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26 November 2014
Europe recently adopted new instruments to combat the cross-border phenomenon of falsified medicines. According to specialised studies, the falsification of medicines has increased significantly as a result of the growing trend of commercialising medicines online.
At an EU level, the EU Falsified Medicines Directive (2011/62/EU) came into force on January 1 2013 and introduced measures which aim to protect patients by preventing falsified medicines from entering the legal supply chain.
The European Council has proposed an instrument which focuses on the prosecution of criminal behaviour in the counterfeit medicines field and contemplates international cooperation measures to achieve this objective. This instrument – the Council of Europe Convention on the Counterfeiting of Medical Products and Similar Crimes Involving Threats to Public Health (the Medicrime Convention) – was signed on October 28 2011 by 11 countries, including Switzerland.
Switzerland has taken efficient measures to counter illicit imports of medicines and a significant reduction in such activity was noted between 2010 and 2012. According to the Agency for Therapeutic Products (Swissmedic), the reduction was due largely to awareness campaigns and criminal proceedings.
However, Switzerland is willing to increase its activity in this area and may implement the Medicrime Convention into Swiss law, as well as considering the potential implications of the Falsified Medicines Directive for Switzerland.
The question arises as to whether these instruments might have a significant effect on existing Swiss legislation on protection against falsified medicines and, if so, what the expected changes and their consequences may be.
The Medicrime Convention has been ratified by three countries (Ukraine, Spain and Hungary). It will come into force once it has been ratified by five countries, including three EU member states.
Switzerland is also contemplating ratifying the convention. After detailed analysis, the Federal Council concluded that although existing legislation complies to a great extent with the contents of the convention, its implementation into Swiss law would require a few amendments to the Federal Act on Medicinal Products and Medical Devices (December 5 2000) (Therapeutic Products Act) and the Criminal Procedure Code.
Supplementation of 'distribution' in Therapeutic Products Act
The convention provides that, when committed intentionally, the following should be established as offences:
Since the term 'distribution', as defined in Article 4 of the act, contemplates only the transfer and release of therapeutic products, the Federal Council deems it appropriate to supplement this definition by expressly including brokering activities and to subject such activities to wholesale business authorisations.
Although Switzerland is not bound by European law, this will further comply with the Falsified Medicines Directive, which includes brokers in the list of persons that are subject to wholesale distribution authorisations.
According to the Federal Council, since brokers do not play a significant role in the medicine supply chain in Switzerland, this amendment will have only a limited effect.
Designation of Swissmedic as single point of contact
The convention provides for the designation of a single point of contact in order to facilitate the exchange and coordination of information relating to counterfeit medicines at national and international level. As Swissmedic fulfils this role within the single point of contact system developed by the European Council, proposed integration into the act would merely further formalise its existing role (proposed new Article 69(4)).
Information exchange between competent authorities and commercial and industrial sectors
The convention requires that parties to the convention take necessary measures to ensure that the competent authorities (including health authorities, Customs and police) exchange information and cooperate with a view to combating effectively the counterfeiting of medicines.
In order to comply, the Federal Council proposes to modify the Therapeutic Products Act by:
Measures for secret control of post, telecommunications and secret investigations
The convention provides that parties must take necessary measures to ensure effective criminal investigation and prosecution of counterfeiting medicines and similar offences, allowing the competent authorities to conduct financial investigations, covert operations, controlled delivery and other special investigative techniques where appropriate.
For that purpose, the Federal Council has proposed to supplement the Therapeutic Products Act and the Criminal Procedure Code with a view to aligning their provisions on existing measures in respect of drug offences.
It has thus proposed:
Option to transfer criminal proceedings to Office of Attorney General
Under existing Swiss legislation, when criminal proceedings relating to medicines fall within the jurisdiction of both the cantons and the Confederation, the Confederation has the power to delegate prosecution of the offence to the relevant canton.
The Federal Council proposes to allow delegation of competence in the opposite way, in order to combat certain offences (the illicit import of medicines to Switzerland), with a view to re-distributing them abroad and/or in Switzerland (proposed new Article 90(3) of the act).
The council also proposes to allow delegation to the federal level of criminal proceedings pursued by Swissmedic or the Swiss Customs Administration where such proceedings relate to offences committed abroad or are highly complex (proposed new Article 90(b)).
Lighter measures for secret control
In order to strengthen the powers of Swissmedic and Customs, the council has proposed to establish in the act a legal basis on which these authorities could impose light control measures – for example, the secret observation of persons and objects in free access places or fictional purchases of illicit medicines. If more serious measures are required or necessitate international collaboration, the proposed amendment contemplates the transfer of the proceedings to the attorney general of Switzerland (proposed new Article 90a).
The council submitted the project for ratification and implementation of the Medicrime Convention to a consultation procedure involving the cantons, political parties, municipality associations, national economic associations and relevant sector organisations. The consultation procedure started in December 2013 and ended in April 2014. The council is now expected to issue a report on the results of the consultation.
The Falsified Medicines Directive mainly provides for:
In response to concerns regarding the directive's impact on pharmaceutical production and safe supply of medicines in Switzerland, the council has advised the following:
In Switzerland, private individuals are authorised to import medicines which are neither authorised nor subject to marketing authorisation, as long as these are imported in small quantities.
Following certain motions, the council decided to consult with the relevant organisations on whether this authorisation should be maintained, together with the question of the approval of the Medicrime Convention and its implementation into Swiss law.
The issue appears controversial as it affects private individuals' right to access medicines, including in sensitive situations where individuals are based in Switzerland only temporarily and may need specific medicines which are not commercialised in Switzerland. It also raises issues in terms of the further logistical burden that a ban on the import of unauthorised medicines would impose on the Swiss Customs Administration.
Since Switzerland is well equipped to combat the counterfeiting of medicines and Swiss legislation meets most of the requirements set forth in the European instruments, no major changes should be expected in the coming years. However, the council will still issue a report on the approval and implementation of the Medicrime Convention, as well as the issue of the importation of unauthorised medicines by private individuals. This may give rise to interesting developments which should be carefully monitored.
For further information on this topic please contact Laurence Ponty or Georges Racine by telephone (+41 22 319 87 00), fax (+41 22 319 87 60) or email (email@example.com or firstname.lastname@example.org). The Lalive website can be accessed at www.lalive.ch.
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