The efforts of the Self-Care Industry in a time of need
During the COVID-19 pandemic, health systems face an unprecedented number of patients requiring urgent care. There are increased challenges in healthcare, as material and human resources are scarce for the peaking demand. Optimizing the availability of healthcare professionals, infrastructure, equipment and therapeutics is essential in a time of need, so that dire choices don’t have to be made in the future.
Individual voluntary confinement, hand and respiratory hygiene as well as self-managing mild symptoms will help to relieve pressure on healthcare units and, as a consequence, distribute the need for acute severe treatments in a longer time span.
The responsible use of self-care products allows for the relief of symptoms associated with cold and flu, which are also common to COVID-19. It is important that citizens are ensured regular access to self-care products, such as non-prescription medicines, medical devices and food supplements, through their regular suppliers (e.g. pharmacies). It is likewise important to convey a message of trust in the continuity of the supply chain, so that distortions in consumption are not induced due to, for instance, unnecessary stockpiling.
Some countries around the globe struggle to halt viral transmission and impose measures that impact transports and borders. This, in turn, can adversely affect the international safe-passage of essential goods, such as medicinal ingredients, medicines, medical devices, hygiene products or protective equipment.
As the situation is evolving very rapidly, European self-care industries prioritized the continuity of their supply chains to ensure that stock provisions of self-care products are not interrupted.
AESGP works with the European Commission and the European network of medicines and medical devices regulators
AESGP is working alongside other European pharmaceutical and medical devices industries to inform, predict and resolve eventual problems to make sure that any potential shortages are prevented and/or mitigated.
AESGP believes that only through a coordinated approach of manufacturers, suppliers, governments and executive agencies, will it be possible to overcome this crisis with better and faster positive outcomes.
Dialogue with the European Commission
On a weekly basis, AESGP and other trade associations representing manufacturers of medicines, vaccines and medical devices have joint meetings with the European Commissioners for Health, Stella Kyriakides, and for Internal Market, Thierry Breton, also in the presence of the European Medicines Agency and other European official bodies when deemed necessary (e.g. ECDC, DG SANTE or DG ECHO). These meetings are important in order to forecast potential problems that might need political solutions or diplomatic intervention at EU level.
In these meetings, the European umbrella associations provide information on the stability of the supply chain, both inside the EU and reliance on third country supply. These stakeholders also describe actual problematic episodes and suggest viable actions for the European Commission. In turn, the European Commissioners expand on their concerns for healthcare provisions across Europe and their political efforts to ensure that Member States act in a coordinated manner and have enough tools to properly address the pandemic challenges.
This has been the right forum to discuss, for example, green lanes for cross-border delivery of essential healthcare goods, or to ensure that protective equipment is available also for workers of medicines and medical devices manufacturing plants. As the situation evolves, other problems will most surely come up and they will be addressed in these meetings, such as the special demand for certain healthcare products. It is also of particular concern that regulatory processes foster timely access to the market, without delays from regulators and actors of the regulatory system, even if predicted derogations need to be applied temporarily, upholding public health interest.
Dialogue with the European medicines regulatory network
In addition, the EMA, the European Commission and the national competent authorities of the Member States have set up the EU Executive Steering Group on Shortages of Medicines Caused by Major Events to discuss measures aimed at addressing the impact of the outbreak of COVID-19 on the supply of medicines in the EU.
The Steering Group has requested AESGP and other EU pharmaceutical industry associations to raise awareness among their members of the potential impact of quarantine measures in China and elsewhere on the supply of medicines in the European Economic Area (EEA) and remind them of their obligation to report any possible shortages to the EU authorities.
AESGP is also asking its member companies to report the preparedness to prevent possible shortages that may result from the outbreak and report back to the Steering Group. Industry associations including AESGP have indicated that no specific disruptions have yet been identified and that any impact in the short-term would be limited, given the current stocks in place.
However, supply issues can be expected if lockdowns continue and/or other disruptions occur (e.g. caused by individual stock-piling, logistical problems or export restrictions). Therefore, continuous dialogue between Industry and the European medicines regulatory network is required in order to find viable solutions to safeguard supply of pharmaceuticals.
Dialogue with the European medical devices regulatory network
The European Commission, in close collaboration with Member States’ competent authorities and relevant economic operators, has been working on setting up a joint procurement mechanism for Personal Protection Equipment (PPE) and some essential medical devices. Together, these stakeholders are also assessing the impact of this rapidly developing situation on the smooth implementation of the Joint Implementation Plan, always bearing in mind that the common objective is to ensure the availability of safe and critical devices for healthcare professionals and patients in the EU.
AESGP is continuously collecting the feedback from its member companies regarding the impacts of the COVID-19 crisis on the implementation of the Medical Devices Regulation (MDR), as well as for the certification and availability of medical devices in Europe, and reporting these issues back to the Commission.
Similar to medicines, supply challenges can be expected to grow if lockdowns continue and/or if any disruptions occur. To be able to sort out viable solutions to protect medical devices supply, it is vital to ensure constant dialogue between Industry and the European network of regulators.
Industry associations, including AESGP, have indicated that companies are currently investing all their efforts in maintaining the continuity of medical devices supply to face the current worldwide challenges. At this point in time, these companies cannot prioritise the implementation of the new Medical Devices Regulation, due to apply from 26 May 2020. AESGP is therefore calling the European institutions and the network of medical devices regulators for a pragmatic and coordinated approach to ensure the continuity of the devices supply. Once the situation has stabilized, all actors of the medical devices regulatory system can again dedicate the resources needed to properly implement the new Regulations in a manageable way.
AESGP in close contact with its members: addressing shortcomings and sourcing solutions
To prepare for the exchanges with the Commission and EMA, AESGP coordinates daily with the national industry associations and European level companies in direct membership to proactively collect relevant information and share it as fast as possible.
AESGP is in close contact with its members to facilitate the early reporting of supply bottlenecks which could potentially affect healthcare products’ availability in Europe, and to find pragmatic solutions together with legislators and regulators.
Self-care options have a large range of offer in a stable market
The market for self-care products remains competitive, with more than 2.000 companies supplying the needs of European citizens. The range of offer is therefore maximized, with numerous therapeutic options and number of well-established brands to choose from. This makes it harder for any eventual shortage to translate into a direct impact to the European citizens or to hinder their access to self-care choices.
AESGP did not stop working, while ensuring safety of staff
In order to safeguard the health and well-being of its team and commit to sanitary regulations, AESGP has moved to a fully remote operational model, with the team working from home. The exceptional measures will however not sacrifice the needs of the members nor the institutional demands of the occasion (see Covid-19: AESGP continuity planning).
These measures will be revised frequently and in line with Belgian authorities’ recommendations.
 EFPIA, Vaccines Europe, Medicines for Europe, COCIR, MedTech Europe