- Feb 26 Blog Post: HERA – Just another new EU agency?
Last January, the European Commission launched the consultation on the European Health Emergency Preparedness and Response Authority, HERA for short.
How can we make sure this new agency finds its way? Clarity on its roles and responsibilities will be needed.
See our take in this new blog post: https://blog.eucope.org/2021/hera-closer-coordination-in-the-eu-against-covid-19/
- Jan 28 Artificial Intelligence in Health: A European Opportunity
As demonstrated by the fight against COVID-19, Artificial Intelligence (AI) has the potential to drive change and improve efficiency and accessibility in healthcare.
From compounds design in medicines development to faster patient screening and diagnosis to hospital management (to name but a few applications), AI-based solutions can help upgrade our healthcare systems towards more sustainability, while helping to address patients’ unmet needs. AI represents a historic opportunity to redesign healthcare in Europe, but realizing its full potential will require some structural, behavioural and societal adjustments.
In its White Paper on AI in Health, EUCOPE and its members of the Digital Task Force put forward concrete recommendations to address the main challenges in developing AI-based technologies and, so far, impeding the EU’s efforts in leading innovation in that regards.
- data challenges (quality, access, disparity)
- regulatory barriers (validation process, international cooperation)
- organisational and social challenges (access to skills, funds and public trust)
Important hurdles remain for the EU to lead this race (data challenges, clear guidance on quality requirements for validation processes), but the plans from the European Commission indicate a strong ambition from policymakers. We believe it is paramount that any upcoming legislative steps act as an accelerator to stimulate innovation, to the benefit of the EU competitiveness, and ultimately, to the benefits of European patients.
- Nov 25 EC Pharmaceutical Strategy – Time for a Modern Approach to Value
EUCOPE, the European association for small to medium-sized companies active in pharmaceuticals and biotechnologies – many of which are researching and developing rare disease treatments – notes the publication of the European Commission Communication on the Pharmaceutical Strategy for Europe.
EUCOPE calls for a comprehensive Pharmaceutical Strategy that adopts a value chain approach, encompassing European manufacturing and sustainable biopharmaceutical innovation leadership.
EUCOPE believes that the proposed implementing measures provide a unique opportunity to deliver on the Strategy’s objectives to ensure the quality and safety of medicines while boosting the sector’s global competitiveness. However, EUCOPE notes a disconnect between the objectives and some of the actions proposed by the Commission.
The EU needs to be effective and result-oriented when implementing the Pharmaceutical Strategy. We call for a balanced approach, opting for a targeted revision of the pharmaceutical legislation. The COVID-19 pandemic has proven that the ‘cost minimisation’ model is more expensive in the long run; instead, the EU needs to foster a ‘value optimisation’ model by integrating the value for patients at the core of the healthcare systems. In the midst of the pandemic, the effort of the European institutions to work together and deliver policy actions in real-time has been unprecedented. COVID-19 demonstrates that a healthy environment for biopharmaceutical innovation is a key element of crisis’ preparedness and response.
The EU incentives environment needs to be strengthened, building on its achievements to date, to sustain investments and planning cycles required to foster research in areas of high unmet needs, as well as to support the delivery of continued innovation where treatments exist. Alexander Natz, EUCOPE Secretary General
We note the European Commission proposals to review pharmaceutical incentives, including the development of more incentives in the rare disease area. EUCOPE is committed to actively contribute to the policy process with concrete ideas and proposals, both as a representative of the small to mid-size biopharmaceutical companies and as a co-lead of the European Expert Group of Orphan Drug Incentives, a multi-stakeholder coalition that brings together the broad rare disease community, working at recommendations to contribute to the Orphan Medicinal Products (OMP) Evaluation.
EUCOPE’s members play a key role in the European pharmaceutical environment. Some of them have unique profiles due to their highly specialised product portfolio, no or limited revenues to date, significant and risky R&D investments, including in OMPs and Advanced Therapy Medicinal Products (ATMPs). These companies invest in R&D extensively and across entire portfolios of products. COVID-19 shed light on the lengthy and complex journey of medicines development, being a magnifying glass of the issues that the rare disease community has long been facing, e.g. lack of awareness on the diseases, evidential uncertainty, scarcity of data and fragmented national regulatory systems.
In light of these hurdles, allocating R&D to a specific treatment and predicting its return of investment is close to impossible. Therefore, linking incentives to these conditions might defy the very objectives of the strategy, both of ensuring patient access and boost competitiveness and innovation in Europe.
We welcome other provisions of the communication including the initiatives on regulatory flexibility and enhancing dialogue and cooperation among regulatory authorities, HTA and national payers. We are also looking forward to seeing more provisions on the EU Health Data Space and other initiatives that support the uptake of real-world evidence which is an effective complementary approach in addressing the benefits and risks of a medicinal product that cannot be sufficiently answered with data from clinical trials.
COVID-19 showcases that European responses to new and emerging health crises do not happen in a vacuum but rather have an important international dimension. In view of this, we welcome the European Commission’s intention to continue ensuring a level playing field and a regulatory environment that is conducive to innovation and competitiveness and building resilient and diversified European supply chains.
- Oct 05 EUCOPE-BIO Webinar: Maintain the innovation ecosystem at all costs
The EU and US Biotech Sector’s Response to COVID-19
On 24 September, EUCOPE, together with BIO, hosted a webinar focusing on the response of the global biotech sector to COVID-19 pandemic as well as measures taken by regulatory and policy institutions in the EU and US. The objective of the webinar was to understand the reaction of the two jurisdictions to the pandemic.
Alexander Natz, EUCOPE Secretary General, kicked off the webinar providing an overview of the European response. He recognised the tremendous work done by the European Institutions and Agencies in providing timely guidance to manage a European coordinated strategy in a global setting.
Looking ahead, a balanced approach and proportional measures will be crucial to guarantee continuity of the work of the biotech and pharmaceutical industry. Before taking any actions, it is essential to look at the lessons learnt in the past months to be well equipped and ready in case of a second wave of the virus.
Joe Diamond, BIO Executive Vice-President for International Affairs, echoed Alexander’s message that an adequate analysis of the effectiveness of the biotech industry requires a global perspective together with global collaboration. Differentiation of the supply chain is a first step that mitigates disruption in case of natural disaster, including pandemic, concluded Joe.
Regulatory flexibility agreed during the health crisis demonstrated to be an effective instrument to guarantee resilience and continuity of care. This should be one of the lessons learnt for responding to future crisis and high unmet medical needs.
“Maintain innovation ecosystem alive to keep the engine of innovation running. If you want innovation you need to support small companies” called together EUCOPE and BIO.
Response by Industry
David Thomas, Vice-President for Industry Research at BIO introduced some slides demonstrating how the most advanced drug programmes are monitored with dynamic and interactive tools highlighting that 72% of unique drug programmes come from smaller companies.
In addition to Dave’s insights, Phyllis Arthur, Vice-President Infectious Diseases and Diagnostics at BIO illustrated the pivotal role played by the World Health Organization (WHO) during the pandemic, as well as the role it will play in the future to ensure that COVID-19 vaccines and treatments will be available to all countries once approved by regulatory Agencies. Public-private cooperation will be essential for achieving successful results.
Coming back to the European landscape, Monica Dias, European Medicines Agency, provided an overview of the actions undertaken from the Agency to mitigate the disruption of the pharmaceutical supply chain and, possibly, prevent any shortages.
The event has been also an opportunity to hear from a company perspective the impact of COVID-19 on the biotech sector. Julien Patris, Alnylam, emphasised that working for innovation in health means working for growth. Instead, cost-containment measures hit disproportionally biotech companies and depressed their growth. A new mindset and bold actions are needed for achieving a sustainable ecosystem.
To conclude, Antoine Jourdan, French Ministry of Economic Affairs, spoke about the new France Relance plan that is expected to increase the resilience of the national and European supply. COVID-19 represents a paradigm shift, simplifying access to market, streamlining processes and access to finance for businesses.
Watch it again!
The video recording of the webinar is available at this link: https://drive.google.com/file/d/1BphtNt0PYcymdPP8OmPr6abu0ihbvoxP/view?usp=sharing
- Sep 07 EUCOPE – BIO Webinar: The EU and US Biotech Sector’s Response to COVID-19
On 24 September, EUCOPE, together with BIO, will host a webinar focused on the response of the global biotech sector to COVID-19 pandemic as well as measures taken by regulatory and policy institutions in the EU and US. The agenda will tackle:
- Measures taken by regulatory and policy institutions in the EU and US, and how they compare between each other;
- EUCOPE COVID-19 priorities and actions;
- BIO’s reaction to the pandemic;
- Impact on the pharmaceutical sector, with experience from a US biotech;
- How can the sector rebound, and an analysis of the potential next steps.
Please register here.
For further information, please contact Laurent Louette.
- Jul 07 EUCOPE response to the EC Pharmaceutical Strategy Roadmap
On the verge of the publication of the EU industrial strategy in March, EUCOPE shared the expectations and ambitions of its membership for a coherent strategy that harness Europe’s untapped potential: small and medium biopharma. The mission letter from President von der Leyen to Commissioner Kyriakides calls for measures supporting the European pharmaceutical industry in remaining an innovator and world leader. EUCOPE awaits for the European Commission to launch a Pharmaceutical Strategy that delivered on these objectives.
With the COVID-19 crisis, the pharmaceutical sector demonstrated the potential for being a driving force for economic recovery and a key factor for healthcare systems’ resilience. Yet EUCOPE notes a disconnect between the identified issues and the actions proposed in the roadmap, which currently lacks concrete plans to promote the EU’s competitiveness, (re)investment in innovative therapies, and incentivise industry in adopting green technologies.
Alexander Natz, EUCOPE’s Secretary-General commented on the Pharmaceutical Strategy Roadmap:
“The EU’s objective of ensuring greater access, availability and affordability should go along with enabling innovation by means of a strong incentive ecosystem. Adaptable yet clearer and faster regulatory pathways will be key to harness the potential of new technologies, such as ATMPs, nanotechnologies and digital applications for medical devices.’’
Indeed, many opportunities can be seized while ensuring synergies with other much needed EU initiatives such as the Green Deal and EU Health Data Space.
EUCOPE welcomes measures to ensure alignment and coordination among Member States on innovation, supply of products, administrative simplification and transparency. We also welcome the Commission’s intention to reinforce the European Medicines Agency via the Next Generation EU instrument, as we believe this will have a positive impact on the efficiency of EU regulatory activities.
Standing ready to engage in the next phases of the Pharmaceutical Strategy consultation process, EUCOPE encourages all stakeholders to make their voice heard in these momentous times.
The full consultation response can be found here.
- May 29 UK Initiative on Rapid Patient Access to COVID-19 Treatments
As part of the collective response to COVID-19, a significant number of clinical trials are underway in an attempt to identify potentially effective COVID-19 treatments and bring them rapidly to patients. The EMA has published guidance documents on EMA initiatives for the acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines
In the UK, NIHR, NICE, NHSE&I and the MHRA have been working closely together under the banner of the RAPID-C19 initiative to support this effort.
RAPID-C19 aims to ensure that there is a rapid, systematic and collective approach to taking promising medicines from those clinical trials through existing processes to enable rapid patient access – the goal being that this coordinated approach will take no longer than ten days from the receipt of the clinical trial evidence for treatments of significant clinical value. The scope of the RAPID-C19 initiative is for new and repurposed medicines that could significantly improve the treatment of COVID-19 patients.
The various steps to coordinate the collective work can be summarised as:
- Collective, proactive identification of clinical trials with significant promise (national and international), led by NIHR and NICE
- Collective prioritisation of timely/promising trials to be collectively fast-tracked, through the Oversight Group, which meets weekly
- Agreeing and then organisationally supporting the appropriate ‘routing’ of priority treatments through existing processes (such as EAMS, NHSE Interim Commissioning policies, licence through MHRA etc.).
It is important to note that the partner organisations are seeking to fast track medicines of promise through the existing process but at pace. As such, the collective RAPID-C19 Oversight Group is NOT acting as a decision-making body but as a project oversight/directing group, ensuring all necessary elements are on track and meet individual organisational (i.e. MHRA) process requirements.
- May 05 COVID-19: EMA accelerates its Regulatory Process
The European Medicines Agency has published an overview of how it will accelerate its regulatory procedures so that the marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible. The rapid procedures will be able to accelerate every step of a medicine’s regulatory pathway.
Faster support in the R&D phase
Scientific Advice: In the context of COVID-19, fees for scientific advice are waived and the procedure is reduced to a maximum of 20 days, compared to normally 40-70 days.
PIPs and compliance checks: The total review time for a paediatric investigation plan (PIP) for COVID-19 products will be reduced to 20 days, compared to normally up to 120 days active review time. In case needed, EMA also carries out a check to ensure companies comply with the agreed measures listed in each PIP before a marketing authorisation can be submitted, which will now also be reduced to 4 days.
EUCOPE welcomes these changes intending to fast-track the development and approval of medicines and vaccines.
- Apr 28 ECDC – Q&A on COVID-19
The European Centre for Disease Control (ECDC) published an interesting list of questions and answers in relation to the COVID-19 pandemic. The Q&A list, available on their website covers many topics from general information, medical information, prevention, to more practical implications concerning the need for travel, the link between the diseases and animals, etc.
In an exchange of letters with the ECDC, EUCOPE flagged to the agency the importance of Member States guidelines on the treatment of vulnerable patients during COVID-19. EUCOPE is happy to see a list of such national guidelines now featured in the Q&A webpage, under the medical information chapter. This only underlines the need for collaboration between all stakeholders and the paramount importance of a coordinated approach when it comes to fighting this unprecedented pandemic.
The document is accessible here.
- Apr 28 EMA Q&A Document on Regulatory Flexibility: Updates on GMP/GDP
The European Commission, EMA and the national competent authorities have agreed on a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the European Union. The measures are detailed in the latest version of the Q&A document.
We want to raise your attention to the following decision: the validity of GMP certificates and time-limited manufacturing and import authorisations, as well as the validity of GDP certificates and time-limited wholesale authorisations will be extended until the end of 2021.
More information is available on the EMA’s website: https://www.ema.europa.eu/en/news/update-guidance-regulatory-expectations-context-covid-19-pandemic
- Apr 21 SME Connect Webinar: Role of SMEs in fighting COVID-19
EUCOPE has been invited to speak at the next webinar organised by SME Connect, to discuss the needs of and important role played by small and medium-sized companies in the fight against COVID-19. EUCOPE will be represented by Alexander Natz, EUCOPE Secretary General.
Other panellists include Christian Ehler, MEP and representatives from other trade associations in Brussels. The webinar will take place on 28 April from 9 to 10am.
More info and register here: https://zoom.us/webinar/register/WN_aB0DjXo7Smqeq9-stU8mCQ
- Apr 14 Q&A Document on Regulatory Expectations during COVID-19
The European Commission, EMA and the European medicines regulatory network have developed a question and answer guidance document on regulatory expectations for medicinal products for human use during the COVID-19 pandemic. You can access the guidance online here https://www.ema.europa.eu/en/news/guidance-regulatory-requirements-context-covid-19-pandemic.
The Q&A document includes information on legal and regulatory guidance on
- MAs/MAs procedures;
- manufacturing and importation of Finish Product and Active pharmaceutical ingredients with an Exceptional Change Management Process (ECMP) being introduced;
- quality variations;
- product information and labelling.
This document is a living document which will be updated as required. EUCOPE will report any comments from its member companies at the weekly calls with the EMA and national authorities on the COVID-19 crisis and its impact on the regulatory environment for medicines in Europe.
- Apr 08 COVID-19: Need for undisrupted access to treatment in hospitals
The COVID-19 pandemic creates an extraordinary situation for all stakeholders. EUCOPE members are particularly concerned with the impact the COVID-19 crisis created on clinical development.
Delay of patients’ access to innovative treatment
The delay caused by the pandemic in drug development is in particular concerning in the area of investigations on unmet medical need and life-threatening diseases.
If nothing is done, we could see a delay in patients’ access to treatment and therapies in hospitals, which could have a detrimental impact. This aspect will be emerging for companies whose specialized therapies are given to patients in hospitals. With hospitals at full capacity and focusing entirely on battling the Coronavirus, we need undisrupted access to treatment and therapies in hospitals.
National divergences in clinical trials
EUCOPE notes that there is a level of divergence at EU level concerning the clinical trial guidance, with different level of pragmatism on how clinical trial sponsors can manage the uncertainty and the conduct that some trials are in. We also notice discrepancies in requirements for deviation management, urgent safety measures, and other contingency planning that requires regulatory actions;
EUCOPE asks EU authorities and national agencies to coordinate as much as possible their requirements and to ensure a harmonized, pragmatic approach across EU Member States. This will facilitate how companies, particularly small & medium enterprises, manage multi-country clinical trials and ensure patient safety is assured
- Apr 08 COVID-19: EUCOPE Calls for more Regulatory Flexibility
Following the recent EMA guidance on clinical trials management during COVID-19, EUCOPE calls the EMA and all national authorities to allow for flexibility in these exceptional times. In addition, EUCOPE recommends the following:
- Standardised Approaches: all stakeholders involved in discussing the COVID-19 response make best efforts to align across Member States as much as possible and to be as pragmatic as possible; European-wide approaches are necessary to ensure there is no increased risk of breaking the integrity of the trial and the data it generates.
- Regulatory Flexibility: Consistent with the spirit of providing the maximum level of regulatory flexibility in the clinical trial guidance, flexibility in adjusted timelines for satisfying regulatory requirements in relation to clinical trials.
- Statistical Issues: Inevitably study participants will not be able to attend clinical sites for follow-up visits, leading to missed data points delayed readouts or missing data. This will lead to necessary changes to statistical plans.
- Global Collaboration and Alignment: Global regulatory authorities should leverage and expand existing regulatory collaboration mechanisms to ensure the safety and rights of participants are not compromised and the integrity of the data from the trial is maintained.
- Innovative Clinical Trial Strategies: Since participant travel to clinical trial sites will be limited during the COVID-19 crisis, EU regulators should encourage innovative approaches to evaluate new medical products, such as through master protocols, adaptive studies, and decentralized trial designs.
- Apr 03 COVID-19: EMA New Guidances on Clinical Trials
The European Medicines Agency (EMA) recently issued a new guidance following the COVID-19 outbreak, to help clinical trials sponsors in adjusting their management of trials and participants during the pandemic.
The guidance covers how to deal with, for example, the self-isolation or quarantine of trial participants, limited access to public places (including hospitals) due to the risk of spreading infections and reallocation of healthcare professionals. It also advises on how to communicate these changes to the national competent authorities.
It provides specific advice on clinical trials for COVID-19 treatments, including the need for large, multi-national trial protocols.
This in line with the CHMP’s call urging the EU research community to prioritise large randomised controlled clinical studies as these are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential COVID-19 treatments.
- Mar 26 Commission eyes MDR postponement by one year
The European Commission announced on 25/03/20 that it will work to propose to the postponement of the implementation date of the Medical Devices Regulation (2017/745 – MDR).
In light of the fight against COVID-19 and its numerous consequences on the healthcare systems and all actors, including industry, DG SANTE took the decision to put forward to the Parliament and the Council the proposal to postpone the MDR by one year.
EUCOPE welcomes the proposal as it will give time to small and medium companies to devote their efforts on the fight against #COVID19 and allow for a proper implementation in a year time.
For more information on our work on Medical Devices and In Vitro Diagnostics Devices, please contact Laurent Louette (email@example.com).
- Mar 19 COVID-19: Monitoring any Shortages or Distribution Problems
EUCOPE and its member companies are closely monitoring the COVID-19 situation and its potential impact on the manufacturing and distribution of medicinal products. EUCOPE is reporting any expected shortages or distribution problems due to the COVID-19 outbreak and/or current cross-border restrictions put in place by some EU Member States to the European Commission, the European Medicines Agency, and national competent authorities.
For further information, please contact Dr Oliver Sude or Laurent Louette at firstname.lastname@example.org