European Medicines Verification Organisation (EMVO) update
EMVO maintains a status overview of national stakeholders’ progress, reflecting the countries’ readiness to implement national medicines verification systems and to adopt the blueprint approach. The Progress Monitoring – Monthly Report (PMMR) is used by EMVO to show progress at the national level in terms of stakeholder alignment, MoU development, statutes development and contacts with Blueprint providers.
As of June 2017, EMVO also maintains an overview on the contractual and technical on-boarding, EMVO’s Support KPIs (Key Performance Indicators) and latest news and upcoming projects of the CPM (Commercial & Partner Management) department with the CPM Monthly Report.
You can view the latest version of the PMMR and the CPM in the Member Area / Information for full Members / EMVO at this link.
EMVO recently announced that 22 countries are already connected to the European Hub.
EFPIA & Medicines for Europe FMD implementation workshops
EFPIA and Medicines for Europe, as industry associations, with the participation of EAEPC, GIRP and PGEU, have been organising a number of Falsified Medicines Directive implementation workshops.
The last workshop was held on 13 July 2018 and one of the focus area were the topics of designated wholesalers and the review of Master Data Guide Appendix 5. The next workshop will be held on 11 September 2018.
You can view all documents related to the EFPIA & Medicines for Europe FMD implementation workshops at the following linkunder Member Area / Information for full members / EFPIA & Medicines for Europe FMD implementation workshops.
Publication of Q&A Safety Features for Medicinal Products for Human Use (Version 10)
The European Commission issued the Version 10 of the Q&A documents with the objective to give guidance for the implementation of the FMD and its DR.
The new Q&As do not concern wholesalers directly however, the following questions of direct relevance for our sector have been revised:
- 3.5 concerns the reversion of decommissioning for products exports outside of the EU (once decommissioned the pack cannot be recommissioned by a wholesaler)
- 5.5 refers to wholesalers selling products outside the EU without products physically leaving EU territory (no decommissioning)
- 6.6 gives guidance for holders of a wholesale distribution authorisation who intend to facilitate the decommissioning of products for hospitals
Article 81 (2) of Directive 2001/83/EC - Questionnaire outcome
At the end of last year, the European Commission launched a questionnaire to gather the views of the Member States on the implementation of Article 81 (2) of Directive 2001/83/EC. On 25 June 2018, the European Commission published the feedbacks collected from this questionnaire.
Responses have been received from 27 Members States. A paper on the obligation of continuous supply to tackle the problem of shortages of medicines has also been published.
More information is available here.
A European retail sector fit for the 21stcentury - Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of Regions
On 19 April 2018, the European Commission published the communication "A European retail sector fit for the 21st century - Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of Regions". The communication follows the launch of a public consultation in July 2017, "Retail regulations in a multi-channel environment", and to which GIRP had submitted a reply.
The European Commission's stated objective is to help Member States and operators overcome the current challenges by addressing an accumulation of restrictions in the retail sector. The European Commission believes it has identified very concrete and effective best practices to guide Member States' efforts in increasing the innovation, productivity and competitiveness of the European retail sector and that it can help Member States to follow the example of tried-and-tested reforms in other EU countries. The will be done mainly during the European semester.
In the context of the release of this communication, GIRP had a meeting, on 18 April, with the Head of Unit responsible for this dossier in the European Commission and was informed that the European Commission will be holding a conference to communicate directly with stakeholders on the communication on the 19th of June 2018 in Brussels. During the meeting it was underlined that the communication is seeking to strike a balance between traditional retail establishments and online retailing. The Commission representatives were eager to point out that the communication does not address in any way pharmacy ownership but rather references issues related to both establishment and operational restrictions in the retail sector as a whole. Specific references are made to Member State practices in relation to the sale of OTC medicines. More information on the Communication is available here.
GIRP also attended the event “European Retail Sector Fit for the 21stCentury”held under the “Single Market Forum” umbrella on 19thJune in Brussels.
The Conference was organised by Mr. Hubert Gambs – Director, DG GROW with key-not speeches from Elżbieta Bieńkowska, Commissioner for Internal Market, Industry, Entrepreneurship and SMEs and Kris Peeters, Deputy Prime Minister and Minister of Employment, Economy and Consumer Affairs of Belgium, in charge of Foreign Trade and a closing speech by Jyrki Katainen, Vice-President of the European Commission. The conference was focused on boosting the retail sector in Europe by combining digital sales with brick and mortar retail outlets. Europe’s retail sector is losing competitiveness due to operational restrictions such as limited opening hours, restricted possibility for sales and restrictions for establishment of new shops, whereas online sales are fast growing. It was stated that the perfect blend between online sales and physical shops has to be found.
The idea of liberalising the sale of OTC medicines was only raised during one panel by Ms. Anu Raijas, Competition and Consumer Authority of Finland who stated that Finland has a project to allow OTC medicines sales outside of pharmacies and by Mr. Franck Geretzhuber, Secretary General of Auchan Retail who stated that there is no reason why products for self-medication should not be sold outside oh pharmacies, especially in the light that most recalled products are found on pharmacies’ shelves! The statements were strongly contradicted by GIRP. GIRP also used the opportunity to send its paper on “Access to non-prescription medicines – the key role of pharmacy in health-care” as feed-back to the Commission.
European Commission’s eHealth Strategy
On 25 April 2018, the European Commission adopted a plan of action to enable the digital transformation of health and care in the Digital Single Market, intended to put citizens at the center of the healthcare system.
The key identified elements are:
1. Citizens’ secure access to and sharing of health data development and adoption of a “European electronic health record exchange format”, establishment of interoperable standards that would minimise barriers to cross-border transfers
2. Better data to promote research, disease prevention and personalised health and care, set up a mechanism for the voluntary coordination of authorities and other stakeholders to share genomics and other health data; support the development of common technical standards for the exchange of information for research and public health purposes; demonstrate the benefits of data-pooling by launching pilot schemes that will coordinate relevant programmes, initiatives and actors at both a national and EU level.
3. Digital tools for citizen empowerment and for person-centred care; support cooperation to stimulate the supply and uptake of digital health, by promoting common principles; support the exchange of innovative and best practices; capacity building and technical assistance for health and care authorities; support investment by EU Member States and regions in large-scale deployment of digitally-enabled, integrated, person-centred care; raise awareness of innovative procurement and investment possibilities.
Funding will come from Horizon 2020, Connecting Europe Facility and third “Health” programmes, with further funding to be considered under the next EU multi-annual financial framework.
The Commission explicitly notes that data protection principles are core elements of the proposals in the Communication and that compliance with EU data protection rules are “essential” to achieve the goals stated in the Communication.
Council of the European Union
The Austrian Presidency of the Council of the European Union
From 1 July to 31 December 2018, Austria is holding the six-month rotating presidency of the Council of the European Union (EU) for the third time since its accession to the EU. This time around, the Austrian Presidency will come during a crucial moment for the EU, with a European election less than a year away and the negotiations on the withdrawal of the United Kingdom needing to be finalised by the end of its term.
The Austrian Presidency’s work in the health policy field builds upon the areas that have been covered by the Bulgarian Presidency during the last months to adopt Council Conclusions to strengthen the EU cooperation on vaccine-preventable diseases, to advance on pharmaceutical policies, to address tensions over Health Technology Assessment (HTA), and to present an EU common position on the World Health Organization’s Framework Convention on Tobacco Control (WHO FCTC).
Along these priorities, a new legislative dossier has been added to the health portfolio, following the Commission’s release in May of a proposal on a manufacturing waiver to the supplementary protection certificate (SPC).
The Austrian Presidency also aims to enhance collaboration between Member States and address current challenges in access to medicines by making progress on proposals for voluntary cooperation on pricing and reimbursement of medicines and joint procurement. One of the stated priorities is to discuss and identify the current regulatory bottlenecks of the European centralised authorisation of medicines that hinder the supply of drugs and access to innovation in all European markets, in order to “tackle policy failures within the pharmaceutical sector”.
More information available here.
Proportionality test for new national regulations for professions
In January 2017, the European Commission published a “Proposal for a regulation of the European Parliament and the Council introducing a proportionality test before adoption of new regulation of professions”, as part of the roadmap laid out in the Single Market Strategy.
The scope of the directive is to create a legal framework for conducting proportionality assessments before introducing new or modifying existing legislative, regulatory or administrative provisions restricting access to or pursuit of regulated professions.
Member States would have an obligation to conduct an ex-ante proportionality assessment, substantiated by qualitative and, wherever possible, quantitative evidence before introducing new or modifying existing provisions restricting access to or pursuit of regulated professions. The proposal sets out the main criteria, which have to be considered by the competent authorities, such as the nature of the risks, the scope of the activities, reserved to a profession, the link between the qualification and the activities, or the economic impact of the measure. It also underlines the obligation to inform all interested parties before introducing new measures and give them the possibility to express their views, as well as the mandatory exchange of information between competent authorities of different Member States, allowing the Member State which intends to reform a profession to gather the information on the experience of other Member States.
On 30 April 2018, the EU's committee of permanent representatives (Coreper) endorsed the agreement between the Bulgarian presidency of the Council and European Parliament negotiators. The final text of the directive recognises the special nature of health professions and ensures a sufficient margin of discretion to Member States to guarantee the highest level of human health protection when regulating health professions.The compromise text was adopted by the European Parliament on 14 June 2018.
More information available here.
Proposal for a regulation on veterinary medicinal products
On 20 December 2017, EU ambassadors (Coreper) agreed on the Council position, clearing the way for starting the Trilogues. A provisional agreement was reached at the sixth trilogue held on 5 June, and the Coreper confirmed the final compromise text on 13 June 2018.
The European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) approved the agreement on 20 June, and a Plenary vote is planned for October. The final adoption of the regulation by the Council is expected before the end of the year.
More information is available here.
Financing integrated care and health population management
How to mobilise investments for large scale deployment of integrated care and population health management was a key topic discussed at the event on 22 May 2018 leading to the ICIC18 (18th International Conference on Integrated Care). Integrated care models create a more coordinated form of care provision, moving away from its focus on the hospital and relocating healthcare closer to the patient (preventative approach). For healthcare distributors, these reforms would mean a reduction of volumes and transactions through de-medicalisation and de-hospitalisation processes, and growing opportunities with regards to value-added services.
More information available here.