Environmental aspects and the reimbursement system

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).

Expert groups to the All Party Committee on Env Objectives

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!

In less than a week – the political summit in Almedalen

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.

All Party Committee on Environmental Objectives

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.

Regulatory Update – Pharmaceuticals and the Environment

There are several governmental initiatives, all of them with possible regulatory implications, ongoing here in Sweden regarding pharmaceuticals and the environment. I have today given a brief presentation to LIF’s Regulatory Affairs Committee summarizing these initiatives and also briefly discussed the potential impacts from the EU Water Framework Directive. LIF is the association for the research based pharmaceutical industry in Sweden.

There are three ongoing governmental commissions and/or initiatives:

- The work by Swedish MPA regarding the inclusion of environmental criteria in GMP (Good Manufacturing Practice). I presented the commission here at the blog on Jan 5, 2011, and have mentioned it several times since then, e.g. May 20, March 28, Feb 18. As you probably know, LIF’s position on this is that we like to participate in the process, but we do however believe it is a very long and slow process… It will probably take at least 10 to 15 years to make environmental additions to GMP, and quite frankly given the problems existing for instance in India from manufacturing releases of pharmaceutical substances, we do not have the time to wait that long… We believe more could be done faster through other mecahnisms, e.g. economic incentives for green pharamceuticals.

- The Swedish National Pharmaceutical Strategy. One of the objectives in the strategy is ”minimal negative environmental impact from pharmaceuticals”. The strategy document will be published during summer and several actions and initiatives are expected to follow. I expect to see both connections to the GMP-discussions but also to the discussions on green criteria and green incentives. I have written several blog posts lately regarding green criteria and incentives which I believe are crucial for success. See for instance the posts from March 28, April 20, May 11, and May 17.

- Miljömålsberedningen, which could roughly be translated into ”the Review of the Swedish National Environmental Goals”. One of the environmental goals being under review is ”A Non-Toxic Environment”. Our government seem to have a clear view that ”pharmaceuticals” should be more clearly expressed and discussed as part of this ”chemical control goal”. See my blog posts from discussions earlier this month, June 2 and June 7.

I strongly believe it is extremely critical that these different governmental initiatives are well coordinated. One initiative to secure this was the invitation to LIF’s ”round-table-discussion” that went out to all relevant stakeholders in March. See my comments from the meeting held on March 28. Several discussions and meetings will follow, for instance a meeting at the Confederation of Swedish Enterprises tomorrow regarding the review of the goal ”A Non Toxic Environment”, and another meeting with the full round-table group on September 28. Stay tuned…

And we will of course also be affected if the EU Water Framework Directive (WFD, Directive 2000/60/EC) would include any pharmaceutical substances on e.g. the so called Priority Substances list. The WFD establishes a framework for the protection of inland surface waters, transitional waters, coastal waters and groundwater. One means of doing this is by identifying Priority Substances (PSs) for control of emissions, including environmental quality standards (EQSs) in particular water compartments. EQSs are maximum allowable concentrations in the designated compartments and member states are responsible for their achievement and monitoring. The WFD also provides for designation of certain substances as Priority Hazardous Substances (PHSs) – emissions to water of these substances have to be phased out over 20 years.

Discussions are ongoing regarding a handful of pharmaceutical substances:

- ethinyloestradiol (EE2), oestradiol (E2), diclofenac and ibuprofen as potentially to be proposed as PSs

The WFD discussions will definitely continue, and it will be very interesting to see the outcome. Personally I cannot really understand how an EQS set for a pharmaceutical substance will relate to a market authorization granted through the pharmaceutical regulations. If the EQS is surpassed in a water body, would that imply that no more such substance could be released into the water body. And if so, wouldn’t that in reality mean ”no more usage” (due to the simple fact that the publicly owned waste water treatment plants still cannot remove all excreted pharmaceutical substances from patient use)… Once again – stay tuned, more to come!