Reinforced role for European Medicines Agency in crisis preparedness and management for medicinal products and medical devices

1.4.22: The European Medicines Agency (EMA) is today holding a workshop to inform stakeholders of the regulation reinforcing the EMA’s role in crisis preparedness and management for medicines and medical devices [REGULATION (EU) 2022/123 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL]. 

The new regulation was triggered largely in response to the COVID-19 pandemic ie a civil crisis to aim for better readiness to anticipate and respond to public health emergencies. It is clearly also relevant to shortages arising from conflicts such as related to Russia’s war against the Ukraine and the resulting mass migration.

This new Regulation [EU – 2020/123] of 25^th January 2022 was determined to be effective from the date of its publication in the Official Journal of the European Union – 31^st January 2022 and in practice applicable from 1^st March 2022 for the monitoring and mitigation of shortages of critical medicinal products. The EMA is already starting preparatory work with the aim of delivery the European Shortages Monitoring Platform in early 2025.

Success will depend on clear allocation of tasks and responsibilities. High level aims are improved, co-ordinated ways to identify shortages – including mapping surges in demand, streamline processes, remove barriers and enhance preparedness so that when issues arise the EMA and its partner agencies can react in the quickest way possible, within the spirit of the Charter of Fundamental Rights of the European Union that the Union is to “ensure a high level of human health protection in the definition and implementation of all Union policies and activities.”

The Regulation covers the following topics:

• Monitoring and mitigating shortages of medicines and devices
• Addressing public health emergencies through the Emergency Task Force (ETF)
• Coordinating expert panels on high-risk medical devices and in vitro diagnostics

The event provided an opportunity for the public and stakeholders to inform EMA of their needs, expectations and to discuss opportunities for further engagement with the agency.

Key milestones for the EMA include:

1^st March 2022 – start of development of systems re shortages of critical medicines including enhanced IT platforms

2^nd August 2022 – establishing a list of the main therapeutic groups for hospital care

2^nd September 2022 – registration of i-SPOCs (Single Points of Contact) from Marketing Authorisation Holders

2^nd February 2023 – development of systems re shortages of medical devices/in-vitro diagnostics

2^nd February 2025 – European Shortages Monitoring Platform “goes live”

The following are brief notes on the background and high level actions defined within the new Regulation.

 

The COVID-19 pandemic has highlighted the interconnectedness of human and animal ecosystems with regard to risks to health including two-thirds of new diseases and most pandemics from influenza to COVID-19. New risks include effects of changes in land use, new agricultural methods, wildlife trafficking and changes in food consumption.

“… as stated in Regulation (EU) 2021/522 of the European Parliament and of the Council (4), ‘human health is connected to animal health and to the environment and … actions to tackle threats to health must take into account those three dimensions’”.

Experience of the COVID-19 pandemic has highlighted lack of readiness  of the European Union and its Member States to addressing major public health emergencies. The EU has been “severely impeded by the absence of a clearly defined legal framework for managing its response to pandemics and by the limited mandates and resources of its health agencies, as well as by the limited degree of Union and Member States preparedness for public health emergencies that impact a majority of the Member States.”

“Shortages of medicinal products and medical devices have different and complex root causes which need to be further mapped, understood and analysed together with the different stakeholders in order to be comprehensively addressed. A better understanding of those shortages should include identification of vulnerabilities in the supply chain. In the specific case of the COVID-19 pandemic, the shortage of treatments for the disease had a variety of causes, ranging from production difficulties in third countries to logistical or production difficulties within the Union, where the shortage of vaccines was due to inadequate manufacturing capacity.”

Disruptions to supply chains for medicinal products and medical devices include “national export restrictions and bans, border closures impeding the free movement of such goods, uncertainty related to the supply for and demand of such goods in the context of the COVID-19 pandemic, and the lack of production in the Union of certain medicinal products or active substances…”.

Further challenges include “…increased risk of exposure to falsified medicinal products, medication errors, adverse effects resulting from the substitution of unavailable medicinal products with alternative ones, significant psychological distress for patients and increased costs for healthcare systems. … Member States competing with each other when they respond to the legitimate needs of their citizens, thereby contributing to uncoordinated actions at national level, such as national hoarding and stockpiling.”

“In order to facilitate the prevention, monitoring and reporting of shortages of medicinal products, the Agency should set up an information technology (IT) platform, to be known as the European shortages monitoring platform (‘ESMP’), that is capable of processing information on the supply of and demand for critical medicinal products during public health emergencies or major events and, outside of those situations, to allow for reporting on shortages of medicinal products that are likely to lead to public health emergencies or major events.”

Medicine Shortages Steering Group – MSSG
This executive steering group is to be established within the Agency to ensure robust responses to major public health events and coordinate urgent actions within the Union.
The MSSG is to establish lists of critical medicinal products (CMPs), to ensure monitoring of CMPs and provide advice and recommendations on the actions to safeguard the quality, safety and efficacy and supply of CMPs.

Emergency Task Force – ETF
This new ETF is to provide advice on scientific questions related to the development of treatments and vaccines and on clinical trial protocols free of charge to entities involved in their development, such as marketing authorisation holders, clinical trial sponsors, public health bodies, and academia.

Medical Device Shortages Steering Group – MDSSG
This new Steering Group is to coordinate urgent actions within the Union in relation to the management of supply and demand issues of medical devices, and to establish a list of critical medical devices in the case of a public health emergency.

Robust transparency measures and standards are needed regarding the EMA’ Agency’s regulatory activities in relation to medicinal products and medical devices relevant to this Regulation.

European database on medical devices (Eudamed)
Rapid access to and exchanges of health data, including real world data will be needed and should be part of the interoperable European Health Data Space. Provision should be made for setting up and managing new IT infrastructures and their synergy with other existing IT systems and IT systems under development, including Eudamed and for enhanced protection of data infrastructure from possible cyber attacks.

Cooperation with European Centre for Disease Prevention and Control (‘ECDC’) During public health emergencies or major events, the Agency should ensure cooperation with the ECDC including the sharing of data, regular communication at an executive level e.g. re meetings of the ETF, the MSSG and the MDSSG.

Donald Singer
EACPT Delegate
EMA Healthcare Professionals Working Party

 

 

EMA relocation from London to Amsterdam

The European Medicines Agencies' Human Scientific Committees' Working Parties met in London with working parties for  Patients’ and Consumers’ Organisations (PCWP) and  Healthcare Professionals’ Organisations (HCPWP) for the last time in September 2018. These working parties have been meeting regularly in London for the last 5 years to share progress and expertise. From March 2019, the EMA will relocate to Amsterdam - its top priority business continuity for regulation and pharmacovigilance of medicinal products.

A key topic discussed was risk to disruption to the supply chain for centrally authorised medicinal products. 

Reasons:
- supply from the UK
- companies will have to make changes to their marketing authorizations for an EU without the UK.
A MAH may have to move from the UK to another country in the new EU. That may lead to a delay in production of relevant medicines.
Changes at the latest by December 2020.

Options – where available – include switching patients to other medicines with similar efficay and safety profiles. Additional burden of falsified medicines regulations coming at a difficult time.
Other topics included updates on electronic prescribing information, progress of the joint working parties topic group on Digital Media for Health. 

Regulatory support for development of orphan medicines: virtual workshop from the European Medicines Agency

A live online event from the European Medicines Agency on 30 November combined short talks with Q & A sessions and was intended to encourage early and efficient interactions with  regulators by highlighting pre-marketing support in medicine development for treating rare diseases.

The meeting aimed in particular to explain existing tools relevant to early product development strategy. 

These include:​

• orphan designation;
• protocol assistance;
• the PRIority MEdicines (PRIME) scheme.

Stakeholders were given an opportunity to express their views in relation to early medicine development and regulatory interactions. ​

The workshop was targeted at small to medium enterprise medicine developers, academia, patients, healthcare professionals and European Reference Networks (ERNs), often at the forefront of medicine development to treat rare and neglected diseases.

High level points include:

There are estimated to be 6-8000 orphan conditions of which around half concern diseases with an incidence of less than 1 in 10000.

183 orphan medical products have been registered in the EU since 2000. ~120 of these have active orphan status for treating ~130 orphan diseases ie several have indications for treating more than one disease.

Around 2 in 3 orphan products are based on conventional chemical treatments and 1 in 3 involve advanced therapeutic approaches.

The EMA supports SMEs and Academia in orphan drug development through a dedicated contact point, regulatory, administrative and procedural support and engaging with EU bodies and industry stakeholders.

Of the ~2000 SMEs registered with the EMA, 23% are working on orphan medical products.

A video recording will be available after the event on the EMA website.

Raising awareness to combat antimicrobial resistance: European Antibiotic Awareness Day

European Antibiotic Awareness Day EAAD was held on 18 November 2020 with activities taking place during that week. As in previous years, the European Medicines Agency (EMA) actively contributed to raising awareness about Antimicrobial Resistance (AMR) and how to limit it by publishing a set of infocards, developed to reinforce global cooperation to combat AMR.

EAAD is an annual European Union initiative to raise awareness of antimicrobial resistance as an increasing global public health threat and to promote the prudent use of antibiotics.

‘Tackling antimicrobial resistance is a global challenge and a high priority for EMA and the European medicines regulatory network. We all have a role to play in addressing this challenge: regulators, governments, companies through development of new innovative antibiotics, but also healthcare professionals and patients by making sure they prescribe and use antibiotics wisely and responsibly’ said Emer Cooke, EMA’s Executive Director.

To mark EAAD, the EMA launched a social media campaign to highlight the importance of using antibiotics prudently.

A set of info-cards focuses on what patients, healthcare professionals, veterinarians, health-leaders, journalists and the pharmaceutical industry in their respective roles can do on a daily basis to make sure that these important medicines are used wisely.

Antimicrobial resistance occurs when bacteria and other microorganisms change over time and develop resistance to medicines. As a result, antibiotics and other antimicrobial medicines become less effective. This makes infections harder and harder to treat. A prudent use of antibiotics helps slow the process and ensure that treatments continue to be available to treat common and emerging infectious diseases.

For more information on the EMA’s role in the global response to antimicrobial resistance, see Antimicrobial resistance.

You can see examples of the cards below. The full set of these infocards is downloadable on this link. 

 

 

European Medicines Agency to hold a public update on COVID-19 vaccines on 11 December

EMA will organise a public meeting on 11 December 2020 to inform European citizens about the EU regulatory processes for the approval of COVID-19 vaccines and the Agency’s role in their development, evaluation, approval and safety monitoring.

The COVID-19 pandemic is an unprecedented global crisis, with devastating health, social and economic impact. Safe and effective vaccines for COVID-19 are urgently needed to respond to this crisis and reduce its effects.

Together with the European medicines regulatory network, EMA is supporting the development of COVID-19 vaccines and has taken steps to speed up the evaluation processes for these vaccines. The Agency and its partners are doing so while ensuring that the same high regulatory standards for quality, safety and efficacy are being applied to COVID-19 vaccines.

The public meeting will inform citizens about EMA’s role in the pandemic and of EU regulatory procedures. It will also give the opportunity to the public and stakeholder groups to speak and share their needs, expectations and any concerns, that will be considered by EMA and the European medicines regulatory network in the decision-making process.

The EMA will publish the list of speakers who will make an intervention in advance of the event.

The public meeting will be broadcast live and will be open to all citizens. In addition to the selected list of speakers, during the meeting there will be a mailbox open via EMA’s website for the public to make comments.

The agenda and all information related to the event are available on the EMA website event page.

Please check EMA’s dedicated webpage on COVID-19 for the latest updates.

Updates from the European Medicines Agency re Covid-19: advice to continue use of ACE inhibitors and ARBs

27.3.20: Briefing from the European Medicines Agency

EMA reports that it is aware of recent media reports and publications which question whether some medicines, for instance angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs, or sartan medicines), could worsen coronavirus disease (COVID-19). ACE inhibitors and ARBs are most commonly used for treating patients with high blood pressure, heart failure or kidney disease. 

The EMA has providing the following advice from its Public and Stakeholders Engagement Department.

"It is important that patients do not interrupt their treatment with ACE inhibitors or ARBs and there is no need to switch to other medicines. There is currently no evidence from clinical or epidemiological studies that establishes a link between ACE inhibitors or ARBs and the worsening of COVID-19. Experts in the treatment of heart and blood pressure disorders, including the European Society of Cardiology, have already issued statements along those lines. To gather more evidence, EMA is proactively reaching out to researchers working to generate further evidence in epidemiological studies.

As the public health crisis rapidly extends across the globe, scientific research is ongoing to understand how the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reproduces in the body, interacts with the immune system and causes disease, and whether ongoing treatment with medicines such as ACE-inhibitors and ARBs could impact the prognosis of COVID-19.

The speculation that ACE-inhibitors or ARBs treatment can make infections worse in the context of COVID-19 is not supported by clinical evidence. These medicines work by affecting the renin-angiotensin-aldosterone system (RAAS). Because the virus uses a target called angiotensin converting enzyme 2 (ACE2), which is part of this system, to enter human cells, and the medicines can increase ACE2, one of the suggestions among others is that they could also increase virus activity. However, the interactions of the virus with the RAAS in the body are complex and not completely understood.

EMA is monitoring the situation closely and is collaborating with stakeholders to coordinate epidemiological studies on the effects of ACE inhibitors and ARBs in people with COVID-19.

EMA is helping to coordinate urgent ongoing research and is fully committed to keep the public up to date with any development in this field. EMA is also aware of reports questioning whether other medicines such as corticosteroids and non-steroidal anti-inflammatories (NSAIDs) could worsen COVID-19, and has recently issued a communication on NSAIDs medicines. It is important that patients who have any questions or are uncertain about their medicines speak to their doctor or pharmacist and do not stop their regular treatment without speaking to their healthcare professional first.

Medicines should be prescribed and used in line with clinical judgement, taking due note of any warnings and other information provided in the summary of product characteristics (SmPC) and thepackage leaflet, as well as guidance issued by the WHO and relevant national and international bodies.

Within the EU medicines regulatory network, evidence on the safe use of medicines is reviewed as it emerges. Any new advice that arises is disseminated appropriately through EMA and national competent authorities.

EMA will provide further information as appropriate.

This information and related content are published here. Please check EMA’s dedicated webpage on COVID-19 for the latest updates."

Updates from the European Medicines Agency: from vaccines to repurposing medicines and pharmacovigilance

24th-25th September
The European  Medicines Agency has hosted its first meetings in Amsterdam  for its Healthcare Professional Working Party and Patient and Consumers Working Party since the move of the Agency from its former Canary Wharf headquarters in London. The sessions coincided with the launch of a further three year work programme agreed between the EMA and its working parties.

Papers from the meetings will be available on the EMA website. 

Key themes in the new work programme will include secure supply of medicines, digital media for health, public health strategy on antibiotic resistance, addressing vaccine hesitancy, early access to medicines, pharmacovigilance, and encouraging patient engagement.

Central Amsterdam

Major topics discussed during the current Amsterdam meetings included initiatives to address vaccine hesitancy, updates on pharmacovigilance and initiatives on repurposing of medicines. In addition, the EMA provided updates from its major standing committees, including the Committee for Orphan Medicinal Products (COMP), Pharmacovigilance Risk Assessment Committee (PRAC), Committee for Advanced Therapies (CAT), Committee for Medicinal Products for Human Use (CHMP), Paediatric Committee (PDCO) and Committee on Herbal Medicinal Products (HMPC).

Isabel de la Mata, Principal Advisor on Public Health and Crisis Management at the European Commission discussed current initiatives to address vaccine hesitancy, an early priority of EU President-elect Ursula van der Leyer.

De la Mata noted that vaccine coverage is below 95% in many EU member states. A 2019 Eurobarometer on vaccine confidence had highlighted several key points of misinformation, for example with 48% of respondents thinking that vaccines often produce serious side effects, 38% that vaccines can cause the disease they prevent and 55% considering that vaccines overload and weaken the immune system.

A Global Vaccination Summit had been held on 12^th September with around 400 delegates political, technical, patients and other - and with WHO collaboration. This led to a 10 point document including new focus on reliable access to vaccines, safety and transparent, clear, independent information.

Actions by member states are to include developing national and regional plans, better access to vaccines, increased public health communications, more training of health professionals, accurate digital information on vaccination status and increased support for vaccine research and innovation.

European level actions are to include a new European Vaccination portal coordinated by ECDC (European Centre for Disease Control) with support from the EMA (EVIS - European Vaccine Information Sharing). Other work will consider dissemination of vaccine schedules, focus on the supply chain, including mitigating shortages and identifying and overcoming barriers to access.

A new coalition of healthcare workers for vaccination, launched on 5^th March in Brussels, aims to address and reverse reasons for outbreaks of measles and other vaccine-preventable infections in health workers as recently as 2017 and 2018, with transmission in the healthcare setting even in countries with high vaccination coverage.

John Kinsman, Expert in Social and Behavioural Change Communication at the ECDC, outlined Development of the European Vaccination information Portal. This is due to be piloted in December 2019 and launched in April 2020 during European Immunisation week.

The portal has a legal basis, arising from a 2016 European Commission call for the ECDC to work with EMA to develop the portal.  Issues include the reality that the majority of the public do not have a scientific background and making sure through content, language and accessibility that the portal is as widely available as possible.

The EMA is seeing an exponential increase in reporting by patients of suspected adverse drug reactions.  A pressing aim of the EMA is how best to learn from patient reporting of possible ADR. This will benefit from previous experience of patient reporting to national competent authorities  (e.g. US FDA and UK MHRA [patient reporting since September 2005]) and international agencies (e.g. the WHO Uppsala Monitoring Centre).

Plans for future meetings include proposals for further discussion of initiatives on vaccine uptake.