The Finnish government has through a recent Government Bill (HE 183/2013 the “Bill”) proposed to amend the Medicines Act (395/1987) in accordance with Directive 2011/62/EU (amending Directive 2001/83/EC) on preventing entry of falsified medicinal products into the legal supply chain.
The Bill proposes several amendments, which aim to hinder counterfeit medicines from entering into the legal medicines supply chain and to ensure good manufacturing practice (GMP). When ingredients intended to be used in medicines for humans are imported to the EEA from third countries, a written authority statement on the GMP requirements and supervision of the country of export is required. The supervision of the supply chain from manufacturer to consumer is extended to cover also suppliers of medicines. The suppliers are to register with the Finnish Medicines Agency (FIMEA) and to comply with good supply practice. Further, the amended Act imposes an obligation to the actors on the pharmaceutical sector to inform authorities of suspected counterfeit products.
In addition, the Bill mentions the working group set up by the Ministry of Justice, which worked on a proposal to make Finnish legislation compatible with the Council of Europe’s Convention on the counterfeiting of medical products and similar crimes involving threats to public health (CETS No. 211). Ms Johanna Lilja, Partner at Roschier, was also a member of this working group.