Dublin, Ireland – Innovation, technology, digitalisation, partnership, and entrepreneurship – all contribute to building efficient and resilient healthcare systems. The need for collaboration in these areas was consensus among delegates gathered in Dublin, Ireland for the European Healthcare Distribution Association 59th Annual Meeting and Conference. While patients are the ultimate beneficiaries of the partnership between pharmaceutical manufacturers, healthcare distributors and pharmacies, the move towards cooperation between healthcare stakeholders also makes for valuable contributions to the knowledge-based economy.

The event set a forward-looking tone for the discussion, by gathering an impressive line-up of speakers from the political, policy, business and healthcare worlds to look at how innovation, investment and technology are driving forces for the future of Europe’s healthcare systems. The power of all healthcare stakeholders working in collaborative partnerships brings value to their common constituents – the patients. It was agreed that there are clear challenges to face as each operator is oftentimes focused on its own segment of the pharma sector, however it was clearly understood that where there is a will there is a way, and while the sector as a whole is slow on ceasing possible opportunities for greater collaboration, the future is bright for patients as industry and healthcare distributors express clear commitment to increasing innovation and entrepreneurship.

Perspectives from a global pharma CEO

Dr. Severin Schwan, Chief Executive Officer of Roche, while addressing delegates on the issue of ‘Digital’ Healthcare spoke about the “evolving supply chain” and how his organisation is continuously developing a strategy towards “personalised healthcare” (PHC). PHC has come from a time when focusing on broad patient segments was the order of the day, to the time of focusing on specific patient groups with targeted medicines, towards individualised treatments for the future. These evolutionary moves have been driven by power of technology and increased digitalisation in healthcare. To deliver on PCH strategy, there is a need for strategic positioning between the value chain partners for improved patient care.

Dr. Schwan addressed the great potential of real-world data analysis while acknowledging challenges in relation to access, analysis and use. He said that “when assessing the supply chain, we see many digital opportunities and the value in working with value chain partners in the quest to delivery on the promise of doing what patients need next. Data insights leveraged along the value chain lead to smarter, more efficient R&D, while vastly improving access and personalised care.”

Europe needs to pick-up the pace on big data in healthcare

Dr. Schwan did however throw down the gauntlet to Europe – it is lagging, lagging far behind in the areas of digitisation and big data. Citing the US and China as being leaders in the space, Europe needs to do more, much more. Dr. Christa Wirthumer-Hoche, Head of the

Austrian Medicines and Medical Devices Agency and chair of the European Medicines Agency (EMA) Management Committee, responded to the observation and concern by setting out Europe’s health digitalisation and big data in healthcare agenda and priorities.

In responding to Dr. Schwan’s address, GIRP President, René Jenny, said that “GIRP and its members, firmly believe in the power of collaboration and partnership. We believe that a strong relationship with partners throughout the value chain contributes to building efficient and resilient healthcare systems. Technology and digitalisation in healthcare will favour innovation and bring forth better adapted solutions for better access and improved patient care”, he said. GIRP shows dedication to building broader and deeper alliances with our industry partners and look forward to being part of that journey as our supply chains are evolving into the future.

Falsified medicines directive – the final countdown

On Saturday 9 February 2019, deadlines set by the EU Delegated Regulation on Safety Features, which is part of the so called Falsified Medicines Directive (FMD), will kick-in and medicines verifications systems will go live across Europe. On that date, the entire pharmaceutical sector will have to comply with the requirements established in the falsified medicines legislation.

“Across Europe, each healthcare distributor sees thousands upon thousands of medicines packs pass through their distribution centres daily”, Monika Derecque-Pois, GIRP Director General, explained. “Our picking, packing and shipping processes to our pharmacy and other healthcare professional clients would grind to a stand-still if pharmaceutical full-line wholesalers were required to verify each pack. Healthcare distributors will only verify medicines if they do not receive them directly from a manufacturer or their pre-wholesaler.” While expressing high confidence in the readiness of GIRP members, Derecque-Pois emphasised “that there are still a number of important issues to address, some challenges to overcome and very, very little time to get it done and more importantly tight deadlines left to get it done right.” 

Great progress but still some way to go

The European Medicines Verification Organisation (EMVO), of which GIRP is a founding member, is missioned with establishing the central hub to which all Marketing Authorisation Holders (MAHs) and the repository system of the different National Medicines Verifications Systems (NMVSs) need to connect. All these connections are mandatory for the entire system to become fully functional, operational and interoperable. “While enormous efforts have been underway and work currently reaches new highs, there is concern at the forefront of the minds of those responsible for getting the systems full operational on time” Andreas Walter, EMVO General Manager stated during a discussion on the issue at the meeting. “To-date only close to 900 of the near 2,300 MAH on-boarding partners are in the process of connecting to the European hub and only 8 national systems have connected. While encouraging to see the numbers rising daily, we have a long way to go”, he said.

Healthcare distributor preparedness

GIRP is the European organisation representing over 800 healthcare distributors which as pharmaceutical full-line wholesalers hold not more than one tenth of the total number of wholesale distribution authorisations in Europe. GIRP conservatively estimates that there may be as many as over 10,000 wholesale distribution authorisation holders in the market place and all will need to establish a connection to their respective national systems in order to discharge their regulatory obligations as set out the FMD and DR.

GIRP is concerned about the status of the European Medicines Agency (EMA) EudraGMDP database which lacks data on wholesale distribution authorisation holders from some countries. “We urgently need to have a fully populated, fully updated database of all legitimate authorisation holders and call upon National Competent Authorities (NCAs) to ensure at a minimum that national data bases are fully operational. National system owner need a reliable primary data source to ensue only legitimate authorisation holders are granted connections to the NMVSs.”, Monika Derecque-Pois stated. We absolutely need to have the active support by NCAs in reaching out and communicating with all MAHs, wholesale distributors and dispensing entities.

All discussants, recalled their dedication, commitment and high energy investment in supporting all system users’ readiness ahead of the deadline.

GIRP’s landmark annual conference brings together top leaders, senior executives and decision-makers from healthcare distributors, the pharmaceutical industry and healthcare supply chain stakeholders to share information, learn about best practices, and be introduced to new products and services, with the objective of effectively serving patients.