Pfizers miljö- och ansvarsblogg

Green Chemistry in the Pharmaceutical Sector

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As you might have seen in the end of my blog post from yesterday, I have discussed Green Chemistry, Design for the Environment, and other issues in the field of pharmaceuticals and the environment today. And I have had those discussions on a train running from Uppsala to Gothenburg. That was a new experience for me I have to admit. Fun, but slightly unstable. I should probably have worn a helmet to secure that I did not hurt myself if I would have fallen to the floor… But it went well!

Discussing sustainability

My discussion partners were coming from a urology conference (”Urologidagarna”) in Uppsala and heading back home to Gothenburg. A pretty good thing I would say to combine the train trip with some green pharmaceutical discussions (at least in my view)!

I gave a general background to environmental issues in our sector, starting with one of my favourite slides: The Sustainable Quadrant that I have borrowed from Stina Billinger (Storebrand/SPP).

The Sustainable Quadrant

I then discussed both Access to Water issues as well as Climate Change and Energy matters before jumping into Pharmaceuticals in the Environment. We looked into both green design or Design for the Environment, i.e. how to design the active pharmaceutical ingridient to allow for low toxicity, no bio-accumulation potential, and easy degradability. I also gave example upon Green Chemistry perspectives on manufacturing operations, i.e. lowest possible use of raw materials, low toxicity of the solvents and materials used, and as small generation of waste as possible.

In the end of the presentation we discussed releases of pharmaceuticals susbstances from manufacturing facilities. Part of the discussion of course concerned Joakim Larsson’s results of releases in Hyderabad, India. In the discussion I talked about the ongoing discussions on green incentives in the pricing and reimbursement system as one tool to address those kind if issues. For more details on green incentives see the blog post from Sept 28 for instance.

It was really fun having these discussions on a shaky train to Gothenburg!

Sustainability and the Pharmaceutical Sector

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PharmaPortalen and Pharma Online arranged the seminar “Läkemedelsmarknadsdagen 2011” today, focusing sustainable development in the pharmaceutical sector. They had invited a number of speakers representing the industry as well as agencies, but also academia and journalists. A good mixture of perspectives. Jonny Sågänger, Pharma Online’s Editor, introduced the day by giving definitions of sustainability and CSR (Corporate Social Responsibility), and by spelling out the main questions for the day: What are the drivers for CSR-initiatives? Does CSR provide business opportunities and/or risk minimization? How strong are the demands from internal and external stakeholders?

Jonny Sågänger gives an introduction

First speaker was Magnus Thyberg from TLV (the Dental and Pharmaceutical Benefits Agency). TLV has been in focus for, and they have participated in, several discussions lately regarding green pharmaceuticals and green incentives, e.g. yesterday’s round-table meeting at LIF. See also my blog posts from Sept 20 regarding TLV and green incentives in the reimbursement system. As is obvious in the Sept 20-blog post, TLV does not seem to have green incentives as their top proposal for addressing potential environmental impacts from pharmaceuticals. The rather tend to promote MPA’s GMP-proposal. TLV’s objections to introducing green incentives in the pricing and reimbursement system is that the Swedish market is too small. I would rather say that it is “small or big enough to be used as a perfect case study”.

Magnus Thyberg and the pharma strategy

And Magnus gave of course also some insight into the possibilities that TLV does see of introducing green incentives. What will happen is hard to tell, but we will for sure follow Stina Wallström’s review of green incentives and the reimbursement system with great interest. Magnus gave a brief description of the work task Sofia W has in front of her.

Charlotte Unger

Charlotte Unger from MPA entered the stage after Magnus. Charlotte discussed the three main proposals from MPA’s report in Dec 2009:

- Environmental requirements in GMP (Good Manufaturing Practice)

- The ERA (Environmental Risk Assessment) as a part of the risk/benefit analysis when making decisions on market authorization

- A review of the pricing and reimbursement system to allow for green incentives

You already know my preference here. I strongly believe that green incentives is a much faster, and a more efficient way, to “greening the sector”.

Charlotte also gave brief comments to the work on pharmaceuticals and the environment in the work process of the All Party Committee on Environemntal Objectives.

Anita Finne-Grahnén from LIF (the Association of the Research Based Industry in Sweden) then gave us a short descriptions on CSR initiatives at the industry association level. She focused the LIF initiative to environmentally classifying active pharmaceutical ingridients, and publish the information on fass.se, and the very developed ethical regulations which governs all our business operations.

Anita Finne-Grahnen from LIF

I think the ethical rules are a very good example of very valuable CSR-efforts. We should as an industry be very proud of these rules. It secures that our business are conducted properly, without any “corruptive” ingridients. We should however be much better to communicate on this. I think large parts of the public still believe that business are done as incorrectly shown in the Hollywood movie “Love and other drugs”… Not strange then, that our reputation in not the best…

Christina Ruden from MistraPharma

Christina Rudén provided us with the perspective from academia. She presented results from the first phase of MistraPharma and also gave some insigths what will come during Phase 2 of MistraPharma, which has recently been granted by Mistra.

Mikael Salo, MiljöAktuellt

After a lunch break we got the opportunity to listen to Mikael Salo’s (editor MiljöAktuellt) perspectives on sustainability and the pharmaceutical sector. Mikael used the results from the Sustainable Brands 2011 investigation to elaborate on the issue. I have discussed those results before (see my blog post from March 22), but although there might be “good explanations” or “good excuses” for the extremely poor result for the pharma industry (at the bottom when it comes to the public’s rating of sustainbility performance), it definitely tells us something…

Sustainable Brands results

We are not good on communication. We need to better “tell our stories”. How should we do to spread information like the one published on pfizer.se regarding CSR and sustainability (a brief introduction, information in somewhat more detail, or detailed information on our sustainability initiatives), or the information on Pfizer’s global webpage regarding sustainability and Corporate Responsibility.

After Mikaels presentation we received two lectures on industry case studies when it comes to sustainability programs.

Zeljko Tucak and APL

First a presentation on APL given by Zeljko Tucak and then about AstraZeneca’s programs (presented by Tove Engström).

Tove Engström and AZ

Two impressive presentations and a number of good examples of industry initiatives. Listening to these examples, it becomes very clear that this industry’s sustainability reputation should be better… Then why isn’t it? I personally believe that we need to communicate more widely, more frequently, more interactively and more transparently. We need to interact with all different stakeholders, through all different types of communication channels. But we also need to decide whether or not we actually want to build our corporate brand or if we will continue to focus upon our product brands. To me there is a very important difference here to bear in mind - when we discuss product brands, we are to a large extent forbidden to communicate with the public, hence very difficult to build a reputation… Corporate brand communication - about our values and non-product related information, can be shared much more freely.

This take us to the last speaker of the day, Tomas Brytting. Tomas also represents academia (from Ersta Sköndal Högskola), and he gave a though provoking lecture on CSR, on stakeholder engagement and dialogue, and what actually drives CSR-initiatives. He was very clear that he doubted that “economic profitability” was the only reason to work with social responsibility issues such as human rights. And of course he is right. The values embedded in our corporations do play a significant role in these programs!

Tomas Brytting

The seminar ended with a panel discussion where I and some of the speakers of the day discussed and further elborated on CSR inititives, CSR drivers, and what will happen in the coming years. I think I can say that everyone agreed that CSR (both social and environmental sustainability) is a key to success, and that it will grow more and more important over the coming years. To some extent of course it is embedded in the values of the corporations, and should of course definitely be so in an industry working for a healthier world. But financial opportunities are also important. This takes me back to the issue of green incentives… I really hope to see green incentives in the reimbursement system. That would help to further develop the sustainability programs in the industry!

This was a good and interesting seminar. I should probably give you more details from the discussions, but I am rather tired now. Time to go to bed and get some sleep. There is another work-day coming up tomorrow. I’ll be on a train to Gothenburg discussing environmental sustainability with some stakeholders, but more on that later…

A Round-Table Discussion on Green Economic Incentives

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You may know based on my recent blog posts (e.g. Sept 20) that a round-table discussion regarding green pharmaceuticals and green economic incentives took place today at LIF (the Swedish Association of the Research Based Pharmaceutical Industry) with pretty much all relevant stakeholders present.

Participant list and notes

Represented parties in addition to LIF and FGL (the Association for Generic Pharmaceuticals) were e.g. MPA, TLV (the Dental and Pharmaceutical Benefits Agency), SKL (Swedish Association of Local Authorities and Regions), Swedish Pharmacy Association, Ministry for Environment, MSR (the Swedish Environmental Management Council), the All Party Committee on Environmental Objectives, LOK (in Swedish: “Läkemedelsordförandekollegiet”), Stockholm County Council, and IVL (Swedish Environmental Research Institute). A very important actor that unfortunately could not make it to today’s meeting was the Ministry for Health and Social Affairs, and Sofia Wallström that they have appointed to review the issue of a green pricing and reimbursement system (see this link for more information).

We started the meeting with a short recap from the first round-table meeting held on March 28 (see my comments from that meeting via this link). We then gave short updates on what had happened on this topic since last meeting in addition to the work of the two task forces that were initiated at the March 28 meeting. We briefly discussed both the latest developments on MPA’s GMP-proposal (see for instance my blog post from July 19), the National Pharmaceutical Strategy (see for instance my blog post from Aug 28), and the All Party Committee on Environmental Objectives (see for instance my blog post from Sept 16).

The most interesting part of the meeting was nevertheless the updates from the two task force groups which were kicked-off at the meeting on March 28. One group to develop a model for environmental assessments of pharmaceuticals, to be used to identify green pharmaceuticals. Another group to evaluate possible green incentives within the framework of the Swedish pricing and reimbursement system.

Since I have been part of the group developing a model for assessments you probably already know parts of our discussions from previous blog posts (see blog posts from March 28, May 11, May 17, and Sept 1). The incentive group also presented a very good and interesting work. They had looked into models both for incentives around products being off-patent and exposed to generic substitution, and for pricing and reimbursement discussion with an agency such as TLV for new products. I will not go into any details here since more analysis and evaluation is needed but if you have really good eyes you may find some details here in my notes…

My notes from today...

Next steps will be, as I said, more in-depth analysis and evaluation of the models (both the model for assessments, and the models for incentives), but of course also securing that the discussions and thoughts very briefly presented here is taken to the All Party Committee on Environmental Objectives for their future work, and of course to Sofia Wallström in her coming work. We have come quite far already! It is very promising, and I think we should be very proud of the very productive and fruitful progress we have done in a close collaboration between all different stakeholders in the pharmaceutical sector!

Let’s keep up the good work and thereby doing what we can to “greening the sector”!

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!

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).