I have written several blog posts during the last year on the topic of environmental considerations and the pricing and reimbursement system (see for instance the blog posts from March 28, May 11, May 17, and Sept 1). I have also given my comments on the proposal from Swedish MPA to include environmental requirements in GMP (Good Manufacturing Practice). To read more on the proposal itself, and my concerns (e.g. extremely timeconsuming process) see these blog posts (Dec 16, 2009 and June 16, 2011).
Yesterday on SvD’s Brännpunkt, TLV’s (the Dental and Pharmaceutical Benefits Agency) Director General Gunilla Hulth-Backlund and her colleagues Magnus Thyberg and Martin Forsberg, discussed the generic reform in general and slightly touched upon the issues of potential environmental impacts from pharmaceuticals:
”Apoteksbranschen menar också att utbytesmodellen leder till att vi får läkemedel som tillverkats utan miljöhänsyn. Stämmer det?
TLV vill gärna bidra till att vi får mer miljövänliga läkemedel, men kan inte se att vi skulle få det just genom att införa ett annat utbytessystem. För miljöns skull är det bäst att lösa miljöfrågan på EU-nivå, när läkemedel godkänns för försäljning. Det är också Läkemedelsverkets förslag som man nyligen lämnat till regeringen.”
Based on this quote it looks like TLV would prefer regulatory changes on the EU-level rather than changes of the national pharmaceutical system, such as the mandatory change at the pharmacy desk to the cheepest generic. I cannot really tell whether the regulatory changes they refer to include the GMP-proposal or actually the incorporation of the ERA (Environental Risk Assessment) in the risk/benefit assessment when decisions on market authorizations are made. Nevertheless, I still believe changes in the national system is the right thing do to, and it is to show leadership in this field to take actions also in areas where Sweden can make their own decisions, i.e. allow for environmental considerations also within the framework of the reimbursement system. To only work for changes on the EU-level is not to take full responsibility – in the worst case, nothing would ever happen to be honest. As I have said previosuly – it is a very timeconsuming process.
I am looking forward to the upcoming discussions with TLV and other stakeholders regarding the reimbursement system and environmental aspects. Next meeting will take place on September 28, when stakeholders including TLV meet at LIF (the Swedish Association of the Research Based Pharmaceutical Industry) for next meeting in the ”round-table sessions” (first meeting was held March 28).