1 What is Personal Protective Equipment?
Personal Protective Equipment, or PPE for short, is an umbrella term for products that can be worn or held, to protect against COVID-19. Such equipment is crucial for controlling the spread of the coronavirus pandemic – and in various member states, the wearing of PPEs, such as masks, is obligatory, together with social distancing regulations. PPE is especially critical for healthcare workers, considering that they cannot practise social distancing when seeing patients.
2 What EU legal frameworks are applicable?
A majority of the products used in the context of the current health crisis, including FFP-type (filtering facepiece) masks, are considered as PPE and hence fall under the scope of Regulation (EU) 2016/425 on personal protective equipment. Other products such as medical gloves, surgical masks, intensive care and other medical equipment are products falling within the scope of the EU legal framework on medical devices – Council Directive 93/42/EEC, that was to be replaced by Regulation (EU) 2017/745 as of May 2020.
However, in order to prevent shortages or delays in getting key medical devices on the market, Parliament decided to postpone the application of the Medical Devices Regulation, and the new medical devices regulation will be applicable from May 2021, allowing the prioritisation of the fight against COVID-19.
Each of the two legal frameworks fully harmonises the performance requirements for the products that it covers in order to ensure protection of the health and safety of users. Thus, products manufactured in accordance with these rules can circulate freely throughout the internal market, and member states may not introduce additional and diverging requirements regarding the manufacturing and placement on the market of such products. The full regulations are available to download here.
3 Are there mandatory EU standards to produce protective equipment?
Both the PPE Regulation and the Directive on Medical Devices lay down essential requirements on health, safety and performance of the products they cover. However, both EU legal frameworks are technologically neutral and do not prescribe any specific mandatory technical solutions for the design of the products. Therefore, a number of technical solutions may be used by manufacturers to meet these essential requirements.
Both the PPE Regulation and the Directive on Medical Devices offer the possibility for manufacturers to rely on specific technical solutions. The references of these harmonised standards have been published in the Official Journal of the European Union. Where a manufacturer chooses to adopt such a technical solution, the product is presumed to be in conformity with the applicable essential health, safety and performance requirements.
4 Preparing for the unknown
The swift manner in which the COVID-19 crisis progressed – together with the unknowns it heralded – highlighted the world’s low state of readiness. This meant healthcare systems were confronted with a crisis on a massive scale.
On March 11, the World Health Organisation declared COVID-19 a global pandemic, and two days later, the WHO said Europe had become the epicenter of the pandemic.
In a Reuters report published on March 25, it was claimed that member states needed 10 times as much PPE and other medical equipment, than traditional supply chains could provide.
Given the shortage of PPE, the Commission launched four joint procurements with member states to facilitate and accelerate the procurement process for medical equipment.
Nurse and patient in the EP's Strasbourg building, currently functioning as a COVID-19 testing centre. Photo: European Union
5 Joint procurement
The Commission launched four different calls for tender for PPE and medical equipment for joint procurement by member states: on February 28 for hand and body protection; on March 17 for face masks, gloves, goggles, face-shields, surgical masks, overalls and a second call for ventilators and respiratory equipment; and on March 19 for laboratory equipment including testing kits. According to the Financial Times, the total value of PPE was about €1.5bn . The initiative was a deemed a success by the EC, with 25 member states participating. The equipment was to be made available two weeks - with flexibility for different production and transportation times – after the member states signed the contracts with the bidders.
Malta requested over two million pieces of PPE as part of the EU’s joint procurement procedures.
6 EU’s role in boosting supply and distribution of PPE
In normal circumstances, harmonised standards – that is, technical specifications used by industry to ensure compliance with the necessary safety requirements – are purchased from national members of the European standardisation organisations and their use is restricted by IPR rules.
However, in the midst of the COVID-19 crisis, on March 20, the European Commission put in an urgent request to the European Committee for Standardisation – CEN – and to make all relevant European harmonised standards freely and fully available to increase European production capacity of PPE.
The EU in March moved to ensure adequacy of supply of PPE in the EU to combat the coronavirus by requiring that exports of such equipment outside of the EU be subject to an export authorisation by member states. The export authorisation scheme was then revised to reduce the list of products that require export authorisation to masks, spectacles and protective garments, extend the geographical exception (including to the Western Balkans), and to require member states to swiftly grant authorisations for exports for humanitarian purposes.
7 Increasing manufacturing
The EU implemented various measures to encourage EU operators to redesign their supply chains to start producing PPE. These measures include: support measures to increase the capacity of existing EU manufacturing facilities; reaching out to companies that are not active in the EU market; and publishing guidance for manufacturers to help them assess whether they can convert their existing facilities to produce PPE. This means that production lines from other sectors – including textile and automotive – were converted to produce PPE, thus boosting member states’ availability.
On May 12, the Commission gave the go-ahead, under state aid rules, to Malta to invest up to €11.5 million to support the production of vaccines, ventilators and PPE. The scheme was open to all enterprises in all sectors capable of increasing the production of coronavirus-related products or of diversifying its production to produce and manufacture such products.
8 Vital supply within the Single Market
In order to ensure the transport of essential goods and vital medical and protective equipment – including PPE – on March 23, guidelines were issued to ensure speedy flow of goods across the EU and avoid bottlenecks at key border crossing points. EU transport ministers supported the setting up of green lane supply routes. Procedures at green lane border crossings were also minimised to what is strictly necessary – an effort that highlighted enhanced cooperation among EU member states.
This was an essential move within the EU. As the chair of the European Parliament’s Internal Market Committee, and medical doctor, Petra de Sutter put it, “Completely closing down borders might seem like the safest way to protect our citizens, but we all depend on imports from other member states to keep our supplies uninterrupted. Guaranteeing the unobstructed transport of essential goods such as food and guaranteeing an uninterrupted supply of vital medical and protective equipment, ensures that this crisis will not turn into a catastrophe. We rely and we depend on each other when it comes to our public health”.
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