Affiliations: Chair Jean Monet of EU Law, Granada, Spain. E-mail: jlvalver@ugr.es
Abstract: The trade in illegal pharmaceuticals is a global problem for public health. The transgressions of the rules that govern the distribution and marketing of medicinal products comes in many different forms, including substandard medicines, falsified drugs, counterfeits, ineffective medicines, falsely-labelled medicines and unregistered medicines. All of which breach different provisions of the pharmaceutical legislation and could be appropriately qualified as illegal.
In order to prevent the presence in the market of illegal products is necessary a global approach to define the scope of the problem and the measures to be put in place. It corresponds to the administrative, civil and criminal law to define the different problems and establish the corresponding penalties. Governments on their part should strengthen their controls to detect illegal medicines.
The protection of intellectual property rights is interlinked with the protection from illegal medicines trade and a fundamental issue for the pharmaceutical sector and the patients. If we want better medicines, the patent system is the way to encourage it. An effective intellectual property system provide fair and efficient incentives for innovation. The challenge for governments is to improve the chain of responsibilities to protect the pharmaceuticals market. The improvement of the enforcement of the administrative, civil and penal regulations is imperative.
Keywords: Substandard medicines, falsified drugs, counterfeits, ineffective medicines, falsely-labelled, unregistered medicines, pharmaceutical law, patents, intellectual property rights, EU, Council of Europe, Medicrime Convention, pharmaceuticals inspection, drug distribution
