Arkiv för ‘Sverige’ Category

Phase 2 of the MistraPharma project has been granted

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Good news for all of us who want to see more knowledge being developed and better understanding on relevant mitigation measures for any environmental impacts from pharmaceuticals:

MISTRA, the foundation for strategic environmental research, have granted a phase two of the MistraPharma program: 52 million SEK, over four years.

It is also interesting to see that on the Board meeting of MISTRA yesterday, another large program in the Biotech/Life Science field was granted: “Mistra Biotech - More food with less environmental impact”, 40 million SEK to SLU (Swedish University of Agricultural Sciences). In addition to the natural science part of the project (where Biotech related issues could always be interesting for the Life Science sector as well) the project will also include social science issues such as ethics, consumption patterns, regulatory developments, and improved collaboration between the public and private sector. All of those issues could of course be of interest also for the Life Science sector, e.g. when it comes to implementing green pharmaceutical product criteria and economic incentives (to read more on that particular issue, see my blog post from Sept 20 and the links within that blog post).

Postat av Bengt Mattson

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Environmental aspects and the reimbursement system

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I have written several blog posts during the last year on the topic of environmental considerations and the pricing and reimbursement system (see for instance the blog posts from March 28, May 11, May 17, and Sept 1). I have also given my comments on the proposal from Swedish MPA to include environmental requirements in GMP (Good Manufacturing Practice). To read more on the proposal itself, and my concerns (e.g. extremely timeconsuming process) see these blog posts (Dec 16, 2009 and June 16, 2011).

Yesterday on SvD’s Brännpunkt, TLV’s (the Dental and Pharmaceutical Benefits Agency) Director General Gunilla Hulth-Backlund and her colleagues Magnus Thyberg and Martin Forsberg, discussed the generic reform in general and slightly touched upon the issues of potential environmental impacts from pharmaceuticals:

“Apoteksbranschen menar också att utbytesmodellen leder till att vi får läkemedel som tillverkats utan miljöhänsyn. Stämmer det?

TLV vill gärna bidra till att vi får mer miljövänliga läkemedel, men kan inte se att vi skulle få det just genom att införa ett annat utbytessystem. För miljöns skull är det bäst att lösa miljöfrågan på EU-nivå, när läkemedel godkänns för försäljning. Det är också Läkemedelsverkets förslag som man nyligen lämnat till regeringen.”

Based on this quote it looks like TLV would prefer regulatory changes on the EU-level rather than changes of the national pharmaceutical system, such as the mandatory change at the pharmacy desk to the cheepest generic. I cannot really tell whether the regulatory changes they refer to include the GMP-proposal or actually the incorporation of the ERA (Environental Risk Assessment) in the risk/benefit assessment when decisions on market authorizations are made. Nevertheless, I still believe changes in the national system is the right thing do to, and it is to show leadership in this field to take actions also in areas where Sweden can make their own decisions, i.e. allow for environmental considerations also within the framework of the reimbursement system. To only work for changes on the EU-level  is not to take full responsibility - in the worst case, nothing would ever happen to be honest. As I have said previosuly - it is a very timeconsuming process.

I am looking forward to the upcoming discussions with TLV and other stakeholders regarding the reimbursement system and environmental aspects. Next meeting will take place on September 28, when stakeholders including TLV meet at LIF (the Swedish Association of the Research Based Pharmaceutical Industry) for next meeting in the “round-table sessions” (first meeting was held March 28).

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Expert groups to the All Party Committee on Env Objectives

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Today a new phase started in the work process of the All Party Committee on Environmental Objectives (in Swedish: Miljömålsberedningen). There has been a number of meetings with the All Party Committee (parts of the committee or the whole committee) previously where I have had the opportunity to participate (see blog posts from Sept 2, June 15, June 7, and June 2). And today we had the first meetings in the Expert Groups, supporting the All Party Committee in their work on the objective “A Non-Toxic Environment“. There are three expert groups, working in three different areas which have been identified as being of specific interest to the All Party Committee:

- Environmental Impact from Pharmaceuticals

- Hazardous substances in food

- Hazardous substances in goods and products (including cosmetics and hygiene products)

I am a member of the pharmaceutical expert team. The group consists of representatives from several stakeholders, e.g. ministries and agencies, industry, academia, county councils, and pharmacies. The kick-off of the work today became an interesting discussion. Every member of the team described his/her perspective on the topic Pharmaceuticals and the Environment. Although many of us pinpointed the same ongoing initiatives within the area, priorities could vary and we do have somewhat different perspectives on the initiatives (as could be expected bearing in mind our different affiliations). Examples of the initiatives discussed today:

- The initiatives on pharmaceuticals and the environment discussed in the National Pharmaceutical Strategy

- MistraPharma, which will be extremely important to provide knowledge and understanding of environmental impact, but also to learn more on appropriate waste water technologies.

- Economic incentives for green pharmaceuticals (read more in blog posts from e.g. March 28, and Feb 23), and the work to find relevant green criteria possible to use in a model for certifying green products (read more in my blog posts from Sept 1, May 17, and May 11)

- Swedish MPA’s proposal of inclusion of environmental requirements into GMP (Good Manufacturing Practice) (read more in e.g. this blog post: Jan 5)

- Environmental classification of pharmaceutical substances on fass.se

As you may have seen in the end of my blog post from Sept 1, I think there are two key issues worth remembering:
1. Never deny a patient valuable medical treatment due to environmental reasons. Patient safety shall always come first.
2. Possibly the most important thing the All Party Committee on Environmental Objectives could do regarding pharmaceuticals and environment is actually to secure that the “right political signals for action” are being sent, so the initiatives outlined above really happens!

One important task for the expert group in the months to come (the work shall be ready in February 2012) is to try prioritizing between the different initiatives and identify where political actions are most crucial. We shall also propose milestones (measureable and with dead lines) to facilitate implementation of the initiatives/strategies. It will be a very interesting work!

I have to say that I find it extremely fun, fascinating, and positive that the discussions on pharmaceuticals and the environment finally receive such high political interest. I have worked in the field since the 90′ies, and finally we start to see some real interesting progress. Soon we might see green pharmaceutical products in the pharmacies, and a government that actually gives green incentives to the “good actors” and the “good products” in this sector. Sweden has a clear opportunity to show leadership here. The coming 6 months will be so interesting!

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In less than a week - the political summit in Almedalen

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Visby, Gotland

Visby, Gotland

This Sunday, July 3, the political summit in Almedalen starts and runs until July 10. Personally and professionally I find the week in Almedalen (in Visby at the Island Gotland) extremely valuable. It gives almost unlimited opportunities to meet colleagues from both within and outside your sector, to visit high-quality seminars, participate in discussions, and to be honest also to enjoy life.

Pharmaceuticals and the environment - from last year

Pharmaceuticals and the environment - from last year

Review my reflections from the Almedalen week 2009 and 2010 via the following links in order to get a better understanding of the open and pretty informal types of meetings and discussions taking place in Almedalen:

- July 5, 2010

- July 6, 2010

- July 7, 2010

- July 8 and 9, 2010

- June 29, 2009

- June 30, 2009 (day 2)

- June 30, 2009 (day 3)

- July 2, 2009 (day 4)

- July 2, 2009 (day 5)

As you see, a broad range of different topics are discussed, and I will come back during this week with some examples of interesting seminars I recommend you to visit. If you do not have the opportunity to be in Visby next week, then I suggest you follow my blog where I will give you my reflections from seminars and meetings.

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All Party Committee on Environmental Objectives

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Today we had yet another meeting regarding the review of the Swedish National Environmental Goals, i.e. Miljömålsberedningen. You can read my reflections to the previous seminars/meetings on my blog posts from June 2 and June 7. The meeting today was hosted by the Confederation of Swedish Enterprise and the focus of the morning session was the environmental goal “A Non-Toxic Environment” where pharmaceuticals and the environment is a clear focus area. There were participants both from companies (myself and Helena Wadsten from AstraZeneca representing the pharma industry), there were politicians (e.g. Roger Tiefensee) and experts (e.g. Klas Sundberg and Inger Strömdahl) from Miljömålsberedningen and of course representatives from the office of Miljömålsberedningen (e.g. Marie Uhrwing and Sara Sundgren). And guess what - today I learned that the correct English translation of Miljömålsberedningen is “All Party Committee on Environmental Objectives”.

We had a good discussion about how work will develop over the coming years. The All Party Committee has an assingment until 2020 - that is quite some time. The task for the committee is to review how the national environmental goals could be met in a cost efficiant way from society’s perspective. And strategies should be developed in areas where political tradeoffs might be necessary. One of the areas where the all party committee has been requested to develop a strategy is around pharmaceuticals and the environment.

I gave a presentation covering the development of the issue of pharmaceuticals in the environment from roughly ten years back in time, up to all different initiatives ongoing in the field today. To get information on the different initiatives ongoing see my blog post from yesterday. My key message was that it is important to secure that the development of a strategy for pharmaceuticals and the environment builds on all the present good activities performed in open and transparent discussions with all relevant stake holders, for instance the discussions initiated by LIF’s round-table meetings to discuss green criteria and green economic incentives.

Postat av Bengt Mattson

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