GIRP EU Brief - December 2017

GIRP - EU Brief - December 2017 - Issue V


EU Brief - December 2017 - Issue V


Dear Members,

We would like to take this occasion to thank you all for your goodwill and collaboration throughout the past year, and to wish you a very happy holiday season!

We look forward to our continued cooperation in the coming year. Our best wishes for 2018!


Monika Derecque-Pois
Director General

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.

GIRP/PGEU End-Users Workshop

On 25 October 2017, GIRP and PGEU held the first End-Users Workshop in order to discuss the architecture of the end-user IDs in the blueprint system as well as technical details related to the end-user connection to the system.

Letter of announcement – On-Boarding fee

EMVO announced on 15 December 2017 that as of the 15 of January 2018, the On-boarding fee (for manufacturers) will rise by 50% of the current amount. At present, EMVO counts a small number of OBPs (on-boarding partners), and the rise of the on-boarding fee aims to mitigate the increasing support costs due to the high number of on-boarding connection expected as late followers.

More information is available in the Member Area / Information for full Members / EMVO at this link.

EMVO – New release of the On-Boarding Partner Portal

In October 2017, new features on the OBP (On-Boarding Partner) portal has been released, in order to accelerate the on-boarding process for all OBPs.

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 29 November 2017 and focused on technical and legal aspects of the system, as well as on data access by NCAs. The next workshop will be held on 18 January 2018 in Brussels. A series of workshops is planed for 2018.

EMVO – Estonia Presidency Conference

EMVO, supported by GIRP and the other EMVO members, organised a conference in Tallinn/Estonia, on 8 and 9 November 2017. The conference welcomed representatives of the European Commission and stakeholders. During the conference it was pointed out that this is a Pan-European project and strong involvement and cooperation of all supply chain stakeholders on European and national level is needed.

Different stakeholders brought out their main challenges. GIRP pointed out that the consolidated data on wholesalers’ distribution authorization holders is lacking in EU and it is difficult to find out which organisations have to be connected to the repository system.

The conclusion of the conference was that Europe can be ready to implement the safety features thanks to all stakeholders’ strong commitment and efforts.

Presentations from the conference are available at this link.

NCAs access to data

The NCAs have been reflecting on their rights (Article 39 of the Delegated Regulation) to access and use data in the national medicines verification repositories. They have developed 4 living position papers presenting their expectations on the access and use of data have been updated.

Furthermore, EMVO has been developing an overview of possible reports. Negotiations on data access by NCAs are ongoing. A next meeting is planned in January 2018.

You can access the latest version of the documents in the Member Area / Information for full members / EMVO / NCAs access to data, following this link.

European Commission letter to European stakeholder associations on the timely implementation of safety features

The European Commission addressed a letter to the European stakeholder associations concerning a call from to accelerate joint efforts to ensure the timely implantation of the safety features across Europe. While acknowledging the hard work and success achieved thus far, in the above-mentioned letter the European Commission is calling for an acceleration in the pace of efforts to ensure systems are ready and end-users are in a position to comply with their respective regulatory obligations on time.

You can access the letter in the Member Area / Information for full members / EMVO following this link


GIRP Autumn Conference 2017

On November 22, GIRP held its annual Autumn Conference in Brussels. The event focused on "Supply Chain Opportunities Beyond Delegated Regulation Compliance" and paved the way for GIRP members to be updated on the newest developments throughout the pharmaceutical supply chain, having facilitated their engagement in open discussions and exchange of standpoints.

The discussion touched upon several aspects of vital importance to the continuous improvement sought by healthcare distribution stakeholders.

On the same day, GIRP was delighted to hold its annual European Parliament Reception, kindly hosted by Ms Karin Kadenbach (MEP). Given the great participation, GIRP members had the opportunity to engage in discussions on current relevant issues with MEPs of the ENVI (Environment, Public Health and Food Safety) Committee, representatives of the European Commission and Health Attachés.

All in all, GIRP is proud to announce the outstanding success of this year's Autumn Conference, all the while expressing deep gratitude to the distinguished speakers who accepted our invitation and delivered the highest quality material, our participants for joining us and our sponsors for their valuable and continuous support.

Discussion on the first UDI related guidance under the new Medical Devices regulations

On Friday, 8 December 2017, GIRP took part to the meeting of the UDI working group established by the European Commission.

The work on the basic UDI-DI (Unique Device Identifier) has started, and its specifications are not particular critical for healthcare distributors. The Basic UDI-DI does not appear on any trade item. Its main keys are stored in the database to identify a device with the same attributes and essential characteristics.

A UDI-DI shall be associated with one and only one Basic UDI-DI. The Basic UDI-DI shall be unique for the devices (group) covered by the UDI-DI.

GIRP will have a meeting with the European Commission on Medical Devices in January.

GIRP will continue to participate to this working group and keep its members informed on further developments.

Corrigendum to the two Medical Devices Regulations

By the end of the year, the European Commission will launch a process to adopt a corrigendum to the Medical Devices and in-vitro diagnostic Medical Devices Regulations. The objective of the corrigendum is to correct those mistakes contained in the two Regulations, having pure editorial nature.

In this respect, the European Commission has welcomed contributions and support as well as reports identifying editorial mistakes (both in the English and in the translated versions of the two texts).

GIRP will keep its members informed on further developments.

Free flow of non-personal data

The European Commission has proposed a Regulation aiming at removing obstacles to the free movement of non-personal data.

On personal data, as well as ensuring a high level of protection for personal data, the General Data Protection Regulation (GDPR) already provides for the free movement of personal data within the Union. Together with the GDPR, this Regulation will therefore ensure a comprehensive and coherent approach to the free movement of data in the EU.

The new Regulation will ensure free movement of non-personal data across borders, the availability of data for regulatory control, easier switching of cloud service providers for professional users.

Follow this link to access the text of proposal for a regulation on the free flow of non-personal data. It will work its way through the legislative machinery. GIRP will monitor and report accordingly. 

Health spending priorities for 2018

The European Commission will spend €62 million in health money next year on three priorities: the European Reference Networks for rare diseases; health promotion and prevention of chronic and major diseases; and getting ready to respond to any serious cross-border health threats, according to the work program adopted today.

The European Commission will also allocate some 7 percent of next year’s health budget on the implementation of EU laws on medical devices.

The EU Health Program has a €450 million budget over seven years, which will be spent on four objectives, by 2020: promoting health and preventing diseases; protecting citizens from cross-border health threats; supporting public health capacity building and contributing to sustainable health systems; and facilitating access to better and safer health care for EU citizens.

You can access the European Commission work program at this link

European Commission launches public consultation on vaccines

On 17 December 2017, the European Commission opened a public consultation on its vaccines initiative. Earlier this month, the European Commission had published its strategy for developing a Council recommendation on improving vaccine cooperation around the EU — a priority project for Commission President Jean-Claude Juncker.

More information of the European Commission strategy is available at this link.

To access the pubic consultation, click here.

Proportionality Test Directive – European Parliament's Committee on Environment, Public Health and Food Safety (ENVI) draft opinion

The Commission plans to introduce a structured procedure for a proportionality test to be applied to the new provisions adopted by the Member States for managing their regulated professions.

Given the public service nature of the work done by healthcare professionals, the specific nature of which is not sufficiently taken into account in the draft directive, the draft decision proposes excluding such professions from the scope of this text. With regard to healthcare professionals and the need to protect public health, the ENVI Committee considers that the Commission’s proposals would be too complex to implement and would involve too much red tape.

You can access the draft opinion of the ENVI Committee at this link.

The text of the Proportionality Test Directive is available in al EU language at this link

Health in the Digital Society. Digital Society for Health.

On October 16 and 17, GIRP was present at the conference ‘Health in the Digital Society. Digital Society for Health', organised in Tallinn by the Estonian Ministry of Social Affairs as part of Estonia's Presidency of the Council of the European Union.

Over 2,5 days, 700 delegates participated in the dense and constructive discussion around the future of healthcare, the impact of digitization on the sector now and tomorrow, blockchain, e-health, m-health, implementation of the GDPR, among other developments in the sector.

Three key points stood out at the end of the conference:

-       Patients, citizens must have control over their health data and must remained informed and educated on the issue.

-       Data governance, interoperability and safety are key in the move towards free flow of data

-       Patient data and cross border exchange of data at the heart of health innovation.

Veterinary medicinal products

The Council agreed its mandate for negotiations with the European Parliament on all three legislative proposals of the Animal medicines package, and a final version of the laws is expected in 2018.

The three regulations, on veterinary medicines, medicated feed and separating veterinary medicines’ approval from human medicines, were proposed by the Commission in September 2014, aiming to increase the availability of veterinary medicines in the EU, while simultaneously strengthening rules on using antibiotics in animals to fight antimicrobial resistance.

More information available here.

High-level round table

The next Round Table gathering European Health Ministers and Heads of European pharmaceutical companies is planned to take place in autumn 2018 during the Austrian presidency in the Council. A newly convened High-Level Group (HLG) is supposed to prepare the agenda and contents of the meeting.

GIRP was invited to attend the first inaugural meeting of the HLG on 30 November 2017 in Malta. The meeting focused on recommendations on issues of major strategic significance within the pharmaceutical framework, as for example guaranteeing access to innovative and affordable medicines. During the meeting, different working groups were created to work and communicate with each other.

GIRP is therefore part of two working groups on sustainable availability of medicines and equal access of centrally authorised products.

GIRP hosts the Fight the Fakes partners meeting in Brussels

GIRP hosted the Fight the Fakes partners meeting in Brussels on October 23. 

The Fight the Fakes campaign partners representing healthcare professionals, academia, NGOs, the generic and research-based pharmaceutical industry, healthcare distributors, and consumer protection organizations met to work on their ongoing plans to raise awareness of the widespread sale and use of falsified medicines across the world and the dangers associated with these fake products.

Potentially 15% of medicines worldwide and up to 30% in some regions being fake. In signing up to join FtF, GIRP and the other partners commit to raising awareness across their organizations around the world. In this way, FtF reaches not only to regulators as well as the general public but also thousands of nurses, pharmacists and other stakeholders of the healthcare sector.

During the face-to-face meeting the partners reinforced their commitment to the campaign and to fighting the issue of falsified medicines, by increasing the awareness in and out of their organisations and by intensifying the exchange between the FtF partners. The FtF secretariat is currently held by IFPW and during the meeting in Brussels FtF partners celebrated the joining of NABP as the 35th partner.

A detailed Fight the Fakes press release is available here.

PGEU appoints new Secretary General

The Pharmaceutical Group of the European Union (PGEU) has appointed Ms Ilaria Passarani as its new Secretary General.

Ms Passarani was appointed by the PGEU General Assembly on 19th December and will be responsible for providing strategic direction and leadership of the PGEU. Ms Passarani, from Italy, is currently leading the food and health department at the European Consumer Organisation (BEUC) and is a member of the management board of the European Medicines Agency.

More information available here