Pfizers miljö- och ansvarsblogg

More on the new Swedish PiE data…

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On January 10, I gave some comments here at the blog to the press release and report regarding IVL’s, Umeå University’s, and Swedish EPA’s new data regarding pharmaceutical residues in incoming waste water to waste water treatment facilities, in the effluent from those facilities, and in receving water bodies as well as in some cases also in fish. The study is “breaking news” in today’s issue of one of Sweden’s most influencal science and engineering weekly news magazines, NyTeknik. Ny Teknik presents, in addition to a very similar discussion as was found in the original press release, also an interesting article on new waste water treatment technology experiments at Sjöstadsverket performed by scientists from IVL and KTH.

One thing that I also want to comment is that both on the front page of the NyTeknik newspaper that arrived in my mailbox this morning as well as on their website, another news article regarding pharmaceuticals is highlighted just next to the worrying news about presence of pharmaceutical residues in the environment. But this article is presented in a very “positive” way: “Take a pill - and skip your work-out training”. “The work-out pill is soon a reality“…

I do often find it somewhat disturbing that reports about pharmaceuticals are either “scary alarms” or “magical innovative news”. It has however rarely been as clearly shown as on the front page of today’s NyTeknik… I would prefer a more balanced discussion, both regarding the worrying reports as well as the promising innovations. Life is very rarely completely black or white!

News re Pharma and the All-Party Committe on Env Objectives

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The expert group on Pharmaceuticals and the Environment, working to support the All-Party Committee on Environmental Objectives, met last Friday for a final discussion on the recommendations for objectives to be delivered to the All-Party Committee. I participate in the discussions representing LIF (the research-based pharmaceutical industry in Sweden) and I have to say that I really feel that the discussions have been open, honest, interesting and sometimes challenging. Exactly as it is supposed to be when different stakeholders meet!

Pretty much the same topics as were discussed on our meeting on November 14 were on the agenda now, and the final wording of the different proposals for objectives are being laborated upon. We will now all receive a final draft of the report including all proposed objectives allowing for our final comments. On February 1, the chairperson of the expert group, Christina Rudén, will give a presentation to the All-Party Committee. It will be very interesting to see what will remain unchanged, what will have been altered to some extent and what might even have been deleted completely when the All Party Committee publish its final report regarding the environmental objective “A Non-Toxic Environment” on June 15…

Stay tuned… This document, together with the outcome from ongoing environmental initiatives such as the ones in the National Pharmaceutical Strategy, will be very important to set the “Pharmaceuticals and the Environment” agenda for the coming years.

Pharmaceuticals in the Environment - some new Swedish data

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A press release was issued yesterday from IVL Swedish Environmental Research Institute, in collaboration with Umeå University and the Swedish Environmental Protection Agency, regarding a study on pharmaceutical resudues, from 101 active pharmaceutical ingredients (API), in water. The study has also been commented upon in several news media, e.g. Dagens Apotek. The study looks upon incoming waste water to waste water treatment facilities, on the effluent from those facilities, and on concentrations in receving water bodies as well as in some cases also the concentration of APIs in fish (perch).

The results show that 92 out of 101 APIs could be detected in incoming waste water, 85 APIs were found in treated effluent leaving the treatment plant. 23 APIs were also found in fishes investigated and 26 APIs were found in drinking water.

Jerker Fick, at Umeå University, says to Dagens Apotek that the identified concentrations in drinking water are extremely low compared to therapeutic doses. Hence, there is no known risk for humans consuming drinking water. The study however states that the concentrations of some of the APIs in surface water could potentially impact water living organisms such as fishes.

As has been discussed for several years now, the type of impact, the degree of that impact to water living organisms, and potential consequences (especially on an ecosystem level) are however not known. I hope that MistraPharma and similar research initiatives could help us to understand these matters better, and also help society to identify, and specify, any potential further investments in the waste water treatment facilities.

Jan Christiansson, at the Swedish EPA, states in the press release that in addition to upgraded waste water treatment plants there is also a need for industry to design the APIs in a more “environmentally adapted” way, hence for instance allowing for faster biodegradation of the substances. I have commented on this matter of “green design” previously and I couldn’t agree more in principle, however huge difficiulties exist… It is not an easy task for our scientists to both make substances with good therapeutic effects, without severe adverse health effects, and simultaneously perfectly control the degradability. The substance should not degrade until it has given it’s intended medical effect, but preferentially directly afterwards. Not easy, but something industry tries to accomplish…

So I agree with Jan Christiansson that upgrades of certain waste water treatment plants will most likely be necessary, but we should also never forget to strongly communicate to the public, to all users of pharmaceuticals, that un-used medicines should never be thrown into the toilet! Un-used medicines should be brought back to a pharmacy for controlled disposal.

Action Item 7.2 in the National Pharmaceutical Strategy

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Yesterday I participated in a conference arranged by the “County Council Network on Pharmaceuticals and the Environment” (in Swedish: Landstingens nätverk för Läkemedel och Miljö). This was the third conference arranged by the network (see my comments from last year’s conference via this link).

I had the opportunity to participate in the morning session which started out with Åke Wennmalm (SustainPharma and previously the Environmental Director at Stockholm County Council) describing a 10-year long journey with Pharmaceuticals and the Environment. There is a lot of things that have happened in the last decade!

After Åke, Nina Viberg from SKL entered the stage and she described some ongoing initiatives, e.g. the National Pharmaceutical Strategy and the All-Party Committee on Environmental Objectives. You can read more about these initiatives in my blog post “A Regulatory Update on Pharmaceuticals and the Environment“.

Nina passed the word over to me, and I went in to some more details on the environmental action items (especially items 7.1 and 7.2) in the National Pharmaceutical Strategy:

7.1. Investigate if the environmental aspects should be considered when decisions on subsidy for a pharmaceutical are decided (Lead: Ministry of Health and Social Affairs): Review of possibilities to – within the context of the national reimbursement system - increasingly take environmental considerations.

7.2. Encourage voluntary control of emissions from pharmaceutical factories (Lead: LIF): Introduction of a voluntary environmental labeling of pharmaceutical products.

As you will know from my previous blog posts, I will be the project manager for action item 7.2 and will hopefully be able to connect 7.2 strongly with action item 7.1 which is to be managed by Sofia Wallström in her review. I think it is very important, and it feels reasonable,  that society presents some form of economic incentives if industry is supposed to “volontary implement a system and an assessment model”… I described the work that has been made so far to develop a assessment model by the task force initiated by the LIF Round Table (see the blog post from Sept 28 and follow the links within that blog post for more details).

For the first time I also showed a draft project plan for the “action item 7.2 work task”. As you notice, it is still a draft but it will soon become more formal and official…

Draft project plan...

It might be hard to read but in essence it has four deliverables:

1. An e-learning tool to educate and train colleagues: “What is a green pharmaceutical, and how do you assess grenness?”

2. Development of a model for environmental assessment of pharmaceuticals, with clear criteria to identify green products

3. Development of a tool/methodology/connection between the assessment model and green economic incentives within the pricing and reimburesment system

4. Establish of an organisation to handle/manage the models and systems

As you understand there are very important cross references between 7.2 and 7.1 (i.e. the Sofia Wallström review if environmental aspects can be taken within the frame of the pricing and reimbursement system)!

More to come - stay tuned!

Sofia Wallström to review green incentives & reimbursement

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It has been announced today that Sofia Wallström, who used to work at the Ministry for Health and Social Affairs, will review how environmental considerations can be taken within the context of the national reimbursement system. This is a task I have highlighted previously in my comments on the National Pharmaceutical Strategy (see for instance my blog post from Aug 28) and action item number 7.1 in the strategy:

“7.1. Investigate if the environmental aspects should be considered when decisions on subsidy for a pharmaceutical are decided (Lead: Ministry of Health and Social Affairs)
Review of possibilities to – within the context of the national reimbursement system - increasingly take environmental considerations.” (unofficial rough translation provided by LIF, the Association of the Research Based Pharmaceutical Industry in Sweden).

I am happy to see that Sofia Wallström has been appointed, but I am somewhat concerned about the fact that her task is huge and complex. The review of green incentives and the reimbursement system is just one part of a huge review Sofia has been appointed to do. Read the full task via this link. Sofia’s work is to be presented not later than Sept 1, 2012. I really hope that important parts around green incentives and the reimbursement system can be communicated earlier and at least worked with in parallel to Sofia’s work. If you have followed  my blog you know that all relevant stakeholders will meet at LIF next Wednesday, Sept 28 (read about some of the background to that meeting via this link), to discuss this issue. I believe a lot of good and valuable input for Sofia Wallström’s review can be available already after that meeting.

The environmental part of the work commissioned to Sofia Wallström reads as follows (in Swedish):

“Miljöpåverkan av läkemedel, både original och generika, kan delas upp i miljöpåverkan genom produktion respektive konsumtion av läkemedel. Läkemedelsverket påpekade i sin rapport från 16 december 2009 ”Redovisning av regeringsuppdrag gällande möjligheten att skärpa miljökrav vid tillverkning av läkemedel och aktiv substans” att den svenska läkemedelsindustrin sedan många år arbetar med frågan om att minimera sina utsläpp av farliga ämnen till vatten. Utsläpp från produktionsanläggningar av läkemedel i Sverige är mycket begränsade då de ofta har egen avloppsrening för sina utsläpp. Den svenska läkemedelsproduktionen är också noga reglerad och kontrollerad. Sverige har i dag en begränsad produktion av läkemedel varför den huvudsakliga utmaningen för vår närmiljö utgörs av konsekvenser av läkemedelskonsumtion.

Utvecklingen under senare år är dock att läkemedelsföretagen i Sverige lägger ut mer och mer av sin produktion till lågprisländer där miljökraven vid tillverkning antingen är avsevärt lägre än i Sverige eller där myndigheternas möjligheter att övervaka efterlevnaden av de nationella miljökraven är begränsade. Stora delar av produktionen sker i bl.a. Kina och Indien.

TLV har i sin praxis inte vägt in miljöhänsyn vid beslut om ett läkemedel ska ingå i läkemedelsförmånerna. För att TLV ska kunna göra detta behöver det bl.a. finnas tillräckliga kunskaper om läkemedels påverkan på miljön, möjligheter att kvantifiera kostnaderna för de negativa miljöeffekterna samt ett obligatoriskt system för miljöklassificering där läkemedel är bedömda utifrån gemensamma kriterier.

När det gäller miljöpåverkan genom konsumtion visar erfarenheter från apoteken och ett flertal studier att mängden läkemedel som hämtas ut på apoteken men inte konsumeras är betydande. Kunskapen om hur mycket läkemedel som inte används eller kasseras på annat sätt än att återlämnas till apotek är mycket begränsad.

Då patienter inleder behandlingar med ett nytt läkemedel krävs ofta en inställningsperiod för att få en optimal dosering av läkemedlet. Om biverkningar uppträder kan det bli aktuellt att byta preparat. Det är därför en fördel om patienten inledningsvis kan få en mindre förpackning (startförpackning) utskriven.

När det gäller tillgången till små läkemedelsförpackningar är det läkemedelsbolagen som väljer vilka förpackningar de vill introducera på den svenska marknaden. Vilka förpackningsstorlekar som ett bolag väljer att tillhandahålla kan dock ha ett samband med prissättningen av förpackningarna.

Utredaren ska därför
– analysera och pröva om TLV bör väga in miljöaspekter i förmånsbeslut för samtliga läkemedel, 
– redovisa vilka praktiska förutsättningar som måste vara uppfyllda för att TLV ska kunna väga in miljöaspekter vid förmånsbeslut,
– belysa hur ett beaktande av miljöaspekter vid beslut om förmån skulle påverka läkemedelskostnaderna och hur miljön skulle påverkas i tillverkningsländer utanför Europa, och
– särskilt analysera och pröva om tillgången till små läkemedelsförpackningar kan bidra till minskad kassation av läkemedel.”

I will only comment on one particular thing, in addition to my general appreciation that the review will take place. I do not agree with the opinion stated in the end of the third paragraph above:

“…ett obligatoriskt system för miljöklassificering…” (translated into English: …a mandatory system for environmental classification…)

I strongly believe that a model can be, and will be, developed that could be used by pharmaceutical companies to show that their products are green. And I strongly favor that using the model and applying for “greenness” should be a voluntary action. It should be the decision of the company to develop documentation showing compliance with environmental criteria, and sharing it with an agency such as TLV, and hence “applying for the green incentive”.

There is a very interesting work process ahead of us. I wish Sofia Wallström the best of luck in her work and do of course hope to be able to interact with the review. We now have a possibility to “greening” an entire sector in society. Let’s take that opportunity!