Pfizers miljö- och ansvarsblogg

Regulatory Update - Pharmaceuticals and the Environment

Kategorier:

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!

Urbanization, Growth, and Sustainable Development

Kategorier:

Stockholm Chamber of Commerce arranged a breakfast seminar today in Sollentuna (in conjunction with the Board Meeting of the local section of the Chamber of Commerce in Sollentuna/Kista) with their managing director Maria Ranka. Maria’s topic of the day was the global trend of urbanization and the importance of growth in cities to drive growth for entire countries.

Maria Ranka

Maria showed several examples on urbanization and the creation of huge cities around the globe. That trend is most likely un-stoppable, and most likely not even something that we would like to stop. There are good reasons to believe that there are positive effects both socially and environmentally with urbanization. Nevertheless, both urbanization and economic growth are very often questioned from the sustainability perspective. Maria’s message is that if we manage the trend of urbanization correctly, there is no doubt that the positive effects are greater than the negative effects. If we look on the ecological footprint per capita it is clear that cities have smaller footprint than the country-side. But we need to secure that long-term investment strategies when it comes to infrastructure, public transportation, building of residencial houses and commercial facilities etc. are developed intelligently!

I really liked the discussion, and it is crucial for the future. The trend of urbanization will not stop and hence we need to understand and manage the trend in order to utilize all the great possibilities we see. I also believe that financial growth is extremely important, and hence also needs to be done in a sustainable way (which actually is the basis for sustainable development…).

After Maria’s discussion we continued with a Board meeting with the Sollentuna/Kista section of the Chamber. I have been part of the Boeard for a few years and have realized that this work is very positive when it comes to secure sustainable development. Enterprises are part of the solution on sustainability, we are not the problem!

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

Kategorier:

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!

Pharmaceuticals and the Environment - “Tablett till Toalett”

Kategorier:

I attended a very interesting seminar on the topic Pharmaceuticals and the Environment today. It was called “Från Tablett till Toalett” (in English: From pill to the toilet). The seminar was arranged by Mistra Pharma and Svenskt Vatten (in English: The Swedish Water and Wastewater Association), and they took us on a trip under the supervision of moderator Charlotte Permell, from research and devlopment of a pill, through manufacturing, via handling by authorities, County Councils and pharmacies, to the waste water treatment plant. A summary of the presentations and discussion will be published on mistrapharma.se and svensktvatten.se in the coming days but you will find my reflections from today below.

Gisela Holm, AstraZeneca

Gisela Holm from Astra Zeneca, representing the industry trade association LIF today, gave a number of examples on initiatives within the industry aimed to reduce environmental impact from pharmaceuticals. Gisela talked about, among other things, green chemistry and the LIF-initiative to publish environmental data on fass.se. Gisela stressed the importance of “green incentives” from society to industry in order to drive the environmental agenda.

Charlotte Unger, MPA

Green incentives were also mentioned by Charlotte Unger, environmental manager at Swedish MPA, although she underlined that the main proposal MPA gave in their report on the governmental commission regarding stricter environmenmental standards was to add environmental requirements to GMP. Charlotte presented the new governmental commission they received now in Jan 2011, to elaborate more on that topic (see my blog post from Jan 5, 2011). She also mentioned that the belive that the on-going process to develop a Swedish National Pharmaceutical Strategy, where Sustainable Development is one of 5 focus areas, is a key platform for continued discussions on these issues. Read more about the Pharmaceutical Strategy on my blog post from Dec 12, 2010, and via this link.

The presentation that gave me the strongest surprise today was given by Magnus Thyberg, from TLV (in English: The Dental and Pharmaceutical Benefits Agency). Magnus clearly stressed, in contrast to what I have heard several of his colleagues say before, that TLV already today is entitled to take environmental concerns into consideration in their decisions. This may perhaps not be a surprise to you if you have not been following the discussions the last one to two years, but to me it surely was surprising…

Magnus Thyberg, TLV

This is interesting news to us all, since in order to be able to develop ideas on economic green incentives, and to implement them on the market, TLV would play a crucial role. Magnus also, like Charlotte Unger, stressed the importance of the ongoing process on the Pharmaceutical Strategy for future discussions.

Magnus received a clear support on his opinion, that TLV has the authority already today to take environmental issues into account, later in the seminar from Karin Johansson, from Ministry of Health. The Minstry of Health seems to have great expectations on the National Pharmaceutical Strategy process and discussions that follows. On a direct question from me, Karin said that in addition to regulatory development (i.e. add environmental requiremenst to GMP) one could if deemed appropriate also look into the pricing and reiumbursement system.

Karin Johansson and Charlotte Permell, moderator

We also had the privilege today to listen to Cecilia Marlow, CEO for Kronans Droghandel and chairman of the Swedish pharmacy association. Cecilia has been very clear with her opinion at several occasions before that patients and pharmacy chains should be able to “act green and responsible”. However, the pricing and reimbursement system, and especially perhaps the generic substitution regulation, prohibits that to a large extent. I recommend you all to read Cecilia’s debate article from today, “Increase the possibility for green pharamecuticals“,  where she elaborates on the topic.

Cecilia Marlow, Kronans Droghandel

I was also happy to listen to the representatives from the County Councils, Annika Christensson from Blekinge and Lars Lööf from Västmanland. They both talked about the role and responsibilities of the County Councils, but clearly stressed the importance of collaborations with all stakeholders. They gave several examples on initiatives they have taken to minimize the environmental impact, and also looked forward to to discussions around the development of the Pharmaceutical Strategy.

Annika Christensson and Lars Lööf

We also listen to presentations by Per Baummann from Svensk Dagligvaruhandel (in English roughly the “Supermarket Association”) and Anders Finnson from Svenskt Vatten.  Per discussed the new situation where supermarkets since the de-regulation of the Swedish pharmacy market are allowed to sell prescription-free pharmaceuticals, and Anders presented a study performed to see if the de-regulated pharmacy market represents a risk that un-used medicins will not be properly collected. A short conclusion would be “not really, but there is place for improvements”… We also listen to Jes la Cour Jansen from the MistraPharma-project when he described their research on improved waste water treatment methodologies. For more information see mistrapharma.se and my blog post from Oct 29, 2010. Before the panel discussion we also got the privilege to hear Gustav Andersson, politically responsible for environmental issues in Stockholm County Council, describe his views on “what has been done so far, and what more to do”. As you all know, Stockholm County Council with the former environmental director Åke Wennmalm, has been one of the pioneers on pharmaceuticals and environmental matters in Sweden. Gustav mentioned the importance to remain focused on environental issues, and especially on water related matters.

You will find Per, Anders, Jes and Gustaf with all the other presenters on the picture below. As you can see, it was a huge collection of important stakeholders gather in the panel today!

Panel discussion

Let me conclude with the following: Good discussions today, and especially interesting was the clear message that also TLV will participate actively in the forthcoming discussions. The seminar ended in a very positive spirit, a lot of ideas of new initiatives and collaborations. And we even got the possibility in the end of the panel discussions to listen to Bengt Simonsson from Teknikmarknad when he described their work with eliminating pharmaceutical residues from waste water up-stream using urine separation.

Bengt Simonsson, Teknikmarknad

Counterfeit medicines, or Förfalskade läkemedel in Swedish

Kategorier:

Yesterday’s issue of the newspaper Metro (front page and page 2) discusses the problems with counterfeit medicines (in Swedish: “Förfalskade läkemedel”) and internet pharmacies (in Swedish: “Internetapotek”). It is a huge problem and the money involved are estimated to exceed the amount from the narcotics business for criminal gangs! And it is really not surprising since the risks involved for the criminals are fairly low when dealing with counterfiet pharmaceuticals compared to e.g. narcotics.

The establishing of a large number of easily accessible internet pharmacies, very often believed to be real authorized pharmacies by the public, has increased the business very rapidly.

Is is an important part of the credibility of the pharmaceutical industry, and for pharmaceuticals as such and good value of medical treatments, that these counterfeited medicines are found and destroyed. In many cases, the best thing you could hope for is that the counterfeit medicines do not have any effect what so ever. In many cases however, they are very toxic… The could for instance consist of lead and paint. Definitely not healthy! And it will definitely not cure your diseases…

Increased awareness of the problem is crucial. And hence, articles such as the one in Metro are very welcome. But I also suggest that you take a look on the following web page: crimemedicine.com

A pretty horrifying story isn’t it? Pfizer collaborates with e.g. MPA and other authorities and police and customs around the world to fight counterfeiting. Read more via this link.