Shortage of essential decisions Shortage of essential medicines (L5)

Can patients expect short-term, effective actions to ensure availability of their medication? This was one of the last questions asked during the lunch session on shortage of essential medicines. I believe it actually was the most important question which remained largely unanswered.

In the last decade, delivery problems of medicine have increased. In Estonia and France, for example, medicine shortages for respectively 118 and 116 human medical products have been reported. During the session, all relevant stakeholders sat together in a panel to discuss this growing problem, from politicians regulators, practitioners to the industry. Euro Commissioner of Health and Food Safety, Vytenis Andriukaitis set the scene. It is important to distinguish unintentional from intentional reasons for medicine delivery shortages. Unintentional reasons relate to the global pharmaceutical supply chains. Disruptions at raw material manufacturers, quality problems or packaging issues may cause delayed delivery. Yet, it increasingly happens that pharmaceutical companies intentionally lower production of certain medicine brands because of too low profit margins or small market sizes.

Listening to the different panellists convinced me that the solutions are abundant. According EMA regulator Kristin Raudsepp, there needs to be a stronger network for governments and regulators to prevent and respond to potential medicine delivery issues. The pharmaceutical industry itself also has to do it’s homework according to Raudsepp: pharma needs to improve on manufacturing capacity planning, logistics, regional forecasting demand, multilingual packages, and importantly, transparency. Richard Bergström, having worked in the pharma sector, largely confirms this: the responsiveness and traceability within supply chains can improve a lot. Everybody from the panel and audience seemed to agree on the fact that much needs to be done and that this requires action from policy makers, the industry and above all collaboration between them.

Thinking back about the mentioned most important question, asked by a patient representative, I had an uncomfortable feeling after the session. Are all these problem analyses and solutions going to prevent patients from missing essential treatments? I am afraid not. During the Gastein Forum one issue has frequently been raised: the current way in which healthcare in general and pharma in particular is organized and financed is unsustainable. Can we expect from large pharmaceutical companies, owned by shareholders who seek a maximum short-term profit, that they will do everything to assure delivery of not so profitable medicine? Recent years seems to show the contrary as both production of old and development of new medicine is falling behind. Importantly, the regulators and practitioners are caught in the middle and are only able to manage quick fixes. Politicians on the other hand, do not have the vision or capabilities to drive real change, as expressed by soon-to retire Commissioner Andriukaitis.

Maybe after 1 November we will find out if quick fixes are enough, or that the Brexit leads to a healthcare crisis that calls for essential decisions.

This Blog was written by Young Gasteiner Bart Noort.

European alcohol policies: Rethinking and strengthening implementation (F10)

Did you know that one million deaths per year in the WHO European Region are due to harmful use of alcohol? – and that these figures vary within and between countries in the region and by social group? Evidence also shows a clear relationship between alcohol consumption and life expectancy; if you decrease the former you can increase the latter. So why aren’t countries doing more to prevent this?

Well there are a number of challenges and barriers to implementation of alcohol relate policies, such as cultural resistance, strong lobbying, lack of political commitment, to name a few. Also, don’t forget about the commercial determinants of health – which relate to marketing, global money flows, trade agreements etc.

The session started with a number of setting-the-scene presentations by several expert panellists; participants were then asked to break up into groups to discuss the following challenges and to try to come up with ideas on how to address them:

  • Challenge 1: How to overcome barriers for implementing WHO best buys – policies that have proven to be cost effective – reducing availably of alcohol, taxation, and marketing?
  • Challenge 2: How to create a fora that will not end up being a ‘talk shop’ and ‘white-washing’ that avoids conflict of interest?
  • Challenge 3: How do we mobilize public support and shift the social alcohol norms to create a transformative change for health and well-being?
  • Challenge 4: How should we enforce, monitor and evaluate process in the implementation of alcohol policies and actions?

What came out of the session was the need for better understanding of the root causes and social drivers around harmful alcohol uses – to assist to establish alternative, effective interventions. Alongside that should be the implementation other interventions such as product replacement, taxation, the promotion of healthy-lifestyles, restrictions of opening hours in pubs, alcohol bans in sports centres and events, and reducing the size of alcohol bottles etc. Also, a coalition rather than a fora could be established. But whatever is done, it needs to be packaged in a clear, strong and unified message, and supported by strong collective leadership.

Written by Young Gasteiner Lucinda Cash-Gibson

Lunch Session: Making real world data real – new methods for EU health technology assessments (L7)

Bullet points:

  1. We do not measure what matters most to patients
  2. There are economic disincentives for hospitals even if the drug is less invasive – this should not happen
  3. In the 21st century we are still trying to provide healthcare that is not working
  4. We need to think big and globally when it comes to health data to provide better care for all
  5. We need complete and robust data in order to work effectively
  6. We need large amounts of data to give us real insights, the patient is a single outcome, but the input has to be much larger

Title: Health data – a matter of safety, robustness and advancement

In healthcare we constantly need to make accurate decisions based on efficient and correct assessments of not just the short- but also long-term value and performance of new therapies and drugs for patients. We need robust and especially complete data from patients. This however poses challenges in terms of data protection, regulatory approvals to meet comparative effectiveness and value in terms of health outcomes. Experts and advocates discussed the above matters during the lunch session on Friday, 4th October 2019, titled: Making real world data real – new methods for EU health technology assessments.

Amongst the experts, Dr Anja Schiel (Senior Adviser & Statistician, Unit for HTA and Reimbursement, Norwegian Medicines Agency (NoMA)) addressed the uncertainties faced during the conduction of clinical trials often resulted from incomplete and flawed patient data. She encouraged the audience to always pose questions such as (i) what data do we need to generate in order to answer the posed questions (ii) what does the data we have exactly tell us and (iii) is the data we gathered robust and complete to draw conclusions or allow further research.

The ‘Health Technology Assessment’ was introduced to the audience as the systematic evaluation of the properties, effects and/ or impacts of health technology and a health economics model to predict future scenarios based on existing available data. Dr Schiel stressed the importance of contextualising data in order to be useful and applicable in different national health care and its finance systems. This implies that treatment and economic-based decisions are reliant on robust evidence. Dr Schiel also posed the question why what was good enough for approval is often not acceptable for reimbursement anymore.

Audience and experts also discussed the crucial aspect of patient data safety initiated by a comment from one of the participants outlining the need to especially protect data of vulnerable groups such as migrants. Participants agreed that there is the danger of data falling into hands of those using it to commercialise needs and this has to be prevented. Patients have the right to share their information with whomever they want and it is the system’s responsibility to keep the data safe.

The healthcare sector needs robust data to advance and optimise treatment for patients. This means that public health professionals and those using data for research purposes need to communicate why and how data is used to increase the willingness of sharing.

This Blog was written by the Young Gasteiner Anna Stielke

Obesity in Europe – time for a new approach? (F8)

We have all heard the words chronic diseases and non-communicable diseases before. But have we ever considered defining obesity as one? In this afternoon’s session, Jacqueline Bowman-Busato, the policy lead of the European Association for the Study of Obesity, asked a controversial question: What would happen if Europe approached obesity like other chronic disease epidemic and focused on addressing the biological causes in approaches to policy along the obesity continuum?  

We have all heard someone say “just eat less and exercise more and you will lose weight.” Is that the magic formula to solving the challenge of obesity? Clearly not. Despite a set WHO target to halt the rise in diabetes and obesity by 2025, prevalence is rising globally. Across Europe alone, almost all countries have an obesity prevalence above 15%. But the worse news is that it keeps increasing, meaning that whatever we have been doing to address the problem is failing. Why is that? As highlighted by Abd Tahrani, an NIHR clinician scientist, we are failing because we are not treating obesity as a chronic, relapsing disease, but as an individual choice and despite severe long-term health, social and financial repercussions, health care systems around the world are failing those living with obesity.

Yet, the complex foresight obesity map highlights the hundreds of inter-linkages surrounding and having a direct – or indirect – impact on individuals. For the scientists and biologists in the room, Abd Tahrani also stressed that obesity meets the American Medical Association criteria to be classified as a disease, namely:

  1. It leads to the impairment of normal function
  2. It has characteristic signs or symptoms
  3. It causes harm or morbidity

While this lesson in obesity 101 was enlightening and hopefully led many people around the room to have a “Eureka” moment, I still wonder if calling obesity, a disease really is the solution. How is that going to change the number of challenges that exist such the awareness, discrimination and stigma associated with those living with obesity, or address infrastructure, health system and data challenges?

Current treatment and prevention interventions focus on directly tackling obesity but fail to address any of the underlying causes. But what about the impact of our external environments? Supermarkets are filled with products high in fat, sugar and salt. We are bombarded with advertisements that shows the consumption of excessively sugary drinks as very appealing. Cities are built in ways that promote sedentary behaviours. Does an individual approach to the treatment and prevention of obesity take into account any of these environmental factors or the different stakeholders that play a role in sustaining – and even encouraging – these environments? People living with obesity are stigmatised and discriminated against. What if we shifted our angle of attack? It is time to change the narrative about obesity and adopt a systems approach and shift the blame away from those living with obesity and acknowledge that it is the result of the complex interactions of many factors that surround us on a daily basis.

Health systems around the world are failing people living with obesity. We need to stop pointing fingers at those suffering today and start an open, non-discriminating dialogue that includes all stakeholders. This approach needs to empower individuals to leverage the system. This is everyone’s responsibility and our work start today. So now I am asking you: is it time to adopt a new narrative to address obesity?

This Blog is written by the Young Gasteiner Margot Neveux

Facts. Figures! Fiction? Who will take the power to lead the conversation?(L1)

In the era of technology and the broad availability of information, health care professionals are facing the problem of finding the relevant and accurate information in the haystack.

The Lunch workshop 1 on ‘Facts. Figures! Fiction?’, chaired by Martin McKee (LSHTM) and Claudia Habl (Gesundheit Österreich GmbH) tackled the problem of ‘fake news’, data quality and the availability, interpretation and dissemination of information – and who influences each of these. He stresses that the term is often used without a clear understanding of what it means, and that we need to be able to distinguish between ‘misinformation’ (often involuntary), ‘disinformation’ (purposely deceiving people), and ‘fake news’ (a weaponised form of disinformation spread in a way often mimicking news media trustworthy content). However, in practice is often very difficult to make a difference between the categories. For example, anti-vaccine propaganda may be spread by those who have a genuine concern (however misguided about safety) or by those who are using the issue as a tool to undermine trust in particular governments.

Fake news is not contemporary and it is not new – it can be traced back hundreds of years when fake news was used to blackmail or extract money. What has changed is the technological landscape, that allows broadcasting them wider. Fake news has a broad definition that spans anything from satire to harmful lies used for political campaigns. In the media dementia can be beaten by following some simple rules: ’Chocolate can halt dementia’, ’Red wine pill stops dementia’, ’Lose weight to beat dementia’, ’Coffee fights Alzheimer’s’, ’Spicy diet can beat dementia’, ’Stay married beat dementia’ are only some of the examples. 

To test your knowledge, ask yourself true or false?:

  • Electronic cigarettes have been shown to be 95% safer than conventional ones
  • The increase in children obesity is because children spend all day on the iPods and watching television
  • People who are very ambitious highly driven are at great risk of having a heart attack

If you are not sure. Where will you look for answers? Who drove these collective insights? In the end, we all have to know that more data does not necessarily yield useful findings and it can lead to „data fishing“. No amount of data available can help overcome poor research methodologies. We need to remember: data, information and knowledge transfer do not stand for themselves – who has the power to lead the conversation?

This Blog was written by the Young Gasteiners Zeljka Stamenkovic and Mateusz Zatonski