During its autumn meeting, the European Healthcare Distribution Association (GIRP) placed medicine shortages at the top of its policy priorities.
Bernd Grabner, the President of GIRP, said while speaking on the sidelines of the conference about its membership, explained how healthcare distributors are acutely aware of how “shortages are a growing problem across the globe” and “how it has become a major media headline and political concern everywhere”.
“Shortages are not a new issue nor are they limited to individual nations or geographical regions,” Grabner said.
The Director-General of GIRP, Monika Derecque-Pois, added that the solution to the problem must take into account the fact that the issue is “global, multifaceted, and complex…We are witnessing an onslaught of EU national specific actions that are aimed at addressing a problem that can only be truly addressed by a more comprehensive set of measures.”
Finding proportional solutions to a complex global problem
While acknowledging the seriousness of the problem and the significance for patients, GIRP accepts that there is not much that they can do to help address the issue.
Grabner has spoken about how finding effective solutions is “dependent on factors beyond the control or direct influence of healthcare distributors”. He has urged the authorities to acknowledge the “real causes” and focus on finding “proportionate measures” rather than measures that have little practical impact.
GIRP has also taken the view that almost all cases involving shortages have a manufacturing-related component, something Grabner stressed when he said that “the reasons for shortages are many. They include technical, quality, and economic issues at the manufacturing level, as well as a lack of investment in production capabilities, low pricing, unexpected demands, and supply disruptions”.
Backing his views on this, he said that the “data published by National Medicines Agencies suggest that manufacturing and quality issues are attributed to the highest number of incidences of shortages.” “While there is no harmonised categorisation of terms used by authorities for the root causes”, it can generally be said, “that manufacturing/quality-related issues account for more than 60% of cases of shortages and marketing/commercialisation for more than 27%”. By contrast, citing national agency’s official figures, Grabner stated that “parallel trade in Spain, accounts for only 2%”. However, almost weekly we now see national measures focused on addressing the lesser causes of shortages.
To this end, Grabner welcomed the “viewpoint” of the European Commission (DG SANTE) regarding national measures for addressing shortages as pointed out during the conference, which he said recognised “it’s important that not one single Member State introduces a measure that impacts another. Member States working with measures that are only for their own territory and which have possible negative effects on others. In an internal market, we have to be very prudent with stockpiling and we will have to listen to the Member States to see how they see the best measure to mitigate the problem”.
Tackling shortages together
GIRP’s Director General has argued for an “in-depth dialogue with governments and supply chain stakeholders. Our members, healthcare distributors, can focus on an optimal allocation of the available market supply and help mitigate the impact of a shortage by keeping buffer stocks.”
There is a need for a monitoring system which not only uses notifications from manufacturers but takes the signals from the market about lacking medicines into account. To this end, the conference, Derecque-Pois said, aimed at comparing systems involving all supply chain stakeholders and our objective is to establish requirements for a shortages’ monitoring system apart from manufacturers notification systems.
Grabner later referenced information exchange systems in a number of countries and added that a need exists for a system that collates non-commercial supply chain data from manufacturers, healthcare distributors, and pharmacies (validated by authorities) that provide early warning indicators of shortages. This sort of system is accessible to all supply chain participants and would allow us all to respond to potential disruptions in a timely and effective manner. The sooner we have the information, the better we can put in place plans to help mitigate the situation.
Addressing recent calls from some stakeholders and authorities to use the European Medicines Verification System (EMVS) for shortages monitoring, Grabner disagreed saying, “The system is not designed for this purpose”. He outlined that the system will require a significant re-design and major industry investment. It can only meet this expectation when it contains accurate stock level data. Grabner later pointed out that “the system does not contain actual stock level data. As not all packs are checked-out of the system, it contains multi-country packs, which are counted for all countries where they could be potentially sold in the number of packs uploaded in the system leading to a huge overestimation of available supplies. On the other hand, there is a complete lack of demand-side data, which can only be available through a link to full e-prescription systems in the countries”.
Supplies can only be provided from what is received
While acknowledging that there is a need for authorities to address a genuine shortage due to exports, Derecque-Pois stated that “Healthcare distributors are only in a position to supply what they themselves receive,” adding, “Restrictions, which result in temporary barriers to the single market, should only be deployed when necessary and appropriate to achieve their objective”.
The restrictions of supply must be adopted based on transparent, publicly availability, and non-discriminatory criteria that are known in advance by healthcare distributors. The restrictions also must clearly follow the criteria established by the European Commission for this purpose.