Who has regulatory responsibility for stocking PPE in ambulatory settings, and how does it work in practice?
The COVID-19 pandemic created an unprecedented demand for personal protective equipment (PPE) (e.g. gloves, medical masks, goggles, etc.), and large disruptions in the global marketplace made it difficult for virtually all countries to obtain PPE for their own needs in the first months of the pandemic.
In April 2020, the European Observatory on Health Systems and Policies published a policy snapshot documenting how 24 countries were initially finding new PPE based on information recorded in the COVID-19 Health Systems Response Monitor (HSRM). Strategies included: importing PPE, relaxing guidelines for the use of PPE, ramping up internal production, withdrawing from emergency stockpiles, and introducing PPE monitoring systems. Several countries centralized their procurement and/or distribution as a result of the shortages during the initial months of the pandemic.
Looking forward, countries are now faced with the challenge of figuring out how to continue ensuring their health care providers have sufficient PPE, in particular during the winter months when the health system may face a second wave of COVID-19. Several countries are evaluating how to design and reinforce policies and mechanisms for stocking PPE, while clarifying the responsibility for stockpiling between national authorities and health care providers. The design of these measures not only influences the equity of PPE distribution but also provides opportunities to centralize procurement and benefit from economies of scale. Even in instances where the hospital sector has already developed their own policies and mechanisms for stockpiling PPE linked to emergency plans, this is less often the case for health care providers in an ambulatory (outpatient) setting. This policy snapshot summarizes the regulatory obligations regarding PPE stocks for ambulatory care providers, and provides some insight into how this works in practice.
The information presented here is based on the experience from six countries and on data collected between 6 and 17 July 2020, from country experts contributing to the HSRM platform. First, this policy snapshot shares details from each country about the regulatory background, with an overview in Figure 1, with some further details about the implementation in some countries and policy lessons.
Figure 1: Who is responsible for stocking PPE in ambulatory care during the COVID-19 pandemic?
Denmark will establish a new agency to manage PPE stocks as a result of COVID-19
It is the providers’ responsibility in Denmark to provide services in accordance with the law and guidelines. Providers receive fees (e.g. self-employed physicians and companies) and must buy PPE out of their income from these sources. However, the authorities do not set standards for stocks of PPE, and therefore create an indirect incentive for providers to minimize costs by stocking low amounts of PPE. In practice, regulation of providers from the national level is quite limited and managed through standards for services and fees.
Following the COVID-19 crisis, however, the national government has decided to establish a national agency which will be responsible for managing the PPE stock, ensuring an adequate supply and storage of PPE, and maintaining an overview of stock across the public sector. Hence, it will be up to the new agency to decide the size and maintenance of the stocks in ambulatory care and to inform other stakeholders of the new requirements. This agency will be operational from August 2020.
Self-employed ambulatory health care workers are in charge of their PPE stock in France
The COVID-19 crisis has triggered a debate regarding responsibility for the provision of PPE to ambulatory health care providers in France. While the general rule is that the responsibility lies with individual employers, the obligations for self-employed health professionals such as ambulatory health care providers are not clear. There seems to be a juridical gap in this regard: while some interpret that the state should have responsibility, others think that individual physicians should have to take necessary precautions and have their own stock of masks. For example, a former Minister of Health, when interviewed by a parliamentary investigation committee on the PPE crisis, declared that the responsibility should have been assumed individually by self-employed ambulatory care professionals.
In 2013, the General Secretariat of Defense and National Security (SGDNS) published a note entitled, ‘Doctrine for protecting workers from highly pathogenic diseases with respiratory transmission’. This note established that the national stock managed by the Establishment for Public Health Emergency Preparedness and Response (EPRUS) only concerns surgical protective masks used by sick people and their contacts, while the stocking of protective masks for health personnel—notably FFP-2 masks—is the responsibility of employers. This effectively means that hospital directors, owners and individual health care providers in the ambulatory sector (as in France they are self-employed) are responsible for stocking their own PPE. SGDNS establishes that each employer should decide the size of the stock by considering the average length of an epidemic with several waves (8 to 12 weeks), the time the mask is worn, the size of the target population, and the manufacturing capacity during a crisis.
German sickness funds and physicians came to a three-month agreement to facilitate distribution of PPE during the peak of the pandemic
While the German hospital sector released guidelines for ensuring the supply of PPE, no similar regulations have been released related to stocking PPE for ambulatory providers. Between 10 March and 10 June, the Federal Association of Statutory Physicians and Federal Association of Sickness Funds had an agreement in place regarding the purchase and distribution of PPE to ambulatory physicians. The agreement introduced a special procedure to retrieve the centrally procured PPE from the Federal Ministry of the Interior’s procurement office with new processes for billing and financing PPE. This distribution arrangement reflects the German method of self-governance in the health system, as there is not an overarching regulatory body for both physicians and health insurance funds.
Italian regional, local or organizational authorities apply national directives to their own contexts
The Law Decree 81/2008 established that employers (including General Managers of Local Health Units) in Italy have the responsibility of ensuring that workers are equipped with proper PPE. The Department of Civil Protection and the Local Health Authorities (LHAs) are responsible for the distribution of PPE, with LHAs also in charge of surveillance and monitoring of their utilization. However, Italy’s “National Plan for Preparedness and Response to an Influenza Pandemic” establishes five phases of pandemic response measures, with the latter phases transferring the responsibility of distributing PPE stock to the regions. This document, while not legally binding, was used as the basis to respond the COVID-19 pandemic.
A report published by Italy’s National Health Institute (ISS) entitled, “Ongoing recommendations for a rational use of PPE in the management of the Sars-Cov-2 infection, within health and social services (assistance to subjects affected by COVID-19) during current Sars-Cov-2 emergency scenario” lists the PPE needed in the ambulatory setting. Italy’s influenza pandemic preparedness plan referenced above also underlines the steps to guarantee a national storage of PPE. However, it does not distinguish between ambulatory and hospital settings.
In the Netherlands, the centralized distribution system for PPE initially excluded ambulatory providers
The Netherlands has not yet introduced regulations requiring ambulatory health care providers to stock PPE. At the beginning of the COVID-19 crisis, the Netherlands implemented a central system that facilitates distribution of PPE. The Regional Consultative Body for Acute Care (Regionaal Overleg Acute Zorg) assesses the demand for PPE at the regional level, which are aggregated every day to create an overview at the national level. The National Consortium Assistive Devices (Landelijk Consortium Hulpmiddelen) manages the physical distribution of the available resources. Initially, ambulatory care providers were excluded from the distribution system, which was targeted at supplying sufficient PPE to the hospitals. Only after about two months, the distribution system incorporated nursing homes and home care nurses. This has been cited as one of the causes of the large number of COVID-19 cases in nursing homes in the Netherlands.
Regional governments are responsible for buying PPE and managing the stock in Spain
Having a sufficient available stock of PPE in Spain has become one of the criteria for regions to progress towards the different stages of the transition period (or to return to a previous stage), as part of the set of health system response indicators. However, there is no distinction between PPE for ambulatory and hospital care. Since the COVID-19 crisis, autonomous communities (ACs) are responsible for maintaining a strategic reserve with five weeks of secured supply. In order to procure PPE, ACs have to report to the Ministry of Health on a weekly basis about their current stock as well as which percentage of consumption they can cover with their own purchase and which percentage will need reinforcement from the Ministry of Health. This strategic stock would cover all health care levels: primary care, ambulatory care and hospital care.
Even though in many countries individual providers hold responsibility for stocking PPE, the pre-existing incentives and distribution channels ultimately determine PPE availability
While the obligation to have an appropriate stock of PPE can be the responsibility of employers or individual health care providers (e.g. Denmark, France, Germany, the Netherlands), it is most often being coordinated at higher levels, either centralized (e.g., Denmark) or regionalized (e.g. Germany, Italy, Spain). Generally, no financial incentives are provided to ambulatory care providers to keep a stock of PPE (e.g. France, Denmark). However, in the case of France, since 11 May 2020, authorized pharmacists receive a specific payment from the national health insurance fund to manage the stock of sanitary masks for assuring the provision for health professionals and specific patient groups.
In Germany, the federal government delivers PPE to the federal states and the Regional Associations of Statutory Physicians who are responsible for allocating and distributing the material to health care providers. Each region has its own process for distributing PPE; for example, some regional associations distribute PPE themselves via logistics partners while other regional associations distributes PPE to the local/county level to give to the physicians within their domain.
Denmark similarly organizes distribution of PPE on a decentralized basis and prior to the COVID-19 pandemic both regions and municipalities distributed PPE to ambulatory care providers. In March, the Danish authorities decided to prioritize the regions (over municipalities) in terms of PPE. Since 1 April, the regions have had open stock lists so it is easier for them to help each other and ensure that no region runs out of PPE. In order to ensure a continuous overview of the supply situation, municipalities and regions must regularly submit information on the stock status and expected daily consumption of protective products and disinfectants to a database under the Danish Medicines Agency.
Summary and Policy Implications
In six the countries surveyed here, most do not have regulatory obligations for ambulatory care providers to stock PPE themselves (e.g. Germany, the Netherlands), or they are not well defined (e.g. Denmark, France). In the case of Italy and Spain, there is no distinction for PPE stockpiling regulation between ambulatory and hospital care. However, any implementation of regulatory obligations would be difficult to adhere to due to the ongoing shortages of PPE worldwide.
Following the first wave of COVID-19, some countries have shifted to a centralized approach (e.g. the Netherlands has implemented a centralized system to distribute PPE; Denmark has created an Agency that will manage the PPE stock from August onwards), while other countries will continue relying on a decentralized approach (e.g. regions in charge of PPE stock in Spain; Italian local health authorities responsible for surveillance and monitoring of PPE utilization). Hence, it can be seen that PPE is being managed at higher levels (whether centralized or regionalized), even when providers have to pay for PPE themselves.
The patchwork of buyers has created a situation where providers and health systems competed against each other to source limited supplies of PPE. Initiatives that provide an overview of the PPE situation in the country (e.g. Denmark, the Netherlands, Spain) can support supply and redistribution of PPE. Collective actions, such as the voluntary European Commission Joint Procurement Agreement, also have the opportunity to facilitate this procurement and support a more equitable distribution of PPE. As of this post, the European Commission launched five calls for tenders between 28 February and 17 June, with participation from 26 countries. Similarly, temporary provisions between health care stakeholders during crisis periods, such as the PPE stocking agreement in Germany between sickness funds and physicians, can enable distribution groups to act with more speed and flexibility. However, as long as individual providers have the responsibility for their own stocks, equity -that is, the distribution of the PPE supply where it is needed most- cannot be assured.
Erin Webb, Cristina Hernández-Quevedo, and Giada Scarpetti, with contributions from Hans Okkels Birk, Signe Smith Jervelund, Allan Krasnik, Karsten Vrangbæk (Denmark); Coralie Grandre and Zeynep Or (France); Antonio Gulio de Belvis, Giovanni Fattore, Alisha Morsella, Andrea Poscia, Walter Ricciardi, Andrea Silenzi (Italy); Madelon Kroneman (The Netherlands); Juliane Winkelmann (Germany); Enrique Bernal, Ester Angulo and Francisco Estupiñán (Spain).