An advocate of collaboration : Flora Giorgio interview

Published on: Apr 4th, 2019

Eric Wery, Vice President Market Access at VCLS conducted an Interview with Flora Georgio, Head of Sector HTA European Commission where she discusses her role and outlines how she supports interactions with numerous stakeholders.

Q: Could you tell our readers a bit about your background, and something about your organisation?

The European Commission is the executive organ of the EU, which proposes new legislation and reinforces and monitors the implementation of the existing one. At DG SANTE, we deal with public health, medical products and innovation, as well as food, animal and plant health. To work effectively, we are divided into directorates, which are organised in different units responsible for specific topics/policy areas. Currently, I am the Team Leader of the Health Technology Assessment team (HTA), part of the unit specialising in health systems, medical products and innovation.

My experience at the European Commission stretches over more than ten years. Before joining DG SANTE, I was at DG CNECT, working in the area of eHealth. Even before joining the Commission, I wanted to work on the European level and joined the EU Pharmaceutical Group where I was Secretary General until 2006. Given my scientific background in health – I am a pharmacist – and am very passionate about the beneficial impact that cooperation on the EU level can have on the health of European citizens.

Q: What does your current role involve, and to whom are you accountable?

In my daily work as the Team Leader for Health Technology Assessment, my team has many tasks. Before we draft the HTA Proposal, we carried out an impact assessment process, which included several consultations and evidence gathering to demonstrate the benefit of EU cooperation and the rationale of
the proposal. This was in line with the Better Regulation Agenda which defines the process of EU law-making.

Today, with the proposal on the table, we are negotiating it with the co-legislator, the representatives of EU countries and with the European Parliament. This entails several meetings and regular interaction. In addition to meeting within the institutional framework, we also spend a lot of time discussing and presenting the proposal to stakeholders at conferences, such as the TOPRA Symposium and in bilateral meetings. We are also very involved in monitoring the activities of the Joint Action EUnetHTA, which is an EU co-funded project that already provides a framework of cooperation between HTA bodies. The European Commission defines these activities in its Annual Work and Management Plans, in agreement with other EU Institutions (eg., the Council representing member states and the European Parliament, elected by European citizens).

Q: What are considered to be the main strengths and weaknesses of the HTA system currently in place within Europe?

Currently, there are more than 80 different national authorities involved in HTAs in the EU. While in some countries HTAs are carried out in a timely and sophisticated manner, other countries do not have the capacity to carry out the assessments themselves. There have been regular international exchanges regarding aspects of what is now known as HTA since the 1990s. Over time, countries have made more concrete commitments to cooperation as can be seen from the longstanding EU-wide cooperation eff orts known as the EUnetHTA Joint Action, active for almost ten years in different formats.

More recently, a number of regional cooperation initiatives have also been developed. While aiming at joint pricing negotiation to improve access to technologies, La Valletta, Beneluxa, FINOSE, the Nordic Council and the Fair Pricing Initiative also anticipate some level of joint HTA, if not already available via EUnetHTA. These collaborative networks, as well as the several calls from the Council of Health Ministers and the European Parliament, show that there is a need for further collaboration. Although the current framework of cooperation has enabled HTA bodies to work together, share expertise and build know-how, it is still subject to important barriers and weaknesses. These include administrative and legal barriers to work together effectively, limited possibilities to use the output of joint work, including
joint clinical assessment reports; limited predictability of the system throughout and a lack of long-term sustainability. The European Commission has presented a legislative proposal for a cooperation framework on HTA to address these issues and to reap the full benefi ts that a structured, high quality and predictable EU cooperation framework for HTA can bring to all parties.

Q: How does your organisation plan to respond to the trend towards more complex, typically higher cost, medicines (eg, biologicals, advanced therapy medicinal products, personalised medicines) in the future?

The observation that medicines are becoming more and more advanced is an important one. The cooperation between the Commission and EU member states is vital to ensuring that everyone has access and can obtain the best available medicines. The current cooperation initiatives on HTA, as well as in other policy areas, have already shown the benefit to member states of pooling their expertise. Considering the ever more complex pipelines of products, not only in pharmaceuticals but also in the areas of devices, we believe that not even the large, well-established agencies will have the expertise and resources to assess them alone. This was the reasoning behind our proposal. Our objective is to bring the benefits of a high quality, transparent and structured HTA process to all member states and, ultimately,
to all patients in the EU.

It is, however, important to clarify that this proposal does not change the role and responsibilities of member states in deciding on their pricing and reimbursement policies. The EU cooperation framework would only provide the possibility that all HTA bodies could jointly assess the certainty and the validity of clinical evidence, which would then be used, with all the additional elements, in decision-making at a national level.

Q: Has the increased collaboration between HTA bodies and regulators in recent years been successful? Is there a need to strengthen the collaboration with other stakeholders, and if so, which ones? How do you think this might be achieved?

The EUnetHTA Joint Action has developed and implemented a set of joint work plans with the European Medicines Agency (EMA). Such cooperation has resulted in a number of concrete changes in practices. Some of these are more visible, for example changes in the structure of the EPAR [European public assessment report] were introduced to respond to the evidence needs of HTA bodies, others have resulted in joint procedures.

One example is parallel scientific advice, where the EMA and HTA bodies jointly meet technology developers to provide advice on the development plan of the technology. Others, resulting in regular exchanges of information, under strict confidentiality requirements, enable assessors responsible for performing a joint HTA under EUnetHTA to interact with the rapporteurs, who provided the regulatory opinion. Such interaction has helped both parties to better understand certain decisions and has helped in the assessments.

We consider the ongoing interaction a success for what it has achieved under the current framework. However, it also faces challenges in relation to the possibility of exchanging information. The Commission Legislative Proposal also aims to provide more legal certainty for such collaboration.

Q: As a market access expert, my perception is that the current model of drug development does not seem to be working well. What can the European Commission do to improve integration of academic, industry, patient and payer stakeholders and to incentivize risk-sharing?

Indeed, all member states face the common challenge of ensuring access to innovation while preserving the sustainability of healthcare systems. Access to technologies is a national competence and therefore the Commission can only contribute within its remit and responsibilities. Within this remit, we support
initiatives aimed at promoting cooperation, by helping member states who are willing to share information, expertise and know-how. We also provide tools for their decision-making, such as the
EURIPID database.

In the specific area of HTA, the EU proposal aims at doing just that. The proposal focuses on the cooperation between member states, but it also lays the groundwork for a stakeholder’s network associated with the framework, which would gather the key stakeholders. From our experience in other policy areas, as well as in the specific case of HTA, we feel that just bringing the key players together, sharing different perspectives and understanding different concerns can help us develop solutions to a common challenge. We do not have a solution for the model of drug developments, but cooperation brings new ideas, which are being tested and approved and can hopefully provide some solutions.

Q: And finally, on a more personal note, where do you see yourself in five years?

Over the years of dealing with HTA, I have developed a personal interest and commitment to this initiative. I believe that similar cooperation frameworks could bring important benefits to EU patients and the society as whole. I hope that in five years I will be discussing with national authorities the implementation of the HTA legislation and will contribute to setting up the cooperation framework.