Tag Archives: regulation

Building gender equality

8 Mar
Iria Caamiña

The media systematically show us examples of the persistence of discriminatory situations for women such as the gender wage gap, the lack of women in managerial positions and the violence towards women, among other things.

These situations are a result of our social construct which is still based on an androcentric model where man is placed at the centre, as a reference of values and of the view of the world while at the same time subordinating women and rendering them  invisible.

Taking advantage of the fact that today is March 8, International Women’s Day, we would like to review and reflect on how we are tackling this reality with the Government of Catalonia’s public policies.

The history of gender policies of the Catalan Government Administration goes back a long way. The Catalan Women’s Institute was created almost 30 years ago and it was this institution which began to formulate programmes for equality with the aim of guaranteeing real equality between men and women. In this context, the concept of equality has been reinterpreted and broadened and is now multidimensional:

  • Formal equality: the affirmation of the equality of rights in legislation
  • Equality of treatment: the absence of direct or indirect discrimination for reasons of sex
  • Equal opportunity: the compensation of existing inequalities in the conditions and positions of women and men
  • Gender equality: the assessment and consideration of the diversity and differences between women and men

The evolution of the concept of equality has run parallel to the evolution of strategies for intervention by public administrations. The first programmes of policies for women were centred on guaranteeing equal rights and on the absence of discrimination between men and women. Later, once the shortcomings of this concept had been verified, new measures for positive action were introduced to guarantee equal opportunities. More recently, gender mainstreaming has been introduced and prioritised.

Gender mainstreaming is a concept that arose in Sweden in the early nineties of last century to promote policies for women and was incorporated in the international agenda within the framework of the 1995 Fourth World Conference on Women held in Beijing. The inclusion of this strategy to develop policies for women was a turning point.

Gender mainstreaming in the area of the Catalan Government requires the incorporation of the gender perspective in all policies and the promotion of specific actions in favour of women from the different areas of Government Administration. This is the framework within which work is being done at present by the Government of Catalonia. The Department of Health has taken part in the six programmes led by the Catalan Women’s Institute and also in elaborating the four reports on gender mainstreaming.

On the other hand, the drive and implementation of measures and actions linked to gender policies in the Department of Health takes place within the framework of the Work Group for gender mainstreaming. This group is made up of people of reference from all the units and entities of the department, including the Agency for Health Quality and Assessment of Catalonia (AQuAS), and it is coordinated by the Technical Cabinet of the General Secretary.

Aside from the achievements made based on measures taken and actions carried out, some of the most significant advances have been those made via regulation. Particularly noteworthy are:

Among the most noteworthy aspects of the Law of Equality (2015) is the regulation of interdepartmental bodies for coordination, in charge of applying gender mainstreaming both consultative and advisory in nature, and also of implementing mechanisms of collaboration, cooperation, control and sanction. Via this Law, the creation of the Observatory for Gender Equality was foreseen, a body which began functioning last June and of which the AQuAS forms a part of.

Despite the progress made, a lot of work remains to be done which we need to do together, not only as a legal obligation but also as a commitment to building a fairer society. No policy is neutral, and it affects men and women in different ways and this is why it is essential for us to put on our “gender glasses” during our daily tasks to identify possible differences so as to deal with them.

As you all know, dealing with gender is one of the editorial lines of the blog AQuAS (with posts written by Mercè Piqueras, Esther Vizcaino and Dolores Ruiz Muñoz) and we will be delving deeper into this subject shortly within the framework of the activity done at the AQuAS.

Post written by Iria Caamiña.

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.

Scientific evidence and clinical practice: the case of hip prostheses in Catalonia

9 Mar
Daniel Chaverri, Miquel Pons, Luis Lobo

A total hip replacement is one of the surgical procedures which provide greatest satisfaction among patients due to the significant improvement in the quality of life they experience.

So much so, that it has been defined by some authors as the surgery of the 20th Century. It is a procedure which consists in substituting the hip joint with an artificial joint or prosthesis.

The most common reason for surgical intervention is arthrosis, a disease caused by the wear-and-tear of the cartilage which leads to a malfunction of the joint. It is especially common in older people, older than 65, who live with pain and which can limit their day-to-day activities considerably.

In today’s context of continuous technological innovations and advances and facing the enormous pressure from manufacturers, the range of prosthesis available to orthopaedic surgeons is wider than ever. This situation demands that the prostheses used have supporting scientific evidence based on clinical studies or on data from arthroplasty registries.

The legislation which regulates the commercialisation of medical devices, such as prostheses, is more lax than that which regulates drugs which means that not the same type of studies are required for their approval and in consequence, neither is the scientific evidence. In fact, this precise legislation is undergoing a review at present and a new one on this matter will soon be made available.

Several years ago, the prestigious journal BMJ (British Medical Journal) published an article in which it was highlighted that in the UK, 24% of hip prostheses used had no scientific evidence to demonstrate their clinical effectiveness.

As a consequence of that publication and applying the same methodology, at the Hospital Sant Rafael and in collaboration with the Catalan Arthroplasty Registry (RACat) of the Agency for Health Quality and Assessment of Catalonia (AQuAS), we embarked on the task of analysing what the scientific evidence was on hip prostheses used in public hospitals in Catalonia which had sent their data in to the RACat during the period 2005-2013.

We did this via a search on different platforms putting the spotlight on Orthopaedic Data Evaluation Panel (ODEP), as well as Tripdatabase, PubMed and Google acadèmic.

Following the analysis of the 18,816 acetabular or hip cups and 19,546 femoral stems (the main components of the hip prosthesis) collected in the registry, our first surprise was to observe that 123 different models of cups had been used and 138 different models of stems. In the group of participating hospitals in the RACat during the period of the study, it was seen that with many of these models less than 10 units in number of each had been used.

As these models only represent 1% of implants used, they were excluded from the study and in the end 74 models of hip cups and 75 models of femoral stems were studied.

Artroplàsties PTM

The results of the analysis, either recently published or not yet published, now at a pre-publication stage, show that less than 50% of components used had the highest level of scientific evidence in accordance with the ODEP. This top level is achieved when there are studies having 10 years at least of monitoring with a number of prostheses evaluated exceeding 500 units.

What also caught our attention was not finding any evidence for 18 hip cups or 16 femoral stems which represented, respectively, 13.56% and 9.53% of all implants carried out during this period.

Artroplàsties -taula

All scientific studies show limitations and it is not always possible to offer exhaustive results. Aware of this, and of the fact that the data in our study are the results of a research project which might not be able to reflect what the reality of public hospitals in Catalonia is in absolute terms.

We do want to stress that the task of the orthopaedic surgeon needs to be more and more regulated by evidence based medicine and this is, precisely, one of main purposes of arthroplasty registers: to carry out studies like the one we have been able to do at Hospital Sant Rafael with the aim of improving the health care of people.

Post written by Miquel Pons, Danieol Chaverri and Luis Lobo, Hospital Sant Rafael, Barcelona.