Pfizers miljö- och ansvarsblogg

A Regulatory Update on Pharmaceuticals and the Environment

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The regulatory committee of LIF, the Association of the Ressearch Based Pharmaceutical Industry in Sweden, had invited all member companies to a session on “regulatory updates” today. I participated with a brief presentation on ongoing regulatory initiatives, on an EU level as well nationally in Sweden, in the area of Pharmaceuticals and the Environment.

Since I will start working part-time for LIF on Thursday, December 1 (see my blog post from Oct 19 for more details) I took the opportunity already today to share my “LIF coordinates”:

If you have followed my blog over the recent months, the examples of ongoing regulatory initiatives mentioned by me today will not come as a surprise (see for instance my blog post from June 14 for a summary).

On the EU level I mentioned among others things the WFD, the water framework directive. Ethinyloestradiol (EE2), oestradiol (E2), diclofenac and ibuprofen were initiatlly proposed  as Priority Substances (PS) under WFD. Ibuprofen is taken away from the discussions as far as I understand, whereas there are still discussions ongoing for the other three (although it seems likely that the sex hormones should rather be discussed together with other “potential endocrine disruptors” under another EU initiative). The WFD discussions will continue, and it will be very interesting to see the outcome. Personally I cannot really understand how an EQS (environmental quality standard) 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).

National initiatives of course included

- Swedish MPA’s proposal of including environmnetal requiremenst in GMP (see for instance my blog post from July 19 for comments on the proposal)

- The National Pharmaceutical Strategy, and especially the two first action items identified within the scope of intervention area number 7 “Reduce effects on the environment by pharmaceuticals, locally and globally”:

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.

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”…

- The All Party Committee on Environmental Objectives, and especially their work on the goal “A Non-Toxic Environment” where they have been commissioned to more clearly than before include pharmaceuticals in the scope. See my blog posts from Nov 14, Sept 16, and Sept 02 for more details.

I also briefly mentioned the MistraPharma-project which clearly interacts with all these regulatory initiatives. Read more about MistraPharma on the project website and/or in my blog posts from e.g.  Nov 10, Sept 22, and Jan 18.

Sustainable Development and the Pharma Industry

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I have today, as I do roughly once a year, discussed sustainability programs in the pharmaceutical industry with students at The Ångström Laboratory, Uppsala University. Interesting and a lot of fun!

The Ångström Laboratory

My presentation is part of a course on Environmental Management Systems, so I tried to explain our sustainability programs from the system perspective. Starting out with a general background on why sustainability programs in general, and environmental programs specifically, are necessary. Going into several aspects (or potential problems) that those programs need to address. And then moving over to follow-up and corrections that may be needed to secure environmental improvements over time. The outline is quite similar to the presentations and discussions I regularly do at SLU (see for instance these two blog posts: From March 10, 2011 and from Feb 19, 2009.

To describe the great numbers of environmental aspects that needs to be assessed I used a series of slides where a full picture of aspects are built up step-by-step: From your own manufacturing facility, looking back into your suppy-chain, looking downstream following your products out on the market, and finally of course also adding the R&D-operations to give the full picture. Below you see all the slides condensed into one… Quite a busy slide I have to say…

We had good discussions, and especially during the last 15 minutes when the students were given the task of identifying potential environmental aspects on a made-up company called Juicy Drinks Inc. The students should, based on the knowledge they had recieved on environmental management systems (e.g. ISO 14001) perform an “initial environmental review”. So, which environmental aspects do you think Juicy Drinks Inc has to address?

Perhaps we could get some good interactivity going here. Please provide your suggestions…

I will work half-time at the LIF Office during 2012

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It has now been announced that I will work half-time at the LIF Office (the Association for the Research Based Pharmaceutical Industry in Sweden) from Dec 1, 2011, until Nov 30, 2012. See the announcement from LIF below:

“New to LIF’s Office by December 1: Bengt Mattson

Working half time, in charge of CSR, parts of the national pharmaceutical strategy and committee responsible for the LIF Environmental Committee

The LIF Office further strengthens its resources and tries a new form of operating by borrowing colleagues from the member companies. First up is Bengt Mattson, who is head of CSR and Environmental Affairs at Pfizer, and chairman of LIF’s Committee on Environmental issues. Bengt will work half-time at LIF during the period December 1, 2011 to November 30, 2012 and part-time at Pfizer. Bengt will be the project manager for LIF’s work on part of the National Pharmaceutical Strategy (to “Encourage voluntary control of discharges from pharmaceutical factories”) and he will also have overall responsibility for CSR issues at the LIF Office. Bengt will also be the LIF Office responsible person for LIF’s Environmental Committee and hence leave the function as Chairman during this period.”

I think this will be very interesting. I will as you see in the announcement work on e.g. environmental issues related to the National Pharmaceutical Strategy and also on CSR matters in general. Regarding the environmental issues and the national pharmaceutical strategy, you already know parts of the work which needs to be done if you have followed my blog over the recent months. There are four activities identified within the scope of intervention area number 7 “Reduce effects on the environment by pharmaceuticals, locally and globally”:

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.

7.3. Investigate what further measures can be taken at national level to reduce wastage of medicines or in other ways limit the environmental impact of use of pharmaceuticals (Lead: Läkemedelsverket): Investigation of the causes of wastage and propose measures to reduce wastage of medicines. Implementation of joint information efforts to encourage patients to return leftover medicines.

7.4. Promote the possibilities for environment considerations during production and use of medicines (Lead: Cabinet Office): The Government on June 9, 2011 took the decision (M 2010:04) to give the All Party Committee on Environmental Objectives the additional task of developing a strategy for Sweden’s work in the EU as well as internationally for a non-toxic environment. The strategy should also encompass the impact of pharmaceuticals on the environment.

As you probably understand I will be the project manager for the work related to point 7.2. This project will of course require very close connections to the work described in point 7.1, which to most people is known as “the Sofia Wallström review“. To be successful with point 7.2, it will be crucial that Sofia W comes to the conclusion that environmental considerations should be taken within the framework of the pricing and reimbursement system. Read more about green economic incentives and the pricing and reimbursement system in my blog post from Sept 28.

As you could read in the LIF announcement I will also have an overall responsibility for CSR issues at the LIF Office. The aim will be to develop a CSR platform for the industry association. And actually, a lot of its ingredients are already in place. Important parts of the CSR platform are initiatives such as:

- The ethical rules, with agreements for all collaborations with health care professionals and patient advocacy groups, and a very strong self regulation system with the LIF Compliance Officer, NBL and IGM

- The LIF Policies, e.g. on the use of animals in research and development

- Patient Safety initiatives

- Fass.se, with factual information on pharmaceutical products to health care professionals as well as the public (including the world unique collection of environmental data for pharmaceutical substances)

- The environmental programs

- The Swedish Drug Insurance Scheme

- The initiatives related to the fight against counterfeited pharmaceuticals, including 2D-coding

- Financing of the healthcare system and pharmaceuticals, including “our welfare in the future” and “the healthcare of tomorrow“

- Prevention and health promotion initiatives, such as the ones I have discussed here at the blog previously

- Equal healthcare and access to medicines and adequate healthcare

- The pharmaceutical industry and the developing world, with several good examples as the ones I described here at the blog in October last year (e.g. Oct 24, Oct 21, Oct 20, and Oct 19).

To me this looks very promising. We are doing the right things, but sometimes it seems like we are not able to communicate successfully… I would like our stakeholders to know about the initiatives, and to interactively debate the initiatives with us. I personally of course also believe that we deserve a better reputation than what have been found in several surveys over the years. See for instance the results from the Swedish survey Sustainable Brands, where the pharmaceutical industry was ranked very poorly 2011 (see my comments to the report via this link). But perhaps things have slowly starting to change, at least in certain countries. I was very happy when I read the “Sustainability Leadership Report” from Brandlogic and CRD Analytics. In this survey, virtually all pharmaceutical companies measured are rated Leaders, both when it comes to actual ESG performance (Environmental, Social, Governance) and to perception. The countries covered in the survey were China, Germany, India, Japan, UK, and US. This does look promising! Could a more clear and visible CSR platform help the pharmaceutical industry in Sweden to receive a better recognition and reputation? I hope so, and I hope I can contribute to such a journey through my work at LIF during 2012!

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”!

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!