well be the determining factor because the bottom line is of great importance to shareholders and Boards of Directors. A desire to be ethical or to care for people's health comes in second.
Of course we hope that legislators will realise what they are about to sign into law, and turn the tide by limiting, rather than extending, the definition of a medicine. But it is up to us to convince them to do so.