The speed and relevance of assessing health products

5 Oct
Emmanuel Giménez

The European market of health products has been widely affected by the sudden emergence of a new legislative framework with the new regulations (2017/745 and 2017/746). The subtle difference between directive and regulation is paramount, they say, but we’ll leave that for another occasion. This new framework in the field of health products is characterised among other things by:

  1. A stricter control of high risk health products (for example, certain implantable products)
  2. The strengthening of rules of clinical evidence by including a coordinated procedure at a European level for the authorisation of multicentre clinical research.
  3. The reinforcement of requirements and the coordination between European countries regarding controls and after sales aspects.

In this context of important changes, the assessment community is also clearly active. Thus, on 19 June this year, there was a panel on health products at the international meeting of Health Technology Assessment HTAi, where a new and innovative Italian programme for health products was presented.

The programme, explaining the work carried out over several years in terms of definition and its pilot phase, includes three work packages: appraisal, methodology and monitoring. In another panel closely related to the previous one, in the field of methodology, the presentation of the categories to decide on what to invest in and what to disinvest win clearly stood out.

When talking about monitoring and collecting information, an example that stood out was the debate on the need for early assessments given that the life cycle of a health product tends to be short.

The significant increase in new products available and all the work objects previously mentioned are some of the things that position the importance of specific assessment in health products.

The importance of the assessment of health products is, therefore, undeniable. In the joint production work package of EUnetHTA JA3, in which AQuAS is participating, as many or more assessments of “other technologies” (health products, health interventions,…) have been planned as of the known assessments of drugs. In a sense, the numbers of one or other necessity are matched. The importance of the assessment of “other technologies” was in fact reflected in the HTAi annual meeting in a presentation by Wim Goettsch, director of EUnetHA.

The identification and prioritisation of products to be assessed (the Horizon Scanning system), as well as the balance between innovation and divestment, are also extensively discussed subjects and under continuous debate. Thus, in the REDETS network (in which the AQuAS is also actively participating) and with the leadership of Avalia-T, a public access tool was identified that helps in approaching this subject: the PriTec.

Assessment, therefore, can help directly in the use, management and sustainability of different health systems. In conclusion, new opportunities are provided for improving decision making in the area of health products and some of them will come through demonstrating efficiency by means of the adequate use and definition of health technology assessments (HTA).

Post written by Emmanuel Giménez.

In memory of professor Joan Rodés

12 Jan
Joan MV Pons
Joan MV Pons

With his passing away, Dr Joan Rodés (1938-2017) will be remembered by many people in person, and in many fields, for those who had the good fortune to know him as a doctor, researcher, manager and assessor (of politicians), as his was a life full to the brim. No matter which professional activity he took part in, and with the responsibilities he took on throughout his life, he left his mark and the accolades expressed these days are a clear demonstration of this.

To AQuAS (originally AATM), Joan Rodés has been an exceptional figure and I say this without any rhetoric whatsoever. When the Agency was created in 1994, he presided its scientific board of assessors and at the end of 1999, when the institution became known as Catalan Agency for Health Tecnology Assessment and Research (CAHTA), in Catalan Agència d’Avaluació de Tecnologia i Recerca Mèdiques (AATRM), he presided its Administrative Board, a position that he held till 2010. It was in that period (2000-2006) that, due to my responsabilities within the Agency as Managing Director, I was able to get to know this great personality more closely, very much a big strong fellow (in Catalan, a homenot) was Joan, as Josep Pla would say. At that time, we saw each other often, and I had frequent exchanges with him, aside from the more or less termly meetings of the Administrative Board. I did this in that minute office of the haematology services and later in that of the General Manager at the Hospital Clinic.

No matter what the position he occupied, he was always watchful -very much so- of events at the Agency, being a great facilitator of its duties. It was like this, without a doubt, because with Joan Rodés there was no need to convince him of the importance of informing well about decisions taken in the health services, using the most updated and precise knowledge that was available, not only that regarding the benefits and risks to health of medical interventions, but also in terms of its economic, ethical and social impact. For him and I quote his words literally from the AATRM Newsletter, 10 years of the Agency, of November 2004:

“critical assessment and continued learning are basic tools that need to be maintained and improved, not only by the Agency, in its everyday activity, but also by all the multiple actors and stakeholders in the health system (professionals, managers, politicians and citizens) that wish to continue sustaining this element of such importance for our social well-being”

I said this because of his role of facilitator as highest representative of the Agency giving constant support to the activities it carried out, but also because of his extensive experience and network of relationships that contributed to giving strength to many initiatives that were then being undertaken, especially in the field of research and its assessment. I was able to discuss this with him on many occasions at a later date, and I never once perceived an interventionist or managerial attitude; quite the opposite, always with a laissez-faire approach where each one had to do their assigned task (the technicians and managing director of the Agency, the scientific board and the administrative board) while facilitating that of others.

It has always been a great pleasure for me -a privilege better said- to have maintained contact at dinners and get-togethers, even during the last period in which his respiratory illness worsened, but he would still go to IDIBAPS from time to time despite this. I cannot end without saying that during those times when we would talk about any and everything (medicine, science, politics, society, the past, present and future) we had a really good laugh. Then as now that you have left us, you are and will very much be in my thoughts.

Post written by Joan MV Pons

agencia-2004-ca
Joan Rodés presiding an Administrative Board of AATRM in 2004

Is it possible to combine active and healthy ageing with innovation?

22 Dec
toni-dedeu
Toni Dedéu

The European Innovation Partnership on Active & Healthy Ageing (EIPonAHA) is an initiative of the European Commission to deal strategically with the social challenges associated to active and healthy ageing, to make good practices in innovation more visible and to facilitate exchanges between regions, all of which promote interregional cooperation and the value of excellence.

What is its aim? To improve the health and quality of life of Europeans, especially of people older than 65, and to give support to the sustainability and efficiency of health and social care systems in the long term as well as to enhance the competitiveness of EU industry through expansion in new markets.

The reflection on how health systems interact with an ageing population and care in chronicity has been been one of the main lines followed in the AQuAS blog during 2016; they are subjects that affect our society and, precisely because of this, are part of the Health agenda.

In this context, having links to European projects is fundamental, where networking, collaborative projects and assessment are absolutely essential.

eiponaha

This is the underlying idea of the Reference Sites awards which assess regional European health ecosystems based on four axes:

  1. Political, organisational, technological and financial willingness for an innovative approach to active and healthy ageing
  2. The capacity to share knowledge and resources for innovation
  3. Contributiing to European cooperation and transferability of own practices
  4. Providing evidence of positive impact

The status of “Reference Site” is awarded to systems, alliances and ecosystems in health which comprise different players at a regional European level (government authorities, hospitals and care organisations, the health industry, SMEs and start-ups, research and innovation organisations and civil society) which have invested in developing and implementing innovative-based approaches to active and healthy ageing. These practices must be carried out with a comprehensive approach and vision and proof of the impact of their results must be provided.

Four stars is the highest distinction awarded by EIP on AHA and this is the score obtained by Catalonia as a leading health ecosystem and a reference for institutions and European organisations in the area of innovation in active and healthy ageing. These factors encourage the internationalisation and visibility of the Catalan health system and at the same time increase the possibilities for creating initiatives and forming consortiums for collaborative work with other European regions.

Being self-critical of the  different health systems is as important as the knowledge and recognition of one’s own strengths and values. Sharing this is a way of acknowledging the involvement and work done by many professionals. We do not work in isolation; as a whole, this work has involved and involves AQuAS, the Fundació TicSalut, the HUBc (Health University of the Barcelona Campus), the ICS  (Catalan Health Institut),  the IDIAP Jordi Gol (Institute for Research in Primary Care), the Pere Mata Institute, the IRB Lleida (Biomedical Research Institution of Lleida), the VHIR (Vall d’Hebron Institut de Recerca), the Consorci Sanitari del Garraf  and the Institut Guttmann.

Last 7 December in Brussels, on behalf of the Department of Health, I received the award for the Catalonia Reference Site group given by the European Commission. It is relevant because this fact defines Catalonia as one of the most dynamic and leading European regions in number and quality of initiatives, investment and results in generating and implementing innovative solutions to resolving problems in care and health to elderly people, chronic patients and other groups of risk patients.

The fact that Catalonia has obtained this distinction from the European Commission has a very clear meaning: Catalonia is recognised as one of the leading European regions regarding active and healthy ageing and innovation.

On we go.

Post written by Toni Dedéu (@Toni_Dedeu), Managing Director of AQuAS.