Abstract
Because the falsification of medicines is a global problem, requires increased and effective international coordination and cooperation to ensure the effectiveness of the strategies to combat counterfeiting, especially in relation to the sale of such products on the Internet. In the context of people’s health and life rank foremost among the values and interests protected by the TFEU, this article examines the evolution of the legislative process regulating the internal market for medicinal products in order to ensure a high level of protection of public health against falsified medicines and to present the legislative initiatives that have been taken at EU level taking account of new risk profiles, measures meant to ensure, at the same time, the functioning of the internal market of medicinal products. However, this article aims to address consumers’ right to have access to safe, effective, quality and innovative medicinal products as a right of the European patient. Ensuring the free movement of medicinal products on the EU market must not violate or restrict this fundamental right of thepatient.The threat that falsified medicines pose to public health is also recognized by the World Health Organization (WHO), which has established the International Medical Products Anti-Counterfeiting Taskforce ("IMPACT").IMPACT has developed the Principles and Elements for National Legislation against Counterfeit Medical Products, which were endorsed by the IMPACT General Meeting in Lisbon on 12 December 2007.
Highlights
To reduce the disparities in the field of medicinal products for human use, between certain national provisions, which directly affected the functioning of the internal market, was necessary to draw near the relevant laws, establishing rules for monitoring medicinal products and specifying the obligations of the competent authorities of the Member States to ensure compliance with the legal requirements
When referring to the implications of a falsification of on public health, we must consider both the specific characteristics of the products in question, and the severity of the conditions intended to be treated with such medicinal products
Another aspect to be taken into consideration when introducing counterfeit medicines into the legal distribution chain is the price of counterfeit medicines
Summary
To reduce the disparities in the field of medicinal products for human use, between certain national provisions, which directly affected the functioning of the internal market, was necessary to draw near the relevant laws, establishing rules for monitoring medicinal products and specifying the obligations of the competent authorities of the Member States to ensure compliance with the legal requirements.Considering its importance for health services, the pharmaceutical sector is subject to strict regulations. The main objective of rules governing the production, distribution and use of medicinal products must be to safeguard public health, the means by which this goal is achieved, should not prevent the development of the pharmaceutical industry or of the trade in medicinal products in the European Union. In this context, the existing regulatory framework in this sector should not include unnecessary regulatory constraints that restrict and limit competition.
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