Monika Derecque-Pois and Bernd Grabner

"The role of pharmaceutical wholesalers is strengthening in response to the new challenges"

Monika Derecque-Pois, Director General and Bernd Grabner, President shared some important insights regarding the current state of play as they see it from the perspective of the European Healthcare Distribution Association (GIRP). They highlighted that while the work of wholesalers used to be often invisible, the COVID-19 pandemic changed that radically. The experience of past months has also brought important changes for the sector.

How do you see the role of pharmaceutical wholesaling in the pharmaceutical supply chain and how would you assess the sector's position in healthcare as a whole?

Full-service healthcare distributors are the invisible, yet vital link in the healthcare supply chain ensuring access to medicines for European patients.

Ensuring the availability and continuity of supply of all healthcare products and services to their customers, which include retail pharmacies and other dispensing partners, stands at the forefront of their activities. As they are in a unique position connecting crucial supply chain stakeholders, full-service healthcare distributors have an in-depth view of the flow of medicines in the supply chain. Thus, they provide in addition to the full product range, a full range of services to all partners in the supply chain, including manufacturers, pharmacies, hospitals, nursing homes, patients (through their pharmacies) as well as to governmental institutions and society.

Throughout the COVID-19 crisis, full-service healthcare distributors have proven their resilience and efficiency in ensuring continuous supply of medicines. Full-service healthcare distributors put in place successful contingency plans to respond to unprecedented levels of demand in a rapid manner. Government, customer, and patient confidence in the supply chain at community pharmacy level was strengthened and the crucial role of our sector, which is mostly invisible, due to our B2B function, became very visible.

With Member States and the healthcare supply chain now fully engaged in one of the most important immunization efforts in living memory, full-service healthcare dsitributors have demonstrated their ability to adapt to the extraordinary requirements imposed by the unrolling of the new vaccines. As new and high volumes of vaccines become available, full-service healthcare distributors partnership with community pharmacies and other community healthcare professionals as well as with all existing healthcare channels should be leveraged to ensure efficiency, and ultimately success, in vaccinating as many citizens in the shortest possible timeframe and over the long term as we begin to consider booster shots.

GIRP has been long working with members and with institutions to ensure improved recognition of full service-healthcare distributors public service role and its classification as being part of the critical infrastructure. The moment is perfect to harness the increased visibility, highlighting that full-service healthcare distributors ensure continuous supply, maintain buffer stocks, optimise stock allocation and finance the supply chain.

The players of the sector have made several improvements in the last 5 years. What are the main developments that affect your operation and activities as well?

Digitalisation is also a key part of the modernisation and sustainability of the pharmaceutical sector. The COVID-19 crisis essentially highlighted the need for change and for a more sustainable and resilient system. All along the pharmaceutical supply chain, digitalisation is significantly impacting our sector: from the digitalisation of health professionals’ skills to innovation in data protection, especially related to health. 

Communication between full-service healthcare distributors and pharmacies is already highly digitalised, although in the communication between the pharmaceutical industry and our members there is still significant room for improvement. Stakeholders must identify areas of cooperation and adapt their business models to evolve towards a collaborative approach to better serve patients. They must be part of the evolution shifting from the cumulation of proprietary platforms, break down the silos and move towards a European-wide harmonised infrastructure, gathering stakeholders and regulators around a shared goal. To reach this objective, regulation ought to be carefully drafted and implemented to protect patients’ rights while also incentivising innovation for stakeholders.

In the face of new challenges, increase in medicines shortages across Europe, COVID-19, the specialisation of the healthcare sector and of pharmaceutical distribution, the steady revision of the regulatory framework at European level and national level, GIRP has continuously ensured that the efforts carried by full-service healthcare distributors to guarantee access to medicines for European patients be recognised.

Compliance to new regulation comes with significant financial commitments and investments. GIRP has remained dedicated to showcasing the efforts carried by our membership in this regard, especially at a time when the European Commission is working towards the revision of the pharmaceutical legislation.

The Hungarian Association of Pharmaceutical Wholesalers (HAPW) has played and continues to play a major role in the field of medicine safety, ensuring that the right medicine is in the right place and at the right time, and they also support the fight against counterfeiting. How do you evaluate the work of HAPW’s member companies in these important fields?

GIRP is happy and proud to collaborate with HAPW as an association as well as with its member companies. Full-service healthcare distributors (full-line wholesalers) hold a vital position to in ensuring availability medicines and medical devices by bundling transactions, which in turn, allows for more efficient as well as more effective transactions from manufacturer to pharmacies and other healthcare professionals as well as hospitals. Full-service healthcare distributors (full-line wholesalers) also play a key role in mitigating shortages, sharing sustainable solutions such as providing both expertise and infrastructure, advocating for full, fair and monitored implementation of existing regulations and calling to set in motion a European-wide strategy to mitigate the issues.

HAPW member companies continue to act as catalysts in advocating for sustainable solutions which prioritise medicines availability, accessibility and affordability by outlining the core function of full-service healthcare distributors (also referred to as pharmaceutical full-line wholesalers), being the vital link for the fair, efficient, timely and safe distribution of all medicinal products, including medical devices and other medical supplies, to patients across Europe. HAPW member companies have successfully implemented the Falsified medicines directive as well as its delegated regulation, are successfully connected to the National Medicines Verification System in Hungary and thereby prevent patients from the risk of falsified medicines, when receiving them via the legal supply chain.

HAPW members have also led the way in Europe in COVID-19 vaccine distribution and we are very proud that the Hungarian full-service healthcare distributors have managed to cope even with the most demanding storage and transport conditions of COVID vaccines, delivering the vaccines safely and reliably to vaccination points.

How would you evaluate your cooperation with HAPW and its member companies?

We have an excellent relationship with the members of HAPW and thank them for their support through the 25 years of cooperation and we very much look forward to an even stronger and deeper cooperation with all HAPW members into the future.

HAPW has remained a longstanding and ever-reliable partner of GIRP. Through various committee work, governing body activities, events and conference, HAPW has consistently shown its support and engagement with GIRP. We are now delighted to count Dr Antal Feller as new member of the GIRP Board. 

How do you assess the work and role of pharmaceutical wholesaling during the COVID-19 pandemic? Please highlight some personal experience.

As we reflect on the last 18 months, full-service healthcare distributors have soared from the background of the healthcare sector to the very frontline of the COVID-19 pandemic – proving their resilience, strength and key role on the road to recovery. From the very beginning of the pandemic, full-service healthcare distributors stepped up immediately, rising in the spotlight. COVID-19 catapulted them into working relentlessly to ensure medicines availability to all patients across the EU, to guarantee the safe and efficient delivery of medicines and medical devices to patients and continuously provide a rapid, safe and manufacturer independent supply of products, including life-saving medicines, to the sites of healthcare provision. The defining difference of full-service healthcare distributors in the fight against COVID-19 is resilience, our ability not only to absorb shocks but to use them to build best practices and innovative solutions.

As EU Member States began mapping out their COVID-19 vaccines distribution schemes, the robust strength of our sector proved full-service healthcare distributors are crucial partners in the swift and effective deployment of vaccines within the EU Member States. With more and more vaccines continuing to be developed and authorised and potential COVID-19 booster shots being already deployed to the most vulnerable citizens, full-service healthcare distributors’ involvement in distributing and administering the COVID-19 vaccines has been and will remain vital in making sure vaccines reach all communities across Europe.

In constant contact with its members, EU authorities, and supply chain stakeholders, GIRP urged EU institutions and Member States to act quickly to support full-service healthcare distributors who heavily invested in stocks, staff and systems and put in place business continuity contingency plans to ensure the safe and efficient delivery of medicines and medical devices to patients.

In doing so, GIRP called for:

• The full implementation of “Green lanes” for vehicles carrying medicines and medical supplies to be secured across all EU/EEA territories.
• Authorities to consider the detrimental impact of export bans imposed at national level on the availability of medicines in some EU markets with the risk of creating shortages in other EU Member States who depend on these imports. 
• National authorities to urgently classify full-service healthcare distributors as critical infrastructure to maintain the continuous supply of medicines and access relevant national resources where needed.
• National authorities to enable stock optimisation measures introduced by full-service healthcare distributors or their customers to restrict deliveries of the number of products dispensed to guarantee all patients are able to receive treatment.
• Authorities to recognise the added value of full-service healthcare distributors in mitigating shortages.
• Regulatory flexibility: Discussions led to the introduction of measures including flexibility with regards to the validity of GDP certificates and wholesale distribution authorisations, importation of active pharmaceutical ingredients (APIs) and finished products, labelling and packaging requirements with flexibility to facilitate the movement of medicinal products within the EU, as well as flexibility regarding the deployment and physical presence of the Responsible Person, and the use of new equipment or newly authorised premises for storage and distribution as well as remote inspections. 
• Authorities to recognise the capability and expertise of full-service healthcare distributors in holding rotating emergency stocks, preventing products from expiring by applying FEFO (first expired first out) principles, through the integration of emergency stocks into normal operations (thereby strictly respecting the agreed buffer quantities), which is a unique capability of our sector.
• Authorities to ensure safe and efficient vaccines distribution through full-service healthcare distributors and their existing infrastructure, network and expertise.

We are very pleased that most of our recommendations have been swiftly implemented or are currently being implemented.

How would you describe your cooperation with the pharmaceutical wholesalers?

GIRP, the European Healthcare Distribution Association, is the umbrella organisation of full-service healthcare distributors (wholesalers) in Europe. It represents the national associations of over 750 pharmaceutical wholesalers serving 33 European countries, as well as major international and pan-European healthcare distribution companies. We have excellent relationships with many of the leading companies and national associations. We actively encourage more cooperation with associations and companies in our daily work. We have many new challenges to face not least the upcoming revision of the EU pharmaceutical general legislation which will require all hands on deck and to ensure the best outcome our mutual cooperation will be more important than ever before. Members will need to work with their policy makers responsible for EU affairs to ensure our common voice has influence on the legislator.