Unused Medicines and Environmental Classification

I participated in two good and productive meetings yesterday with several of the stakeholders within the pharmaceutical sector. The first meeting was on un-used medicines and the second one on the environmental classification scheme for pharmaceutical substances on Fass.se.

Discussion on un-used medicines

Discussion on un-used medicines

LIF, the association for the research-beased pharmaceutical industry in Sweden, has been collaborating for several years with relevant stakeholders, e.g. the old Swedish pharmacy monopoly Apoteket AB and Svenskt Vatten (in English: The Swedish Water and Wastewater Association), to secure that the public returns un-used medicines to pharmacies and a secure and proper disposal of those medicines. Some of the conclusions drawn over the years regarding attitudes among the public and ”technical data” has been published in ScienceDirect by Matilda Persson and others. And Matilda Persson, working at LIF, was one of the representatives on yeasterday’s meeting on un-used medicines. Additional participants to me and Matilda, as seen in the picture above, were Nina Viberg from SKL (in English: Swedish Association of Local Authorities and Regions), Staffan Castensson from Swedish MPA, Kajsa Wahlberg representing Svenskt Vatten, and Inger Näsman representing the Swedish Pharmacy Association.

We all felt the importance of initiating a campaign, with relevant follow-up, to secure continued high awareness among the public on the necessity of returning un-used medicines to a pharmacy. This is important both from a safety/security point of view and from an environmental point of view. Due to the fact that the Swedish pharmacy market has been de-regulated (i.e. no more pharmacy monopoly) we all felt a need to inform the public that no matter where medicines were bought, any un-used medicines can be returned to any pharmacy. LIF will take the leading role and drive the project with an aim of running a jointly designed campaign and attitude survey in fall 2011 and into 2012. I will definitely come back to this project as time goes by.

Discussions on environmental classification

Discussions on environmental classification

Yesterday afternoon was spent with some of the same stakeholders discussing the future of the environmental classification scheme for APIs (Active Pharmaceutical Substances) published on www.fass.se. Partcipants in this meeting was myself, Matilda Persson and Gisela Holm (eco-toxicologist from AstraZeneca) representing LIF, Åke Wennmalm representing Stockholm County Council, Nina Viberg from SKL, Staffan Castensson and Charlotte Unger from Swedish MPA, Inger Näsman representing Swedish Pharmacy Association, and Karl Lilja from IVL Swedish Environmental Research Insitute.

 The classification scheme was developed collaboratively with the stakeholders and launched by LIF on Fass.se 2005. The plan was to present environmental risk assessments and existing environmental data for all pharmaceuticals substances available on the Swedish market before end of 2010. We have met the objective, and gone through all the different so called ATC-codes. Although, as you all are aware of I guess, several data gaps exist it is possible now to draw some general conclusions regarding environmental characteristics of APIs, e.g.:

- Most of the substances are considerad to have insignificant environmental impact. Moderate risk or high risk has only been ascribed to 4% and 1% of the APIs respectively. This is very positive information.

- Roughly 80% of the assessed susbtances do not show bioaccumulative potential. Also a very positive outcome.

- The negative results are to be found regarding the stability of the substances. The majority of the assessed molecules are potentially persistent.

But as you probably understand, an environmental risk assessment of the substance itself does not tell the full story. There has for instance been a lot of discussions the last few years regarding releases of APIs from manufacturing facilities in e.g. India. For more information on the topic in detail see my blogpost from August 16, 2010. Also as a direct consequence of the discussions regarding ”green incentives” it is about time to start evaluating whether or not additional aspects and pespectives should be added to the environmental classification. For more details on ”green pharmaceuticals” and/or ”green incentives” you could read my blogpost from e.g. Nov 12, 2010. As you know, I personally and the member companies in LIF, are strongly favouring ”market driven solutions” before regulatory actions. This is due to both that we believe in general in the power of financial incentives, but also due to the fact that proposed regulatory initiatives, e.g. introduction of environmental requirements in GMP, will probably take at least 10 to 15 years before they are realized. LIF’s environmental committee and the ”LIF Sustainable Development Task Force” has developed the following 4 step process to reach a sustainable use of pharmaceuticals:

4 steps to a sustainable use of pharmaceuticals

4 steps to a sustainable use of pharmaceuticals

It might be somewhat problemativ to read the details in the figure above. But I promise that I will come back to the scheme several times here at the blog during spring since there will be a lot of discussions for instance driven by the National Pharmaceutical Strategy. But in essence the scheme says that ”green incentives” and ”green criteria” are extremely important in step 4, entitled ”Green Choices within Health Care and Society”.

And what is a ”green criteria”, based on which a products and/or a company could be branded ”green”? Of course one critical aspect is the environmental risk assessment of the substance itself, but additional aspects could be manufacturing releases and emissions, packaging solutions, transport patterns and so on. In the meeting yesterday, Åke Wennmalm talked about his ideas regarding a ”crash test” of pharmaceuticals. Read more about his ideas on via this link to Läkemedelsvärlden. Since the criteria must be possible to evaluate objectively by authorities such as Swedish MPA and TLV (in English: The Dental and Pharmaceutical Benefits Agency) in order for them to be able to present ”green incentives” to industry we of course need to find ways to present enviromental information in an ”science based, clear and concise manner”. One proposal worth to look further into was presented by Staffan Castensson at the meeting: Water footprint. Staffan participates on behalf of MPA in a working group focused on the development of an international standard in the area (i.e. ISO 14046).

We have a long way to go, but the process has been initiated. And I am proud to say that, as for the environmental classification scheme development, LIF has decided to be in a driving seat.

Stay tuned…

CSR is only sustainable if integrated in business strategies

The last few days, two of my favourite CSR and environmental newsletters on-line, ”CSR-i-praktiken” and ”Miljöaktuellt” have had two interesting articles on the topic ”CSR should build financial value and revenue” in order to be sustainable. One of the articles has been written by my good friend and my favourite CSR-guru Daniel Steinholtz, and the other one by the chairman of Stockholm Chamber of Commerce, Peje Emilsson.

I do really agree with both of them, which is probably not a big surprise to anyone of you who have followed my blog previously. Read for instance my blogpost from March last year entitled ”CSR – an integrated part of the business”.

I am happy to see that more and more people dare to stress what is actually quite obvious: It is not only OK to make a profit from your sustainability programs, it is actually a pre-requisite for those programs to be sustainable themselves!

Läkemedelsriksdagen – The National Pharmaceutical Strategy

We were roughly 130 delegates who gathered today for the ”Pharmaceutical Parliament” (in Swedish: Läkemedelsriksdagen). The event has been initiated by our four ”pharmaceutical agencies”, i.e. MPA, TLV, Socialstyrelsen, and SBU.

The topic this year was three facous areas in the National Pharmaceutical Strategy: Patient Safety, cost efficiency, and sustainable development. The opening lecture was given by the Minister for Health and Social Affairs, Göran Hägglund.

Göran Hägglund

Göran Hägglund

We had a lot of interesting discussion during the day but let me focus on sustainability, and especially on environmental matters. The thing I personally was most curious of before the seminar today, was how the discussions would continue from this past Tuesday regarding ”TLV and environmental matters”. You may remember from my blog post from Tuesday that TLV, the Swedish pricing and reimbursement authority, surprised not only me by clearly stating that they can take into account environmental matters in their decisions. This clear statement was also high-lighted in Läkemedelsvärlden yesterday as something very interesting.

And the discussions at Läkemedelsriksdagen today, really supported the TLV statement from Tuesday. And my feeling is that everyone attending the seminar today became even more convinced of the necessity of incorporating environmental discussions in the process going forward. I do not think that anyone was left unaffected by Joakim Larsson’s presentation regarding pharmaceutical substances releases in India. As you know I have discussed the issue here at the blog several times (e.g. Aug 16, 2010), but I guess for some people in the audiance today, it was new information. And not a pleasant one…

Joakim Larsson

Joakim Larsson

Joakim received a lot of positive feedback on his speech. And probably the strongest evidence is that prior to his talk, a referendum was held with mentometers in the room answering the question ”Are there any environmental impacts from pharmaceuticals?”. 94 responded YES, 25 NO, and 8 DO NOT KNOW. After Joakim’s presentation the same question was answered this way: 127 YES, 5 NO, 3 DO NOT KNOW.

I think especially Joakim’s discussions on the potentail spread of antimicrobial resistance scared several of the attendees at the conference. Joakim really paints a horrifying scenario…

As I mentioned already this Tuesday, the general understanding is that the National Pharmaceutical Strategy with the focus area Sustainable Development is a very important process to manage the problems discussed by Joakim. If you read my blog post from Jan 5, you are also aware of the MPA has received a governmental commission to proceed evaluating their proposals, especially the ”GMP-proposal”, from the report on stricter environmental standards. Industry will follow and participate in these two parallel initiatives during spring 2011. And we have a very important task to continue explaining the value of financial incentives. It ws clear from the discussions this Tuesday, and once again today, that we cannot only evaluate the ”regulatory path”, i.e. including environmental matters in GMP, but also need to explore the possibilities for ”green incentives”. I was really happy to hear Christina Åkerman’s (Director General at MPA) final comment in the concluding panel debate that MPA will not only look into the GMP-path but also for instance discuss environmental aspects connected to substitution and the generic reform. I think that is very important! Because I believe Joakim is right when he says:

- ”A pharmaceutical product that may be substitutable to another product from a strictly medical point of view, is not necessarily substitutable if environmental aspects are taken into account”.

I am very sure that I will come back to this topic several times during spring…

Pharmaceuticals and the Environment – ”Tablett till Toalett”

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, 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

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

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

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

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

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

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

Bengt Simonsson, Teknikmarknad

Counterfeit medicines, or Förfalskade läkemedel in Swedish

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.