On 11 December 2017, we reported that Advocate General Bobek had opined in Case C-557/16, Astellas Pharma GmbH, that Concerned Member States (CMS) are co-responsible for marketing authorisations granted under the decentralised procedure (DCP).

This morning, the Court of Justice of the European Union (CJEU) handed down its judgment in the case. The Court ruled that:

  • Article 28 and Article 29(1) of Directive 2001/83/EC (the Directive) must be interpreted as meaning that, in the framework of a DCP for the placing on the market of a generic medicinal product, the competent authority of a CMS cannot itself determine the starting point of the regulatory data protection (RDP) period of the reference medicinal product after the close of the coordinated procedure, and when it adopts its decision on the generic medicinal product in that Member State. However, the CMS is part of the assessment procedure, and must verify the expiry of the RDP period (para 29), or not approve the assessment report (para 30).
  • Article 10 of the Directive, read in conjunction with Article 47 of the Charter of Fundamental Rights of the European Union, must be interpreted as meaning that a court of a CMS involved in a DCP, when faced with an action brought by the holder of the marketing authorisation of the reference medicinal product, against the generic marketing authorisation granted in that Member State, is competent to review the determination of the starting point of the RDP period of the reference medicinal product. On the other hand, that court does not have jurisdiction to determine whether the initial marketing authorisation for the reference medicinal product granted in another Member State was granted in accordance with the Directive.

We will post our analysis of the judgment soon.

In February 2018, the Integrated Research Application System (IRAS) issued revised versions of the template model Clinical Trial Agreement (mCTA) and Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA, used where clinical research organisations undertake site management responsibilities on behalf of the sponsor). The new mCTAs are designed to be used without modification for industry-sponsored trials in the national health service (NHS), and have been updated to reflect current practice and regulations. The new mCTAs should be used from 1 March 2018.

Continue Reading Revised model Clinical Trial Agreements applicable across the UK

The principle of Replacement, Reduction and Refinement of animal testing in the development of medicines (known as the 3Rs) refers to the replacement of animal studies with non-animal methods, the reduction of animal studies, and the refinement of any necessary tests through minimisation of stress of study animals (as illustrated in the graphic below). Under European law, all EU Member States must ensure that the 3Rs are systematically considered whenever animals are used for scientific purposes, including research, regulatory testing and production, education and training (see Directive 2010/63/EC on the protection of animals used for scientific purposes). On 26 February 2018, the European Medicines Agency (EMA) issued a Report summarising its activities during 2016 and 2017 in relation to the 3Rs in the regulatory testing of medicinal products.

Continue Reading EMA issues report on animals used in testing of medicines

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