Medicrime Convention & «Falsified Medicines Directive»

Legislative changes in connection with the implementation of the Medicrime Convention and of the total revision of the Ordinance on Licensing in the Medicinal Products Sector (MPLO) will enter into force on 1 January 2019. This will improve the safety of medicinal products.

At its 14 November 2018 meeting, the Federal Council set 1 January 2019 as the date on which the adjustments to the Swiss Criminal Procedure Code (CrimPC) and the Therapeutic Products Act (TPA) relating to the implementation of the Medicrime Convention will enter into force, with the exception of the new Article 17a of the TPA concerning the voluntary placing of safety features to medicinal product packaging.
The Federal Council also decided that part of the relevant implementing regulations, i.e. the total revision of the Ordinance on Licensing in the Medicinal Products Sector (MPLO), would enter into force on the same date. The dispatch relating to the approval and implementation of the Medicrime Convention had been submitted to Parliament on 22 February 2017, and subsequently adopted as it was by the two chambers of Parliament on 29 September 2017. The legislative amendments will equip Switzerland with the tools necessary to step up the fight against counterfeit medicines, and help enhance the safety of medicinal products in Switzerland.

Implementing regulations: total revision of the MPLO

At its 14 November 2018 meeting, the Federal Council also approved the implementation on 1 January 2019 of the totally revised Ordinance on Licensing in the Medicinal Products Sector (MPLO) and of certain adjustments to the ordinances on medicines (VAM/OMéd/OM) and veterinary medicines (TAMV/OMédV/OMVet). This project of revision also entails certain amendments ensuing from the ordinary revision of the TPA (Stage 2), as well as certain adaptations resulting from new knowledge gained in practice.

Implementing regulations: European “Falsified Medicines Directive”

Besides the legislative changes related to the ratification of the Medicrime Convention, on 29 September 2017 Parliament had also made provision for safety features to be placed to medicinal product packaging (analogous to the features provided for by EU Directive 2011/62/EU “Falsified Medicines Directive”). The implementing provisions relating to the new Art. 17a TPA are being drawn up. Their date of entry into force has not yet been defined, as the deadline of February 2019 is not binding for Switzerland. The consultation procedure is scheduled to take place in winter 2018/2019.

Background and content of the Medicrime Convention

The global trade in counterfeit and illegal therapeutic products is increasing. In its report published in 2006 the WHO disclosed that in the majority of industrialised countries that were equipped with efficient market control systems the proportion of counterfeit medicinal products was less than 1% of the total market. On the other hand, in certain Latin American, Southeast Asian and African countries, the proportion was estimated by the WHO and OECD to be above 30%.

The Medicrime Convention (Council of Europe Convention on the Counterfeiting of Medical Products and Similar Crimes Involving Threats to Public Health) is the first international convention aimed at preventing threats to public health from counterfeit therapeutic products (medicinal products and medical devices). It came into force on 1 January 2016. Switzerland deposited the instruments of ratification on 25 October 2018; the convention will now enter into force on Swiss territory on 1 February 2019.

Legislation

Medicinal products and medical devices legislation

The legislation on therapeutic products comprises the Federal Act on Medicinal Products and Medical Devices (TPA) and the associated ordinances. It is regularly aligned to the state of scientific and technical knowledge.

Last modification 19.11.2018

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Contact

Federal Office of Public Health FOPH
Division of Biomedicine
Therapeutic Products Law Section
Schwarzenburgstrasse 157
3003 Berne
Switzerland
Tel. +41 58 463 51 54
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