Debate: EU Health Emergency Preparedness and Response Authority: ensuring a coordinated EU approach for future health crises and the role of the European Parliament in this
Date: TUESDAY, 5 OCTOBER 2021
Speaker: Stella Kyriakides
Language: EN

Several of you raised the point of exclusion of the European Parliament. I have said it before and I will say it again: in order for the European Health Emergency Preparedness and Response Authority (HERA) to deliver on its mission in case of a new pandemic or a new health crisis, we needed to ensure that it had both the powers and the financial means to do so, and the only way we could do this was under Article 122 of the Treaty. Article 122 is the only legal base which allows the Union’s assistance to be granted to Member States when a Member State is in difficulty because of exceptional circumstances beyond its control, and this necessitates a proposal for a Council regulation in order to enable HERA to take a series of actions, including financial support triggered in a time of crisis. In the preparedness phase, HERA will rely on normal budgetary procedures and the European Parliament will of course be deciding on HERA’s budget but furthermore – and I have already said this – the European Parliament will have a seat on the Board of HERA. There will be an open, frank and systematic dialogue on all of HERA’s operations. I also wanted to tell you today that I have already written to the Chair of the Committee on the Environment, Public Health and Food Safety (ENVI) inviting the nomination of the board member.  Why did we set up a Commission service and not an agency? Three reasons. Speed. Establishing of an agency would have taken too much time. It would have taken a minimum of two to three years of interinstitutional negotiations. Money. The multiannual financial framework negotiations have just been concluded and there is no specific budget line for a new agency, and by establishing HERA as an internal Commission service we were able to make use of existing budget lines such as EU4Health, and you had such a crucial part to play in this and enabled us to have this budget – Horizon Europe and the Union Civil Protection Mechanism. Thirdly, agility. Because the existing models of European agencies do not allow agile decision- making by virtue of their legal character.  I also wanted to tell you here that the Commission can easily redeploy staff and mobilise funds in case of urgency and this is why, I think it was MEPs Zacharopoulou and Rivasi who raised this point. MEPs Fritzon, Guteland and others raised the point of what we wanted to achieve with HERA, whether it is falling short and more. HERA builds, I believe, and institutionalises our successful approach. It is all part of the vaccine strategy. We are proposing a complete end-to-end solution, from a very early identification of a threat to ensuring that the appropriate medical countermeasures are available for our citizens. And let’s not forget that HERA will be looking at all medical countermeasures, including therapeutics and diagnostics and even personal protective equipment. Vaccines are just one of them. HERA will finally be able to better coordinate and ensure coordination between the EU and the national initiatives on crisis preparedness and response. This is something totally new and an area in which HERA can make a real difference.  There was a question, I think from MEP Sofo, on the relationship between HERA and industry. I wanted to tell you this, and I think it is very important, HERA will be improving the Union’s development and manufacturing procurement of key medical countermeasures but to do this, HERA will need to have the preparedness mode functions as well as the capacity to take part in emergency measures so it is going to be working across all sectors – research, academia, NGOs, governments, and, of course, also with industry, because industry is a key sector in terms of medical countermeasures which are needed for health preparedness and health response.  Is it going to be a prolonged arm of the pharmaceutical industry? We will be working very closely with industry, including the pharmaceutical companies. This is inevitable. I think all of you that have worked from the very first day of this crisis know this. However, the role of HERA will be to guide industry and pharmaceutical companies into the directions that are needed to safeguard public health and HERA will ultimately, fundamentally ensure that public funds have public returns that serve to improve the health security of citizens. So, with HERA we are engaging in a new type of public-private relationships that will benefit EU citizens and the European Parliament, Member States and all the EU agencies will be very, very closely involved throughout the process.  Several MEPs raised the issue of the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA): why do we need a new agency, would we not be stealing staff? No, we will not be stealing staff. We will be recruiting new staff and we will be working with Member States’ experts and a Memorandum of Understanding in terms of how to govern the cooperation/collaboration between EMA, ECDC and HERA will be signed but I wanted just again to say that HERA will be supplementing with added value to the work already conducted by ECDC and EMA, both in preparedness and in crisis times without overlaps and in full respect of the mandates of both agencies but compared to ECDC and EMA, HERA will have a stronger anticipatory and forward-looking and responsive-focused dimension in terms of threat assessments and foresight, and will be able to scan the horizon for medical countermeasures. ECDC will remain the key actor in terms of risk assessments for infectious diseases, which is at the heart of its mandate, and EMA on the scientific advice on the safety and effectiveness of high-quality medicinal products, but EMA cannot engage with the private sector on the procurement or development or medical countermeasures, so there will be a very close cooperation, but there will not be an overlap.  MEPs Trillet-Lenoir and Auken spoke about transparency, and I believe this is a word that often comes up. All meetings will be subject to the applicable EU rules on transparency, of course, and public procurement and reporting. It goes without saying that HERA’s budget and expenditure will be subject to the discharge procedure in the European Parliament, which will remain the budgetary authority. HERA will not be able to spend money without your approval, and we will maintain a privileged dialogue with the European Parliament, which has a permanent seat on both the HERA Board and the crisis board.  I apologise for taking up more time, but I want to go through as many questions as I can. How do we have a proposal for which the European Parliament has no envisaged role? First of all, I want to thank you for the support you had given at the beginning for the European Health Union proposals, for the support you had given to this project that has become HERA. But let me be clear: the HERA proposals do have a role for the European Parliament and we look forward to working very closely with you. We could not have done this without you, and the Commission will invite Parliament to propose and set up a review process to ensure that you are closely integrated in the process and agree on its outcome.  It is, though, a different structure, like I said it at the beginning, MEPs Weiss and Guteland raised it, and I want to say this: because of the need to ensure a coordinated approach at EU level, both for preparedness and response, we decided to create a special board to steer the work of HERA and monitor its implementation. This is something which is highly unusual. It is not something we normally do. We faced a number of legal constraints. Member States are responsible for their own actions. We do not intend the HERA proposal to challenge the Treaty provisions. We cannot weaken the institutional prerogatives of the Commission, nor for the implementation of the EU budget. We consider that the HERA Board should include representatives of the national administrations and a representative of the European Parliament. Parliament’s representative – your representative – will have the full capacity to contribute to all the discussions and to assure a direct link between your political and legislative work, and I believe that this is important for the success of HERA.  MEPs Weiss and Liese asked about the sunset clause and whether we could introduce it in the proposal. I have already said that a review of HERA is foreseen and the results of the assessment will be shared with Parliament and Council and if justified, a subsequent proposal for a different second generation of HERA could be elaborated, building on the experience we have already gained.  Last but not least, I want to come to the comment – I would say it was a question, but it was also a plea – from MEP Ştefănuță, on the situation in Romania. We stand by to support every single Member State in every single way we can. I cannot agree with you more that we are all in this together and we need to work together to increase the vaccination uptake. This is a challenge in many countries and we need to do this if we are going to be able to target the pandemic effectively. I will speak with the MEP again to see how we can further support to Romania and these efforts.  I want to thank you for the openness today. I listened to all your comments carefully. I hope that you were able to also hear our responses to them. I take on board and understand a little bit why we put forward the proposal of HERA the way we have. Our approach has also always stemmed from a very honest intention to respond immediately, considering the threats that surround us and the gaps that have been identified, and I can just say one thing, that we are open to change if necessary. We have a clear willingness to get this right, but we cannot afford to find ourselves at the start of the pandemic, never again, and personally I will stand in this plenary as many times as I need to, to build the level of trust and transparency that you rightfully demand and that we all believe in.