Bengt Mattson

As you are aware of from my blog posts last week (Feb 18 first post and Feb 18 second post) and the one from this Monday, there has been a lot of discussions on the Swedish Radio regarding releases from pharmaceutical manufacturing in India. Today there was a new news item on the radio news show ("the Echo" or in Swedish Ekot). I refer to this news item as "Ekot 8" in alignment with the numbering from last week. The translation has been made by the LIF office (LIF is the Swedish association of the research based pharmaceutical industry) using "Google Translate".

Ekot 8: "Stricter environmental requirements for medical manufacturing" (Radio: “The Echo”, Wed 23 Feb)

Following the revelation that the manufacture of pharmaceutical compounds causes resistance bacteria to spread in India and globally, the Swedish rules will be tightened for drugs that Swedish counties buy.

For the first time, the environmental impact of manufacturing will be inspected before the county buy drugs, "says Professor Åke Wennmalm, former Environmental Director of Stockholm County Council.

- The idea is that we should have a system that includes manufacturing variables, that is, emissions, quality and so on, and also the working conditions and other human aspects for those involved with production, "says Åke Wennmalm.

To date, the exchange system of medicines in pharmacies requires that the cheapest drug copy has to be sold. The system annually saves seven billion SEK for the state of Sweden. To the cost of a deteriorating environment around the Indian factories that account for nearly half of the production of drug compounds sold in Sweden. A sufficiently effective treatment of wastewater will result in higher prices for the products.

Since an increasing number of alarms comes from India - both of very high levels of antibiotics in wastewater from manufacturing, and of unexplained illnesses suffered by the residents around the plants - currently more and more voices are being raised for an environmental classification of medicines.

There is already a voluntary Swedish system where medicines environmental impact is reviewed. Manufacturers are asked what emissions their products cause. So far it only contains emissions to wastewater after use, but now starts also the examination of how manufacturing affects the environment, "says Åke Wennmalm.

- I think we can have a sort of protocol for how that review will function, maybe this year. Then, it must be applied, so after a few years I think we will begin to see results from it.

When can I, as a patient, get medication manufactured in an environmentally friendly manner?

- At the best, you can get it within a year, because there are certainly drugs that already meet these requirements that we are considering for new drugs. Many drugs, however, obviously will not reach them, or most of them will not, "says Åke Wennmalm, professor of clinical physiology and former Environment Director, Stockholm County Council.
When Åke Wennmalm talks about potential alterations in the enviromental classification scheme of pharmaceutical substances on fass.se, he refers to a meeting with the "environmental classification working group" that was held in late January at the LIF-office. Read my summarizing minutes of the meeting at the following link (the discussion about the classification scheme is presented in the last part of the blog post).

We did all agree that it is worth looking into expanding the classification scheme to also include other criteria, such as manufacturing conditions for instance. But how it will evolve no one can know for sure. Let me quote my own words from the January 28 blog post:

"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."

I hope to see a fairly rapid development here, but as long as there are no real incentives presented, I have personally hard to believe that changes will come... If the government and/or the County Councils only look for the lowest possible price, the changes are not likely to come and to be spread all over the industry...

Bengt Mattson