Article 118a of Directive 2001/83/EC requires Member States to lay down “effective, proportionate and dissuasive” penalties for those who are involved in the manufacturing, distribution, brokering, import and export of falsified medicinal products. On 26 January 2018, the European Commission published a report on how this requirement has been met by individual Member States, based on a detailed study performed by external contractors, empirica and  ZEIS, on behalf of the DG for Health and Food Safety.

The report indicated that 26 Member States had amended their legislation to accommodate new penalties for the falsification of medicinal products. The exceptions were Hungary, which changed its Criminal Code as a result of the Council of Europe Medicrime Convention, and Finland, which already had penalties in place before Article 118a took effect.

In 21 Member States, the manufacturing, distribution, brokering, import and export of falsified medicinal products attracts criminal penalties. In the remaining Member States (Bulgaria, Finland, Latvia, Romania, Poland, Sweden and Lithuania) only certain infringements are considered criminal.

Continue Reading Commission Survey on National Penalties for Breach of Falsified Medicines Rules in EU Member States

Software can be considered a medical device under EU law. Although guidance has been issued by the European Commission and national authorities to assist in legal classification, factors or criteria that are considered as relevant in such guidance have not been validated by European or national courts. The recent decision of the Court of Justice of the European Union (CJEU) on legal classification of software medical device is therefore instructive.

The European Court’s first decision on the classification of software in the context of medical devices legislation

On 7 December 2017, the CJEU issued its judgment in Case C-329/16. The CJEU agreed with the Advocate General’s opinion (discussed in our previous advisory), and held that software can be classified as a medical device under EU law if the software has at least one functionality that allows the use of patient-specific data to assist the physician in prescribing or calculating the dosage for treating the underlying condition. It does not matter whether the software acts directly or indirectly on the human body. The decisive factor is whether the software is specifically intended by the manufacturer to be used for one or more medical objectives specified in Article 1(2) of Directive 93/42/EEC (the Medical Devices Directive), including the diagnosis, prevention, monitoring, treatment or alleviation of disease.

Continue Reading Classification of software as a medical device

Join us for a complimentary medical devices bootcamp aimed at junior lawyers and new joiners in the medical devices and life sciences sectors

During this full-day seminar we will provide a comprehensive introduction to the regulation of medical devices  including changes introduced by the new medical devices and in vitro diagnostic Regulations, and what this means for your organisation. We will also be joined by guest speaker Graeme Tunbridge from the MHRA who will talk the audience through the role of the Regulatory Authority.

Topics include:

  • Definition and life cycle of a medical device
  • Introduction to the relevant legislation- including changes under the MDR/IVDR
  • Classification of a medical device
  • Conformity assessment procedure
  • Clinical investigations
  • Post-authorisation obligations
  • Promotion and market access
  • Companion diagnostics
  • Liability issues

The full agenda and link to RSVP can be found on the website. Hope to see you there!

At the end of December, a new version of Chapter 1 of Volume 2A of the Notice to Applicants was published by the Commission. The Notice to Applicants is prepared by the European Commission, in consultation with the competent authorities of the Member States and the EMA, and sets out guidance on the interpretation of the EU legislation. The recent update does not introduce wholesale changes, but there are a few interesting additions:

Continue Reading New NTA published

Following the implementation of the new EudraVigilance system, reported in our previous post, and in an attempt to streamline the monitoring of safety signals in EudraVigilance, the European Medicines Agency (EMA) has recently announced that the marketing authorisation holders (MAHs) of 300 specific active substances and combinations of active substances will be required continuously to monitor activities in relation to their substances in EudraVigilance. The scheme will begin on 22 February 2018 and will last one year. During the pilot period, the affected MAHs will be required to inform the EMA and national competent authorities of validated safety signals relating to their medicines. MAHs who are included in the pilot scheme should refer to the guidance contained in the Good Pharmacovigilance Practices (GVP) Module IX – Signal Management in relation to the monitoring and reporting of safety signals. MAHs who are not part of the pilot scheme will not be required to monitor EudraVigilance or to inform the regulatory authorities of validated signals while the scheme is in operation. However, they will have access to EudraVigilance data and will be able to incorporate any relevant new safety data into their own safety monitoring systems. The EMA will use the experience gained during the pilot period to improve the next phase of safety signal detection.

Continue Reading EudraVigilance—safety signals pilot scheme

On 20 December 2017, the Court of Justice of the European Union (CJEU) confirmed that the term of a supplementary protection certificate (SPC) can be corrected to bring it into line with CJEU case law at any time before expiry of the SPC.

Following on from the decision in Seattle Genetics (C‑471/14) in 2015, which provided welcome clarity on which date should be used as the date of the first marketing authorisation (MA) for the purposes of calculating the duration of an SPC, this week’s decision should drive consistency in the application of Seattle Genetics by national patent offices across the EU. In Incyte (C‑492/16), the CJEU has ruled that an SPC holder can apply to rectify the duration of an SPC to bring it into line with Seattle Genetics at any time before expiry of the SPC, even if the period for appealing the decision under national legislation has passed.

Continue Reading CJEU confirms that SPC term calculated using “incorrect” MA date can be rectified at any time before expiry

In October, we reported that the oral hearing before the Court of Justice of the European Union (CJEU) took place in Case C-557/16 relating to the role of the Concerned Member States (CMS) in the Decentralised Procedure (DCP).

The Opinion of Advocate General Bobek has now been handed down. Although the AG takes no position on whether Ribomustin or Levact should have been used as the reference medicinal product, or when the applicable regulatory data protection (RDP) period started running, he opines that the CMS may raise issues as to RDP during the assessment phase and are co-responsible for the documents approved in that procedure. However, once agreement has been reached, CMSs cannot unilaterally revisit that decision. After authorisation, the courts of CMSs are competent to review the determination of the national competent authority.

Continue Reading AG opines that CMSs are co-responsible for MAs granted under the DCP

On 5 December 2017, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a Post-implementation Review of the Human Medicines Regulations 2012 (the Review). The Review assesses the effectiveness and impact of the Human Medicines Regulation 2012 (the 2012 Regulations), which were introduced in the UK with a view to implementing a series of EU directives and to consolidate UK medicines legislation. The Review also sets out recommendations about how to address shortcomings identified in the 2012 Regulations.

Based on the Review, the 2012 Regulations are to be retained and it seems that no major overhaul of these Regulations is to be expected. However, there are likely to be several pieces of guidance issued by the MHRA in the near future in relation to those aspects of the 2012 Regulations that have proved most controversial (e.g., on cross-border prescriptions and wholesale dealing). It is hoped that these will provide welcome clarification. In addition, measures intended to ease the burden for manufacturers of generic medicinal products in relation to the maintenance and distribution of Risk Management Plans and Risk Minimisation Measures may be introduced shortly. The suggestion made by the MHRA in the Review is that work-sharing should be “encouraged” as between marketing authorisation holders, although some respondents to the consultation have suggested that work-sharing should be mandatory. It remains to be seen how, and in what form, the MHRA chooses to introduce any such new measures.

Our advisory, discussing this further, can be found here.

On 21 September 2017, Advocate General Saugmandsgaard Øe delivered his Opinion in Case C-179/16 Hoffmann-La Roche, finding that licensed and unlicensed medicinal products used for the same indication may fall within the same relevant product market.

Background

Genentech’s drugs Avastin (which is licensed to Roche) and Lucentis (licensed to Novartis) are based on different active substances but are derived from the same antibody and have similar mechanisms of action. Avastin obtained marketing authorisation first, for treatment of certain types of cancer and Lucentis later obtained marketing authorisation for treatment of certain ophthalmologic conditions. However, during the interval between grant of the two marketing authorisations, a number of medical practitioners used Avastin in smaller doses to treat ophthalmologic conditions. Furthermore some practitioners have continued to use Avastin even after grant of marketing authorisation for Lucentis because of the substantially lower treatment cost of Avastin.

Continue Reading Hoffman-La Roche – AG finds unlicensed use should be included in relevant product market

On 22 November 2017, the European Commission adopted new guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products (ATMPs). ATMP manufacturers must ensure compliance with these guidelines no later than 22 May 2018.

The guidelines seek to reflect the rapid technological and medical advancements being made in the field of ATMPs (i.e. gene therapies, somatic cell therapies and tissue engineered products), such as decentralised manufacturing for autologous products, automated production, outsourced reconstitution, and gene editing technologies such as CRISPR and immunomodulators. Currently, these new technologies must comply with the general GMP guidelines set out in Volume 4 of The rules governing medicinal products in the European Union. However, these products are often developed in an academic or hospital setting under quality systems different to those typically required for the manufacture of conventional medicinal products.

Continue Reading New guidelines on GMP for Advanced Therapy Medicinal Products