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

A quick note to inform you that the EMA launched its new improved version of the Eudravigilance system on 22 November 2017. It is now mandatory to report suspected ADRs through the new system.

The new system has been designed to offer “enhanced features for the reporting and analysis of suspected adverse reactions, to support stronger safety monitoring of medicines and a more efficient reporting process for stakeholders”. It will be interesting to monitor whether the system delivers these improvements, as time passes, and users become more familiar with it.

For further information, please refer to our previous blog and the attached guidance.

The Competent Authorities for Medical Devices (CAMD) was established to enhance collaborative working, communication and surveillance of medical devices across Europe. With the introduction of the Medical Devices Regulations (the MDR and IVDR), two groups were set up within the CAMD: (i) the Transition Subgroup, which will develop guidelines on the application of the MDR/IVDR during the transitional period, and details of which aspects of the Regulations devices will have to meet to be placed on the market during this time, and (ii) the Implementation Taskforce to facilitate collaboration and cooperation during the implementation phase of the new Regulations.

Earlier this month, the Implementation Taskforce published a high-level MDR/IVDR Roadmap. The Roadmap is the first glimpse into the intentions of the Commission and authorities across the EU as to how the Regulations will be implemented, and the order in which key guidance and clarification will be developed.

Continue Reading Roadmap on MDR/IVDR published

The awaited decision of the EU Member States on the new home for the European Medicines Agency (EMA) was published today. The final destination, Amsterdam, does not come as a complete surprise, despite the fact that the key institutions involved in the process, the Commission, the EMA and the Council, have consistently avoided naming preferred locations. As of today, the EMA has 17 months to conclude its move and take up its operations from Amsterdam by the end of March 2019.

The decision to relocate the EMA, although a consequence of the UK’s decision to leave the EU, does not form part of the Brexit negotiations. The procedure leading up to a decision on the relocation of the EMA was proposed by the Presidents of the Commission and the Council and was endorsed at the European Council meeting of 22 June 2017. Member States had up to the end of July 2017 to submit their offers to host the Agency.  Nineteen Member States put in bids.

Continue Reading EMA’s New Home

The European Commission has finally published the draft amendment to Regulation No 847/2000 regarding the concept of “similar medicinal product” for the purposes of the Orphan Medicinal Products Regulation. A key incentive of this Regulation is the ten-year market exclusivity that protects an orphan medicinal product, whereby national competent authorities shall not accept an application for authorisation, or grant an authorisation, or accept an application to extend an existing authorisation, “for the same therapeutic indication, in respect of a similar medicinal product” as the orphan product. Regulation 847/2000 defines “similar medicinal product” in this context, and sets out a number of examples of what kind of products will be similar.

Following a consultation last year, the Commission intends to make changes to the 17-year-old text to account for the rise of cell therapies and other advanced therapy medicinal products, the nature of which do not fit neatly into the current definitions.

Continue Reading Draft Regulation amending definition of “similar medicinal product”