The longstanding problem of shortages of health products, medicinal products and medical devices is set to continue despite numerous reports, proposals and public action plans on the subject.
The health sector typifies the issues of reducing our dependence on sensitive products and increasing the autonomy of our strategic sectors. In fact, there are worrying signs of supply tensions and even stock shortages, which are becoming more and more frequent, as highlighted by the health crisis caused by the coronavirus pandemic. The crisis has seen a huge surge in demand for medicinal products (particularly those used in anesthesia and intensive care) and essential products (masks, gloves, but also respirators) for this disease. The situation has revealed both the vulnerability of production lines and the structural dependence on non-European suppliers in some areas.
- Admittedly, many initiatives in this area have been launched and strengthened since the crisis, but no coherent overall public policy has emerged and there are no noticeable results yet.
Greater awareness of the risks involved has given rise to a number of initiatives or programs : identification of “medicinal products of major therapeutic interest” (MITM), combined with certain measures to safeguard supply (2016-2017, measures strengthened in 2020-2021), Roadmap on “combating shortages and improving the availability of medicinal products in France” (2019-2022) ; measures taken during the health crisis and as part of the recovery plan, in particular calls for proposals or expressions of interest (CFP and CFEI, 2020-2021) ; guidelines in the amendment to the “Strategic Agreement for Health Industries and Technologies” (2021-2022) ; announcements by the Strategic Council for Health Industries (CSIS) (June 2021) concerning health independence.
- In this context, the European framework is becoming more widespread, given the increasing sophistication of health products, globalization and the complexity of value chains, which makes it unlikely that exclusively national strategic independence will be achieved. In the wake of the crisis, the Commission recognizes the importance of European independence in certain strategic areas, including health.
At the end of 2020, the Commission first presented three proposals for new regulations to improve policy coordination in the event of health crises within the European Union : serious cross-border health threats, a revised mandate for the European Centre for Disease Prevention and Control, and the European Medicines Agency.
It has proposed a pharmaceutical strategy and launched a “structured dialogue” (to be held in the first half of 2021), with all stakeholders, to gain a better understanding of supply chains and their vulnerabilities. The strategy presented includes a section on support for industry and a chapter on improving the resilience of the European healthcare system.
In parallel to these developments, on September 16, 2021 following extensive consultations, the Commission decided to create a Health Emergency Preparedness and Response Authority (HERA) within the Commission based on the American model. One of the tasks explicitly assigned to HERA is to address vulnerabilities and strategic dependencies within the Union in terms of the development, production, supply, storage or distribution of medical countermeasures.
In the end, France must actively engage with the European strategy to regain its health independence. But it must also pursue a national policy addressing the major issues identified.
- The need for health products and their required availability for patients has led public authorities to take measures to protect supply for around 15 years now.
These measures are based directly or indirectly on therapeutic criticality criteria (would a shortage of a certain medicinal products be life threatening for patients ?) and are adapted where appropriate to the circumstances at that time (does a pandemic situation make a product essential that wouldn’t usually be in normal times ?). The second approach is the most common one in the case of medical devices (MD).
These analyses have thus led to the identification of two product categories in France, each with differing protection measures :
- On the one hand, products that are theoretically deemed necessary to respond to health emergencies are subject to strategic stockpiles and, where appropriate, public production. Some MDs are identified through this approach.
- On the other hand, there is the much broader area of MITMs, which has no equivalent in MDs. MITMs are subject to recent protection measures (requirements to build up stockpiles and file a “PGP” shortage management plan), which make it possible to create a crucial “preventive shield”.
However, in the case of several thousand MITMs, it looks like there is no way of building on the measures already adopted, for reasons that are essentially related to the potential costs of such measures at national level. Therefore, if we do want to adopt even stronger measures to protect supplies at national level, we should concentrate on the most sensitive products, in terms of the impact of their potential shortage on patient health and the likelihood of these shortages occurring.
- In this context, this Mission – launched at the initiative of the Moroccan High Commission for Planning – had two key objectives
- To propose a methodology for identifying particularly critical medicinal products and medical devices for which a continuous supply must be ensured, outside of crisis situations, to validate it by applying it to a few specific areas and to assess the possibility of its rollout, in order to rapidly provide the public authorities with the priority targets of the health independence policy,
- To propose solutions to ensure a continuous supply of the critical products identified, and determine the conditions and coherent framework likely to promote their rollout.
- For nearly 10 years, various recommendations have been published to combat medicinal products shortages and there are still persisting or perhaps even increasing tensions. This is undoubtedly due in part to the fact that no list of critical drugs has been established that could guide and prioritize the policies to proceed with. While it is inevitably subject to contradiction and criticism, this type of list has been established in Germany and the US, for example. The work of structuring the data collected by the French National Agency for the Safety of Medicines and Health Products (ANSM) from drug manufacturers has recently progressed and now allows us to conduct analysis. The analyses performed by the Mission have made it possible to implement a method for identifying “critical medicinal products” by merging two categories of data :
- An assessment by relevant clinicians of the major therapeutic interest and irreplaceability of certain medicinal products,
- The vulnerability characteristics of the production chains for these products, documented in the ANSM records : number of operators, suppliers and production sites, manufacturing location of the active ingredients and production location of the finished product.
The exercise was completed for two therapeutic areas : cardiology (for certain indications) and anesthetics/intensive care, and thus made it possible to identify the immediate priorities for public action that should be selected. Applying it to all therapeutic areas will require the adaptation and automation of certain data processing tools.
Translating the measures adopted for the pharmaceutical sector to apply to medical devices is no simple task. Establishing a list of critical medical devices has not been ruled out, but no Member State in Europe has produced one. However, the Mission has still made a pragmatic proposal, based on the identification of medical devices considered essential in health crisis situations, and of vulnerabilities in value chains, but without professing to have performed exhaustive analyses, for lack of available data.
- Regarding the identification of possible courses of action, the Mission advocates a simple framework for action adapted to the characteristics of the identified vulnerabilities.
It therefore recommends :
- to keep strategic stockpile and production measures under public control for products used in exceptional health situations (as is already the case),
- to extend production under public control (recourse to the French Armed Forces Central Pharmacy or to public-private partnerships, with their feasibility having been demonstrated during the crisis for the production of neuromuscular blocking agents), in anticipation, to certain identified critical products, and also to clearly target public support for investment on these products within the framework of CFEI or CFP (modernization or relocation of the productive equipment),
- to monitor and evaluate the implementation of the measures recently selected for all MITMs (shortage management plan, stockpiles),
- to lead manufacturers to adopt, for their entire profession, a comprehensive Quality System, following the example of the best quality practices of other sectors (some companies interviewed by the Mission already have this type of system) ; to standardize the drafting of business continuity plans, based on this Quality System and on systematic risk analyses (especially in the relationship with suppliers) ;
- to adopt regulatory simplifications likely to promote the intra-community distribution of health products (equivalence of marketing authorizations (MA) for old products and simplification of MA variations, access to package inserts by QR code) or to avoid shortages (extension of the deadline for compliance with the EU medical device regulation (MDR) for devices already on the market),
- finally, to pursue relevant policies for all products that can help avoid shortage situations : pricing policy can take greater account of identified critical products and the national industrial footprint (as a legislative provision now explicitly authorizes), while public purchasing policies could avoid contributing, through certain techniques used (single contract award, buy-on-account clause, misidentification of quantities), to creating supply tensions, or put greater value on security of supply criteria.
The Mission noted the current operational nature, to a greater or lesser extent, of the measures already recommended and the conditions required for their implementation :
- some of the measures listed are already in force (strategic stockpiling of products for exceptional health situations) ; the Mission did not conduct further investigations into their effectiveness,
- others are in the process of being implemented (shortage management plan and building up stockpiles within companies), but the ANSM should be provided with the necessary management and investigative resources (particularly in terms of appropriate information systems), to help mitigate the risk of failure,
- some are already in practice, but should be better targeted on priority products, which are doubly critical from a therapeutic and manufacturing point of view (CFEI and CFP for productive investment operations on existing facilities or relocations),
- others should be planned in a preventive and proactive manner (production under public control), unless forced to resort to risky means under the impact of the emergency or crisis,
- the contextual measures reached concerning the adaptation of purchasing or pricing techniques for health products will need to be implemented, which requires a controlled and evaluated application,
- Lastly, some of these measures, particularly those of a regulatory nature, deserve consideration at community level.
Overall, the Mission underlines the need for a system rationalization program for collecting and monitoring information on the supply of health products. Over the past two years, various actors (ANSM, the French Chamber of Pharmacists, pharmaceutical companies, central purchasing agencies, hospitals) have worked on initiatives to digitize information on stocks, tensions and supply chains for health products, but these initiatives lack clear coordination. The Mission recommends establishing a comprehensive map of tools for managing stocks of medicinal products, in vitro diagnostic medical devices (IVDMDs) that contribute to the management of tensions and shortages among public stakeholders at different levels, as well as digital procedures for collecting data of general interest from private stakeholders, and creating a roadmap for the evolution of these elements to secure and optimize their value for the benefit of the policy for dealing with supply vulnerabilities. The ANSM should set objectives relating to information systems to support the processing of collected information and processes for anticipating and responding to shortages in line with recent European guidelines, while providing it with the appropriate resources to achieve these objectives in the very short term.
- Lastly, the Mission notes the need to provide strong and sustainable interministerial governance to manage the issue of prevention and of responding to health product shortages.
Public action to combat shortages and to restore and maintain our sovereignty in the field of healthcare at the highest level brings into play many dimensions, competencies and ministerial domains. Until now, no ministerial department or agency has shown the Mission that it is in a position to ensure this action is taken with the appropriate legitimacy, authority and resources. The Mission therefore advocates the close coordination of all ministerial actors in health product policy. It examined three alternative organizational scenarios to ensure the continuation of the objectives and resources allocated to the independent health policy. The creation of an interministerial delegation for health independence, with purely promotional and coordinating resources, would not meet the challenges highlighted in this report. Creating an “Agency for Health Sovereignty” (which would then deal only with securing supplies), a counterpart of the French National Agency in Health Innovation (AIS), which was created following a decision in the last CSIS, or extending the CSIS’ responsibilities to the problems of dealing with supply vulnerabilities, appear to be appropriate solutions and would work in synergy with HERA. The Mission recommends the second option, which is simpler to implement and offers synergies.
ABBREVIATIONS & ACRONYMS
|Call for proposals
|Agence de l’Innovation en Santé (French National Agency in Health Innovation)
|Call for expressions of interest
|Agence Nationale de Sécurité du Médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products)
|Conseil Stratégique des Industries de Santé (Strategic Council for the Healthcare Industries)
|In vitro diagnostic medical devices
|Health Emergency Preparedness and Response Authority
|Medical Device Regulation, directive 2107/745
|Médicament d’Intérêt Thérapeutique Majeur (Medicinal products of major therapeutic interest)
|Plan de Gestion des Pénuries (Shortage management plan)