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This Newsletter aims to provide information regarding the latest successes, opportunities and changes in UAEM, as well as the most important news from the intersection of intellectual property and global health.
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Dear UAEMers all over Europe!
We are pleased to share with you our latest issue. Feel free to send us some content for the next edition
 (uaem-europe-newsletter@googlegroups.com): about your chapter, global health issues, a specific project or idea ... It will be very much appreciated! We would like to hear what you think about this month's edition, too.
Also, our dear member Josefine is leaving our team and will be backpacking in Asia for a year. We thank her for her great work and wish her all the best!
Enjoy reading and have a great summer!
The Newsletter team -- Andia, Chris, Irene, Yuri and Josefine
Table of contents

Upcoming events

Would you like to participate as a UAEM representative and host a workshop at the following conferences? This is a quick reminder from the Empowerment WG to invite you to apply! Spread UAEM's word everywhere in Europe! Please send them an email ASAP! Note: From now on, these conference calls will be published directly in the newsletter, so keep yourself posted about these special opportunities! You can join the Empowerment Working Group if you wish to participate more actively in these activities.
Board

Dear UAEMers,

 

This summer the board evolved and grew to eight members including four newbies, Alan & Kush from the UK, Tommi from Austria and Max from Germany. We had our first physical meeting in Berlin at the UAEM office on the 19th-20th July where we were fortunate to have Lukas before he went for his summer break. We began with a handover to explain the role of the board and procedural issues for the new members and then we assigned roles for the year to come, with a key person identified for each area of legal/fundraising/HR etc in order to improve accountability.

 

We spent much of the weekend reviewing how we’d done in the previous year, and highlighting areas for improvement, and we hope the new role of campus organiser as well as two new interns will help with these issues. The board then put together an agenda for the upcoming European Leadership meeting which will see the board, ECC and ED come together in November in Berlin.

 

The board then briefly discussed the next Annual European Conference which is to be held in the UK and our input into the SSWG which has just begun brainstorming ideas for a more sustainable future structure for UAEM Europe.

 

We look forward to hearing about UAEM continue to grow, just as it has within the board. As ever, if you have any questions about our work, you are welcome to email us.

 

Sincerely,

UAEM European Board

Tommi, Alan, Kush, Chris, Clara, Johannes, Max & Caroline

 
SSWG
SSWG – this is the latest of the so many, many acronyms UAEM invents and uses on a daily basis. The Sustainable Structure Working Group (SSWG) is a small group consisting of a board member, a European coordinator and four other UAEM members.
 
As UAEM Europe is growing rapidly, there are also coming problems with it. The more people we are, the more difficult it will be to keep an overview of all activities, and the need for standardised processes arises. At the last General Assembly in Basel in April 2014, the European board proposed the creation of the Sustainable Structure Working Group - which was approved. Now, the SSWG has the task of evaluating our current UAEM structure and will work on a proposal with the consultation of all UAEM members.
 
We had our first Skype call in July and started brainstorming immediately. At the moment, we are preparing a questionnaire for all UAEM members. We are in close contact with the European board and the European Coordinating Commitee and also got in touch with the pilot Global Governance Council. We are trying to include as many opinions as possible before we finalise our task and write up a proposal for the upcoming GA in London!
 
Everyone is free to contribute and send us their ideas and suggestions!
 
Kind Regards,
The SSWG
European Working groups

Update from the A2M Week 

Hey UAEMers, here an update from A2M week. We're currently looking for a petition to launch during the A2M week and have been collecting ideas. The petition should run Europe-wide and will hopefully have a huge impact.  
 
Currently there are three ideas on the table:
  • TIPP
  • Hep C
  • De-linkage
We're currently specifying the petition ideas and will vote on one to persue soon. 
Interested? Which one do you think suits best for our A2M week? Or have any extra input or ideas? Get in touch with us via a2m-uaem@googlegroups.com
Andrea Mauracher & Friha Aftab 

The Access & Innovation Breakfasts/Soirées Project starts next fall ... at your university!

The Access and Innovation Breakfasts/Soirées project aims to introduce in academia new values in the R&D system, which is currently market-driven, following Big Pharma’s interests and profit. University is the place to set these new ideas. But how well are researchers and academics in general aware of this problem and of this potential solution? We can use the strength of our UAEM network to involve our academics and build up a broad de-linkage movement within our universities.

Luckily, there is a way to create a more health driven system: de-linkage (see this short explanation of de-linkage). This means de-linking the costs from R&D from the production costs.

We are witnessing the rise of a broad public movement to promote this “de-linkage paradigm” and transformative models of innovation to establish a more equitable, affordable and needs-driven R&D system. We think that students can introduce these innovative ideas in our universities, which are the perfect place to set up a radical change in R&D models. 

There are already flourishing experiences (such as the implementation of SRL policies thanks to UAEM-driven activities in some universities) and we think we can make this global, on a European scale. It will be UAEM’s task to leverage academia’s voice in favour of a more equitable and affordable R&D system. Every interested chapter will be provided with material/support/trainings to hold regular meetings with interested researchers at their Universities, to convince them to enter a broader Access & Innovation movement.

We are currently looking for UAEMers who would be interested in participating in this project. We will have a Skype call to set up the bases and our goals at the end of August. Please join us by adding your name to the doodle poll. If you have any questions or you want to participate in the project please send an email to merel.c.philippart@gmail.

 
News from our chapters

A surprise from UAEM Austria 

Recruitment tip: the perfect cake recipe 

 
On the 29th July the members of UAEM Vienna came together to hold a large internal workshop focusing on the A2M-week. Above all, of course, there was one question that needed to be answered: “How do we make the A2M week the most amazing event of the year?” 
The brainstorming just went on and on. Luckily there was enough food to stay energized till the end, and most importantly: the cake. In the evening we had many good ideas, like flash mobs, presentations, movie screenings, panel discussions, parties, workshops,etc.
We want to share this energy with you and send you one of our favourite and secret recipes! Enjoy baking and stay tuned!  
Ojundar Batnasan, Coordinator of the A2M week Austria.

Ingredients:
125 gram flour
180 gram sugar
120 gram butter
100 gram dark chocolate
125 milliliter water
10 gram cocoa powder
1 egg
1 teaspoon baking powder
1 package (13 gramm) vanilla flavoured sugar
1 tablespoon crème fraîche or sour creme
for decoration: icing sugar

Preparation:
1. Take a round baking pan with a diameter of 20 cm and line the ground with baking paper. (If you don't have a baking pan of 20 cm but one with 26 cm, just take twice of the ingredients. The cake will be a little bit higher.)
2. Preheat the oven to 170 degree.
3. Put water, crème fraîche, butter, sugar, vanilla sugar, cocoa powder and the dark chocolate in pieces into a cooking pan and heat up everything on low degree. At times stir the mixture until butter and chocolate are restless melted.
4. Fill the mixture into a mixing bowl and let it cool down for about 15 minutes.
5. After 15 minutes mix in the egg as fast as can be. Stir flour and baking powder together and add one tablespoon of it after another to the chocolate-sugar-mixture while you mix everything.
6. Fill the result into the baking pan (caution, it's very liquid!) and bake it for about 40 minutes. If you like the cake a little bit like a devil mud pie, just bake it for about 30 minutes. That's my favourite consistence!
7. After 40 (or 30) minutes, take the cake out of the oven and let it cool. After you remove the baking pan, you can decorate the cake with icing sugar, frosting and anything else you like!
8. Guten Appetit!

All around the globe...

are UAEMers actively promoting access to medicines.

Basel Workshop Report #1
When collecting the reports on the workshops held at the UAEM Europe Conference 2014 in Basel, it came into our mind that it would be great to release them one by one on our newsletter. We’re aiming to present the reports in possibly palatable form, piece by piece, one workshop a time, to render the whole thing more digestible and the take home messages longer-lasting.
For those of you who attended the conference, this will refresh your memory of the things you’ve heard there – for those of you who haven’t, this will serve as a good source to learn more about the issues UAEM is concerned with!
Let’s start off with the workshop by Patrick Durisch and Eva Ombaka, on the ‘Consequences of Profit-driven Drug Research’.
Both speakers hold a Master of Public Health and are particularly interested in access to and promotion of rational use of medicines – so they know the issues they’re addressing. The veterinary doctor Patrick Durisch has 20 years of working experience with NGOs world-wide and serves as Health Programme Coordinator for the Swiss advocacy NGO Berne Declaration. Durisch discusses a few myths in access and innovation debates. Does increasing IP go hand in hand with increasing innovation? Are clinical trials conducted to the same ethical standards everywhere? And are these trials private goods?
Subsequently Eva Ombaka, who is trained as a pharmacist and has participated in prominent committees such as that of the WHO, takes the word and ventilates the questions of price and promotion. Take a look at the report, nicely written up by Chris Redd, yourself! 


The first part of this workshop focussed on dispelling some of the more prevalent myths in access and innovation debates.
 
Myth 1: Increasing patents = increasing innovation.
 
First up was the suggestion that increasing patents increases innovation. Take a look at the image below:
 
 
 
Although this picture suggests that innovation will not occur without protection, which is a point I dispute, the nonlinear relationship is key to grasp. Once we have established that you can have too much IP, we must question the utility of current standards. Again, Patrick turned to a compelling image:

 

Combined FDA-approved NMEs versus R&D spending for nine large pharmaceutical companies (AstraZeneca, BristolMyers Squibb, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Pfizer, Roche and SanofiAventis). Figures shown are in millions of US$ (from Nature Chemical Biology, June 2011)
 
Despite increasing IP protection, less and less molecules are being developed. There is an innovation crisis, bringing about a vicious circle. Dwindling pipelines and supposedly high costs of R&D are used to justify strengthening IP. And new drugs, when they are developed, are often
pretty low on the innovation scale.
On top of this, the current patent-driven innovation system revolves and profits instead of the needs of populations. Patents themselves provide a regulatory and legal burden to companies and governments alike, a point that UAEMers do not often mention. Lots of resources are invested in patent litigations and anticompetitive practices to delay entry of generics into the market.
 
Myth 2: Clinical Trials are conducted to the same ethical standards worldwide.
 
Increasingly, MNCs are offshoring clinical trials of their medicines to developing or emerging countries. Often these are in weak regulatory environments, where people are more willing to participate because it represents access to treatments they will not otherwise get. Despite the increased risk of ethical violations, EU regulatory providers exert no control over whether offshore trials submitted in marketing authorisation processes are compliant with international ethical standards. Why? Follow the money.



Drug companies make most of their money when a drug is on patent. You can see, from the picture above, that a patent runs for twenty years. Because a molecule is patented before it is trialled, pharmaceutical companies want to reduce the trial period as much as possible to get a market monopoly for as long as they can. So, if a pharmaceutical company can get things done quicker, and with less ‘hassle’, they will. And they do. The picture below shows the number of clinical trials by country in 2010.
 


From the map it is clear that, in general, by far the most studies are conducted in the USA and Europe. So why all the fuss?


 
The map picture doesn’t tell the whole story; it is static. The figure above shows the percentage of change in the geographical distribution of clinical trials between 2006 and 2010. As the title of the reference says ‘trials are moving out’.
The Berne Declaration commissioned five investigations between 2012 and 2013 regarding offshored clinical trials that were used as evidence for marketing approval at the Swiss medicines agency. These investigations were hoping to establish the quality of trials used for marketing approval purposes in Switzerland, and to evaluate how Swissmedic (the Swiss medicines agency) monitored these trials.
In destination countries there were failures of informed consent, abusive use of placebo, lack of compensation after iatrogenic adverse events, no continuation of treatment after the trial, use of substandard treatments as controls, and numerous regulatory and supervisory problems.
In Switzerland the ethical control of offshored clinical trials used in marketing authorisations was almost nonexistent. There was no contact between Swissmedic and the drug regulatory authorities in the countries where the trials were conducted. Even establishing which clinical trials were used was difficult, because the Clinical Study Reports were never made public. And, of course, the revolving door between industry and Swissmedic provided numerous conflicts of interest. In light of these findings, the Berne Declaration have launched their own campaign.
 
Myth 3: Clinical trial data are private goods.
 
The final myth was the notion that clinical trial data are private goods. Participants in clinical trials are involved for the progress of science, and contribute their bodies to further human progress. The information derived from experiments on these participations should thus be considered a public good.
Currently, clinical trial data is kept from the public domain by pharmaceutical companies. Secrecy is counter to the wishes of participants in two ways: (1) it prevents science from happening, and (2) it makes bad science more likely (e.g.Tamiflu, Vioxx, Avandia). While these issues are relatively uncontroversial, confidentiality is a common sticking point. Although Pharma may plead for ‘commercial confidentiality’, this is considered a non-issue in light of the new EU regulation. Patient confidentiality can, and should, be protected by codifying and anonymising data; this is fully compatible with making clinical study reports public.
All clinical study reports (CSR) should be made entirely public to allow independent scrutiny (systematic reviews). To find out more, go to alltrials.net, or read Bad Pharma by Ben Goldacre.
 
Dr Eva Ombaka then took our workshop further into the impacts of profit-driven health care infrastructure, focussing on two aspects in particular: promotion and price. Beginning with this
wonderful quote:
 
“Marketstyle reforms result in health care systems that are more unequal, more costly, more fragmented and less accountable – but which offer more profits to the private sector. That’s why
the question really is whether we want to see global health – or private profit.” John Lister
 
First of all, she focussed on the prices of drugs, and the difference between generics and brand name medicines, a problem that should be well known to all UAEMers. What UAEMers may be less familiar with is the fact that even after a drug comes offpatent, the branded version is still many times more expensive than the generic.
 
This price difference helps explain Dr Ombaka’s second topic: pharmaceutical promotion. By persuading doctors to purchase their drugs, companies can make more money. Drug companies spend vast amounts of money on these endeavours (more than research) which leads to prescribing practices more on publicity than scientific evidence. Promotion takes many forms, including, but not limited, to: adverts, sales reps, free samples, key opinion leaders  promotional ‘research’, gifts, websites, and industry-funded journals and articles.
Perversely, governments and authorities in the West have responded and clamped down on misinformation, drug companies have shifted their practices to developing countries.
 
What can you do about promotion? First of all, recognise that it affects you too:

 
 
One of the great successes of drug promotion is to convince individual physicians that it does not affect their decision making. While most doctors have enough common sense to identify the influence in our colleagues, how many of us are capable of admitting it in ourselves?
 
However, once we have come to terms with our fallibility, it is time to act. Dr Ombaka encouraged all participants to make these demands:
  • To demand transparency in the pricing of new drugs.
  • To advocate for delinkage of rewards of drug development to sales so that every patient who can benefit from a new drug has a chance to access it.
  • To support national medicines policies that focus on access for all, rural and urban, rich or poor!
  • To support strategies that promote generic uptake, such as generic substitution by pharmacists; and increasing confidence in generics by professionals and the public.
  • To work on mechanisms that empower communities to hold all stakeholders from industry to health authorities accountable!
 
Further resources on promotion and rational use:
Health Action International Drug Promotion Manual
Health Action International Online Encyclopedia of Pharmaceutical Issues
 
Discussions
 
What else could motivate pharma to develop drugs?
How do you assimilate A2M with metoo innovation?
Doesn’t rising standards for R&D only discourage investment?
Why should the industry fund its own clinical trials?
Why don’t countries such as Tanzania abolish TRIPs and develop their own generics industry?

 

Ebola from a UAEM perspective

There has been a lot of talk going on during the past weeks about what is happening in West Africa right now. The WHO declared the Ebola outbreak to be an international public health emergency. The deadly viral disease, endemic in African countries, spreads further on - at the time of writing, 1975 have been infected and 1069 have succumbed to the disease during the outbreak since spring 2014 (WHO, 14 August 2014). News on this dreaded disease is flooding the media world-wide. The fatality rate can be up to 90%, and there are no licensed treatments or drugs, but novel ones are being evaluated. To learn more about Ebola, read the WHO fact sheet.

During all this, UAEM Denmark had the chance to participate, represented by Ben Ebeling, in a debate on national TV. Don't miss the English/Danish show! We'd also like to