September 1, 2021
The Sovereignty Act and Medicines
#TheSovereigntyLaw forbids the marketing or use of medicines, vaccines, medical devices and other pharmaceutical products for which the manufacturer offers no guarantees and no demonstrably viable remedies, or for which complete clinical trials have not been carried out; it eliminates advertising for medicines and forbids the offering of advantages (the bribing) of doctors by the manufacturers of medicines:
Article 5
Law 95 of 14 April 2006 on the reform in the field of health, republished, published in the Official Gazette no. 652 of 28 August 2015, as subsequently amended and supplemented, is amended and supplemented as follows:
(1) After article 704, a new article is introduced, art. 704^1, with the following content:
“(1) Medicines or medical devices may not be marketed or used, nor medical treatments applied, for which the manufacturer offers no guarantees and no demonstrably viable remedies against adverse effects.
(2) The marketing or use of medicines, vaccines, medical devices and other pharmaceutical products for which complete clinical studies have not been carried out according to the methodology established by Law is forbidden.”
(2) In article 811, paragraph (1) is amended and shall have the following content:
“(1) For the purposes of the present chapter, advertising for medicines includes any manner of informing through direct contact (the ‘door-to-door’ system), as well as any form of promotion intended to stimulate the prescription, distribution, sale or consumption of medicines; advertising for medicines shall include in particular:
- advertising for medicines addressed to persons qualified to prescribe or distribute medicines;
- visits by medical representatives to persons qualified to prescribe medicines;
- the supply of samples;”
Article 813 is amended and shall have the following content:
“(1) Any form of commercial advertising on television, radio and social networks for authorised or unauthorised medicines, vaccines, medical devices and other pharmaceutical products is forbidden.
(2) The direct distribution of medicines to the population by manufacturers for promotional purposes is forbidden.
Explanatory Memorandum:
Article 5 seeks to defend the state of health of the Romanian people, the holder of national sovereignty; amendments are made to Law 95/2006 on the reform in the field of health, forbidding the marketing or use of medicines, vaccines, medical devices and other pharmaceutical products for which the manufacturer offers no guarantees and no demonstrably viable remedies, or for which complete clinical trials have not been carried out.
Likewise, in paragraph 2 there are repealed 3 sub-points of article 811 of Law 95 of 14 April 2006 which permit certain immoral means of advertising medicines with a direct impact upon the state of health of the Romanian people — a fact which endangers national sovereignty. For this reason, from Article 811 of Law 95 of 14 April 2006 there have also been removed sub-points 5, 6 and 7, reading as follows: “- the stimulation of the prescription or distribution of medicines by offering, promising or granting advantages in money or in kind, except where these are of symbolic value; - the sponsorship of promotional meetings attended by persons qualified to prescribe or distribute medicines; - the sponsorship of scientific congresses attended by persons qualified to prescribe or distribute medicines and, in particular, the payment of the travel and accommodation costs occasioned thereby.”
For the same reasons, in paragraph 3 art. 813 of Law 95/2006 has been amended, forbidding any form of commercial advertising on television, radio and social networks for authorised or unauthorised medicines, vaccines, medical devices and other pharmaceutical products.
For the same considerations, the direct distribution of medicines to the population by manufacturers for promotional purposes has also been forbidden.
TO BE CONTINUED.
Postscript:
If you agree with the principles promoted by the Sovereignty Law, sign up as a volunteer in the #ArmyOfSovereignty at http://VremSuveranitate.ro/ !
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