Pfizers miljö- och ansvarsblogg

MPA report on GMP and environmental requirements

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I have written about Swedish MPA’s governmental commission regarding GMP (Good Manufacturing Practice) and environmental requirenments several times here at the blog. And today, the MPA report on their commission was issued. See the press release via this link and the report in pdf via this one.

The report does not present any surprises. MPA suggests as expected that GMP can and should be revised/amended to include environmental requirements. In more detail, MPA suggests four actions to be taken (quotes in Swedish from the report):

“1. Ändringar i läkemedelsdirektiven
I läkemedelsdirektiven lägga in en skyldighet för tillverkare av läkemedel att följa kraven i en särskild rättsakt, en ny EU-förordning (se punkt 2 nedan), där utsläppsnivåer för vissa substanser anges. Den nya skyldigheten bör i läkemedelsdirektiven läggas i kravet på att uppfylla GMP vid tillverkning

2. Införandet av en ny EU-förordning
En ny EU förordning bör utformas. Utgångspunkten för förslaget med en ny rättsakt är att i denna ange de läkemedelssubstanser som behöver kontrolleras samt de utsläppsnivåer vid tillverkning som inte är godtagbara. För att hitta en bra struktur kan man titta på hur kosmetikalagstiftningen inom EU är konstruerad

3. Förslag på ämnen som bör prioriteras
Det som i ett första steg bör prioriteras i ovan nämnda EU-förordning är läkemedelssubstanser för vilka det finns ett vetenskapligt stöd för att den yttre miljön, och därmed folkhälsan, påverkas negativt.  Detta gäller framförallt antibiotika, vissa läkemedel med hormonstörande ämnen samt substanser som genom att de används och tillverkas i stora volymer kan innebära en risk för miljön

4. Arbete med att identifiera ytterligare kandidater
I den nya EU-förordningen bör ett förfarande fastslås för hur ytterligare ämnen ska identifieras och hur koncentrationsgränser ska sättas.  Dessa uppgifter kommer att behöva utföras av något organ inom EU som har relevant miljökompetens.”

I will just make a few first gereral comments here, I presume that I will come back to this issue many times in the future.

First of all, I think it is a fairly long process to make the changes proposed. I am somewhat surprised to read Charlotte Unger’s (Environmental Manager at MPA) comment in the press release that this “can be implemented relatively fast”. I still believe it will take at least ten years. And as I have said previously, we cannot wait ten years to secure processes that put an end to the situation described for instance in Hyderabad in India by Joakim Larsson and his co-workers. Hence I am convinced that the GMP regulatory initiative needs to be supplemented with other measures, e.g. green economic incentives (read more via these links: March 28, May 11, and May 17). Measures that can be implemented more rapidly.

Secondly, I am also convinced that alterations in the pricing and re-imbursement system to enable green incentives would possibly reach longer than MPA’s proposed changes to GMP. MPA talks about specific type of pharmaceutical products, i.e. antibiotics and sex hormones, while economic incentives for green products would most likely create initiatives from industry in all different classes of substances and products.

As I have already said, I will come back to this topic. Discussions will be intense in the months to come. Stay tuned!

Regulatory Update - Pharmaceuticals and the Environment

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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!

Årets Kvinnohjärta (”Woman’s Hearth of the Year”) 2011

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I am so proud! Yesterday I was honored the award “Årets Kvinnohjärta 2011″ (roghly translated to Woman’s Hearth of the Year 2011) by Sollentuna Kvinnojour (”the Women’s Shelter in Sollentuna Municipality”) from the hands of their chairperson Maria Nettersand.

Maria Nettersand and I

Pfizer has collaborated with the Sollentuna Kvinnojour for two years now. The ultimate vision for the collaborative work is to find a 100% completely secure process, with guaranteed confidentiality, for mistreated and battered women to find adequate treatment within Swedish health care. Their identities or where they are being treated must not ever be revealed to anyone. If that happens, and yes it has happened, these women and their children could often be brought back to the hell they managed to escape from…

I am so honored to have received the award “Årets Kvinnohjärta 2011″ and very touched and almost embarrassed over the way the nomination was worded:

Sollentuna Kvinnojour tilldelar

Bengt Mattson

utmärkelsen

ÅRETS KVINNOHJÄRTA 2011

I sin roll som CSR-ansvarig på Pfizer AB har Bengt uppvisat ett starkt engagemang för alla människors lika värde och för att alla människor har rätt till att leva ett liv utan våld.

Genom att gå utanför den traditionella synen på företags sociala ansvar har Bengt låtit Pfizer bli en föregångare som vi på Sollentuna Kvinnojour hoppas att många skall följa.

Bengt som person uppvisar stor empati och civilkurage. Han har en humanistisk människosyn och arbetar aktivt för att alla människor är värda att få samma möjligheter i livet. Bengt är helt enkelt en god person med ett stort hjärta som okar och vågar stå på våldutsatta kvinnors och barns sida.

I wish to once again express my deepest gratitude to Sollentuna Kvinnojour for the award. I am very proud and honored! And thanks to Anki Elken for taking the picture above. A valuable memory!

Earth Hour 2011

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So, yesterday we all experienced Earth Hour 2011.

As you know by now (see my previous blog posts from Monday, Tuesday, Wednesday, Thursday, and Friday) I am a big fan of WWF’s manifestation and support for the fight against climate change. I recommend you to see all nice pictures on WWF’s webpage documenting how people all around the world participated.

I was first outside our office in Silverdal in Sollentuna watching the lights go off.

Our office with lights on...

To be honest I am always somewhat disappointed - it does not get as dark as I would like to see it. For good reasons though, there are a lot of emergency and security lights that remain switched on.

Lights switched off...

In a close up it is even more obvious that there are quite a few security/emergency lights in an office of this kind.

The entrance area with lights on...

As you see, several lights remain switched on, but nevertheless - the message is clear: We support the manifestation!

Entrance area during Earth Hour...

I then went home to enjoy some cosy Earth Hour experiences with candels, some wine and my violin.

Candels, wine and a fiddle

It was just so nice. I should arrange my own little Earth Hour more often! It was a cosy feeling sitting there playing my violin in the light from candels, sipping on ecological red wine. And the discussions regarding global warming I had earlier on during the day with my son filled me with great hope. He and his friend celebrated Earth Hour together with discussions in the light of candels. There is hope for change!

Candels give that cosy feeling

Pharma Network, Pharmaceuticals and the Environment

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Today I gave a presentation at a meeting with Pharma Network. In the invitation to the network meeting, Jonny Sågänger and Kristofer Petraeus from Svenska Nyhetsbrev who runs the network, had written the following (in Swedish, sorry to you non-Swedish readers):

“Välkommen till nätverksträff i Pharma network!

Läkemedelsindustrin och miljöfrågorna

Möt Bengt Mattson från Pfizer och LIF, utsedd till Årets Läkemedelsprofil 2009 för sitt mångåriga arbete med att föra in miljö som ett allt viktigare område på läkemedelsindustrins agenda.

Bengt ger en bred och generell bild av branschens och industrins syn på miljöfrågorna. Hur långt har vi kommit i dagsläget och vad är möjligt framöver? Vilka möjligheter och begränsningar finns det i miljöarbetet?”

I guess you know by now if you follow my blog that I really like to give presentation such as this one, but I have to say that I had mixed feelings going in to Stockholm city today. My father had a stroke just before the weekend and he is at the hospital in a coma. But I felt I needed a break, and this was perhaps just what I needed today…

Sustainable Development presentation

I called my presentation “Sustainable Development - a core element of strategic business development”, and my message was that environmental sustainability as well as social sustainability presents business opportunities for us as an industry. I used several of my favourite slides, e.g the one I have borrowed from Stina Billinger at SPP:

The Sustainable Quadrant

Read more about the Sustainable Quadrant in my blog post from Dec 2, 2010. Another one of my favourite slides is the Walderik-Mattson pyramid:

Walderik-Mattson pyramid

Read more about this pyramid in my blog post from March 29 last year (in Swedish unfortunately…).

I did also of course talk about different sustainability initiatives that the industry has taken. One of them is the environmental classification of pharmaceutical substances on Fass.se.

Environmental classification of fass.se

Read more about the classification initiative via this link.

And finally let me also mention that I presented the schematic figure that I call “4 steps to a sustainable use of pharmaceuticals”:

Read more about this schematic on my blog post from Feb 8, 2011.

Thanks to Jonny and Kristofer from Pharma Network for arranging the meeting and thanks to you participating in the discussion. I appreciated the discussions, and I actually needed the break today…