Dear Mr President,
Almost a year has gone in a deafening silence of the authorities in the European Union, in particular, by the European Medicines Agency (EMA), since France suffered from a major health crisis due to the change in LEVOTHYROX formulation manufactured by MERCK.
Article 168(1) TFEU states that a <<high level of human health protection>> shall be ensured in the definition and implementation of all Union policies and activities.
Union action, which shall complement national policies, shall be directed towards <<improving public health, preventing physical and mental illness and diseases, and obviating sources of danger to physical and mental health>>.
Moreover, Article 168(2) TFEU states the <<Union shall encourage cooperation between the Member States in the areas referred to in this Article and, if necessary, lend support to their action>>.
Furthermore, Article 168(4)(c) TFEU provides: By way of derogation from Article 2(5) and Article 6(a) and in accordance with Article 4(2)(k) the European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, shall contribute to the achievement of the objectives referred to in this Article through adopting in order to meet common safety concerns: <<measures setting high standards of quality and safety for medicinal products and devices for medical use>>.
Based on Article 168(7) TFEU that reminds us of the Principle of Subsidiarity in European Union Law, it is the responsibility of the EU to intervene when issues relating to the public health go beyond the narrow framework of a national action. Hence, the EU must respond to a threat generated and funded by a supranational entity that defies the borders and seeks, after all, to satisfy the financial interest of its shareholders put before those who are sick and their families.
To this day, a survey carried out by the Association of VIVRE SANS THYROID by analysing statistical data provided by the Social Security in France has indicated that nearly a million (out of the 3 million patients on LÉVOTHYROX treatment) have been forced to stop the taking the new formula of LEVOTHYROX in order to protect their health (https://www.scribd.com/document/373279023/LEVOTHYROX-Pres-d-un-million-de-Francais-ont-arrete-de-prendre-la-nouvelle-formule ).
We have alarmed the relevant regulatory bodies, including the EMA, in writing on 22 January 2018.
As of now, I still have not received a response.
If this change of formula can cause so many side effects to so many patients in a single country (France), I’m deeply concerned that this health crisis may spread and involve several million patients in Europe.
This is a matter of urgency!
In fact, Merck has announced that they will cease the production of Levothyrox with lactose (old formula) by the end of 2018.
Given the risk taken and the failure of the French Government in facing such a powerful group, it is the duty of the EU to step forward and exercise its authority in order to protect the citizens rather than the financial conglomerates.
On behalf of the thousands of sick French people that I represent, I kindly urge you to intervene promptly in order to protect our citizens, especially, (i) by promoting and maintaining the freedom of choice between the old and the new formula and/or (ii) by demanding clinical tests of the new formula before imposing a <<switch>>, which implies a suspension of all marketing authorizations issued as a precautionary measure.
This letter will be made public on Wednesday 29th March 2018.
I trust that you will give this matter your urgent attention.
Yours sincerely,
Christophe Lèguevaques
Avocat au barreau de Paris
Docteur en droit
Almost a year has gone in a deafening silence of the authorities in the European Union, in particular, by the European Medicines Agency (EMA), since France suffered from a major health crisis due to the change in LEVOTHYROX formulation manufactured by MERCK.
Article 168(1) TFEU states that a <<high level of human health protection>> shall be ensured in the definition and implementation of all Union policies and activities.
Union action, which shall complement national policies, shall be directed towards <<improving public health, preventing physical and mental illness and diseases, and obviating sources of danger to physical and mental health>>.
Moreover, Article 168(2) TFEU states the <<Union shall encourage cooperation between the Member States in the areas referred to in this Article and, if necessary, lend support to their action>>.
Furthermore, Article 168(4)(c) TFEU provides: By way of derogation from Article 2(5) and Article 6(a) and in accordance with Article 4(2)(k) the European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, shall contribute to the achievement of the objectives referred to in this Article through adopting in order to meet common safety concerns: <<measures setting high standards of quality and safety for medicinal products and devices for medical use>>.
Based on Article 168(7) TFEU that reminds us of the Principle of Subsidiarity in European Union Law, it is the responsibility of the EU to intervene when issues relating to the public health go beyond the narrow framework of a national action. Hence, the EU must respond to a threat generated and funded by a supranational entity that defies the borders and seeks, after all, to satisfy the financial interest of its shareholders put before those who are sick and their families.
To this day, a survey carried out by the Association of VIVRE SANS THYROID by analysing statistical data provided by the Social Security in France has indicated that nearly a million (out of the 3 million patients on LÉVOTHYROX treatment) have been forced to stop the taking the new formula of LEVOTHYROX in order to protect their health (https://www.scribd.com/document/373279023/LEVOTHYROX-Pres-d-un-million-de-Francais-ont-arrete-de-prendre-la-nouvelle-formule ).
We have alarmed the relevant regulatory bodies, including the EMA, in writing on 22 January 2018.
As of now, I still have not received a response.
If this change of formula can cause so many side effects to so many patients in a single country (France), I’m deeply concerned that this health crisis may spread and involve several million patients in Europe.
This is a matter of urgency!
In fact, Merck has announced that they will cease the production of Levothyrox with lactose (old formula) by the end of 2018.
Given the risk taken and the failure of the French Government in facing such a powerful group, it is the duty of the EU to step forward and exercise its authority in order to protect the citizens rather than the financial conglomerates.
On behalf of the thousands of sick French people that I represent, I kindly urge you to intervene promptly in order to protect our citizens, especially, (i) by promoting and maintaining the freedom of choice between the old and the new formula and/or (ii) by demanding clinical tests of the new formula before imposing a <<switch>>, which implies a suspension of all marketing authorizations issued as a precautionary measure.
This letter will be made public on Wednesday 29th March 2018.
I trust that you will give this matter your urgent attention.
Yours sincerely,
Christophe Lèguevaques
Avocat au barreau de Paris
Docteur en droit