Remissen från EU kommissionen gällande en strategi för läkemedel i miljön

Nu är det bara en vecka kvar innan remissen (”public consultation”) gällande en strategi för läkemedel i miljön (”the PiE Strategy” - Pharmaceuticals in the Enviroinment) stänger. Jag har skrivit om denna remiss tidigare här på bloggen. Dels den 23 november då remissen publicerades ( , dels den 22 januari då vi i den europeiska läkemedelsindustrin lämnade våra svar på den mer omfattande expertversionen (”the targeted consultation”) av remissen

Nedan beskriver jag förslag till svar på flera av de öppna frågorn i remissen, samt de olika ”kryssfrågor” (en bedömning mellan 1 och 5 av hur högt prioriterat man anser tolv föreslagna åtgärder vara). Förslagen till svar baseras på de diskussioner jag och kollegor från de europeiska läkemedelsindustriföreningarna har haft med olika intressenter (därav är texten på engelska), men är här på bloggen justerade något för att passa in i en svensk kontext och för att öka läsbarheten för allmänheten.

Det blir ett mycket långt blogginlägg men jag vill ta tillfället i akt att inte bara ge förslag på hur frågorna kan besvaras, utan även inkludera förklarande texter för er läsare. Därav inläggets längd…

Här är en direktlänk till remissen:

Frågorna 1-12 i remissen handlar om vem du är, vilken kunskap du har om läkmedel i miljön generellt och om du redan har vidtagit åtgärder för att minska eventuell miljöpåverkan från läkemedel.

13. Do you see a connection between this issue and the development of antimicrobial resistance (AMR)? (Resistance means, for example, that existing antibiotics may no longer be effective against disease-causing bacteria.)

Recommended answer: YES (alternatively NOT SURE)

Comment: Although the environmental dimension (i.e. manufacturing discharges mainly) of AMR needs further research to understand its potential contribution to AMR, recommendation would be to acknowledge the link between AMR and environment and be consistent with the AMR Roadmap – AMR Industry Alliance commitments. An alternative “Don’t know” would probably be as justifiable, since further research is needed to confirm the link between the AMR and environment.

14. What (other) aspect of the issue (of pharmaceuticals in the environment) concerns you most?

Proposal for wording: We/I support development of PIE Strategy while safeguarding access to effective treatments. Discussions on PIE often presume that PIE represents a significant risk. However, research & intensive debate show that environmental concerns are related to a few active substances & envir. risk refinement/mitigation measures should be in the focus. Risk-based prioritisation for any relevant actions should be ensured and should be based on research.

15. How do you see the need for actions (including research) to address the risk from pharmaceuticals in the environment? 

Recommended answer: URGENT

CommentEveryone should show willingness to contribute

If you wish to, please explain your answer (this is a follow-up question where you could use up to 1500 characters to explain your response)

Some ideas on wordingWe/I encourage an urgent, open and constructive dialogue on PIE with relevant stakeholders, taking into account both environmental and public health aspects. We/I believe effective PIE strategy should support research to monitor concentrations and establish PNECs (Predicted Non-Effective Concentration) for APIs based on reliable science. If risks are identified and verified, risk management should be employed in a targeted and prioritized way. As my/our scientific understanding improves, we/I will find new ways of detecting the trace amounts of pharmaceuticals in the environment and understand better their impact. Industry is striving to improve our processes and develop new ways of creating treatments that not only save lives, but that are also mindful of the environment. We/I remain committed to continuing to address environmental concerns through multiple initiatives whilst responding to patient needs and ensuring access to medicines, the paramount objective of the healthcare sector. Stewardship approach should cover actions in the full lifecycle of the medicines; research and development, manufacturing, usage and medicines correct disposal.

16. Please give each of the twelve possible actions below a score between 5 and 0, where 5 = high priority action, 3 = medium priority action, 1 = low priority action, 0 = not in favour.

1. More research to better understand the risks

Recommended answer: 5

Comment: More research is needed to understand the potential risks, and hence evaluate if and which measures that should be undertaken

2. ”Greener” design of pharmaceuticals, e.g. to make them more biodegradable

Recommended answer: 1

Comment: Fostering research into the feasibility of greener products is fine in principle; however experience to date confirms this is extremely challenging. A realistic goal is to develop better tools so that the toxicity can be predicted earlier in the development process. This is one key objective of the IMI iPiE project. In the future the proportion of biologics, vaccines and personalized medicines will increase which by default impact less the environment

3. More stringent conditions for putting a pharmaceutical on the market

Recommended answer: 0

Comment: Medicines development is a demanding process where ca. 1:10000 molecules finally reach the market. It is possible to take actions to protect the environment without implementing more stringent conditions for putting a pharmaceutical on the market, hence option “0” is justified. More stringent condition would jeopardize patient access to medicines, the paramount objective of the healthcare sector. The Environmental Risk Assessment (ERA) that are part of the registration dossier of all new pharmaceuticals should not be part of the ”medical benefit / medical risk assessment”

4. Cleaner manufacturing

Recommended answer: 3

Comment: Manufacturers should take actions where relevant, comply with current legislation and strive for best practices in manufacturing effluent management. Hot spot management/actions where problems have been identified, for example with third party manufacturer, should be considered as needed. We/I oppose environmental aspects to be part of EU Good Manufacturing Practices (GMP) for the complications and impact it would create in global supply chain (inspections) and trade agreements. If anyone would like to send an extra clear signal to the EU Commission that environmental aspects should not be part of GMP, it could be considerad to rate the proposal lower than 3 (e.g. 1 or 2).

5. Better risk mitigation, e.g. not allowing over-the-counter sale of pharmaceuticals that pose an environmental risk

Recommended answer: 1

Comment: Industry supports better risk management of APIs but the option of reversing OTC status is a disproportionate response and we oppose to it. The option fails to recognize the benefits that OTC brings to patients in terms of easier access to medicine and lowering the burden on over-worked healthcare systems and costs.

6. Better/more thorough post-market monitoring of pharmaceuticals in the environment and feedback to the regulatory process

Recommended answer: 5

Comment: Better post-authorisation management of pharmaceuticals and their environmental risks is suppoirted. By extending the scope of ERA (Environmental Risk Assessment), as proposed in industry’s extended ERA (eERA) scheme under Eco-Pharmaco-Stewardship (EPS) will allow putting efforts and resources to manage the environmental risks of APIs that show the risk (PEC:PNEC ratio > 1). For more information on eERA and/or EPS see this webinar: 

7. (a) Better training for medical professionals, e.g. about pharmaceuticals that are less harmful for the environment

Recommended answer: 4

Comment: Increased education on environmental aspects of pharmaceuticals is supported, e.g. a good example of already taken actions is the launch of medicines disposal campaign #Medsdisposal. It’s necessary that education/training programs provide clear, simple, factual, science-based information, delivered in a well-balanced way to avoid potential of any negative impact on patient adherence to their medication (e.g. making them scared to take the medicines due to environmental risks).

7. (b) Better information for the public, e.g. about how to dispose of unused medicines

Recommended answer: 3-5: Very dependent upon which member state you come from. Some countries (such as in Sweden: ”bring back any left-overs to the pharmacy”) have had regular information campaigns to the general public on recommended waste handling of unused/expired pharmaceuticals for decades.

Comment: Incorrect disposal of expired and usused medicines contribute to ca. 10% of APIs found globally in the environment (much less so in Sweden, having a well-established and implemented collection scheme). It’s important to take urgent actions to educate the citizens about the correct disposal in those countries where the system is not well known and/or not well implemented, but also regularly re-enforce the importance of correct disposal across the union to secure effectivness of already existing national collection schemes.

7. (c) Smaller packaging sizes, to reduce unnecessary waste/disposal

Recommended answer: 1

Comment: The pack sizes are part of the assessment process of the EMA (European Medicines Agency) and national competent authorities based on the indication and duration of treatment. The effort in reducing AMR (Anti-Microbial Resistance) always emphasizes the importance of not ending up with any left-overs of antimicrobials, which is supported by optimized pack sizes. However, in general to ensure the products remain available on the market, optimizing/individualizing pack-sizes for each treatment may not be feasible from a cost and/or practical point of view. At least if done so, this will directly impact the productions costs and the prices.

8. Improved handling of waste pharmaceuticals

Recommended answer: 3-5: Very dependent upon which member state you come from.

Comment: All Member States should comply with the existing directives on collection schemes for un-used/expired pharmaceuticals. They should be better re-enforced to ensure the effective implementation of the existing programs. Changing these programs would not increase their efficiency, which is directly related to patient behavior.

9. (a) Improved sewage and wastewater treatment

Recommended answer: 4

Comment: Most of the APIs found in the environment (ca. 90%) are due to the medicines use; they excrete in urine. Medical residues are only part of the broad spectrum of substances that are present in municipal wastewater in low or very low concentrations, commonly related to as “micropollutants”. Advanced waste water treatments could potentially reduce the concentrations, and improvements in technology could in the long term reduce pharmaceuticals entry into the environment. This will however require substantial financial resources and any actions in this regard should be supported by a sound benefit/risk analyses before being implemented.

9. (b) Improvements in livestock farming to reduce the use/emission of pharmaceuticals

Recommended answer: 1-5: Very dependent upon which member state you come from. Livestock farming operations/regulations may differ from country to country.

Comment: Improvements in livestock farming should be undertaken if/where relevant to secure appropriate and sustainable use of medicines.

If you wish to, please explain your scoring or add brief comments on the listed actions, referring to their number (this is a follow-up question where you could use up to 1500 characters to explain your responses)

Some ideas on wording (based upon the comments written above in conjunction to each question):

Numbers 1 and 2: More research is needed to understand potential risks and evaluate if/which measures should be undertaken. Instead of developing greener medicines, focus should be in developing better tools to predict toxicity earlier in development. In future biologics and vaccines will increase in numbers with less impact on environment

Number 3: API development is a demanding and lengthy.We/I oppose ERA as part of benefit/risk assessment

Number 4: Manufacturers should take actions where relevant, comply with current legislation and strive for best practices in manufacturing effluent management. We/I oppose environmental aspects as part of EU GMP for the complications it would have on global supply chain (inspections) and trade agreements

Number 5: Risk-mitigation option not to allow OTC sale of pharmaceutical is poor, as it lacks the recognition on why legal status of OTC has been granted: to allow easier access to treatments and ease burden on overall healthcare systems and costs.

Number 6: We/I support better post-authorisation management of environmental risks of APIs. An extended scope of ERA, as proposed by industry under Eco-Pharmaco-Stewardship will allow putting efforts and resources to manage the environmental risks of APIs that show the risk (PEC:PNEC ratio > 1).

Number 7: The pack sizes are part of the assessment process of the EMA. To ensure the products remain available on the market, optimizing/individualizing pack-sizes for each treatment may not be feasible from a cost/practical point of view.

Number 8: All Member States should comply with the existing legislation that should be better re-enforced to ensure the effective implementation.

17. If you are aware of any actions already being taken in your own country, please mention them and provide details (you could use up to 1500 characters)

Some ideas on wording: LIF (The Swedish Association of the Research-based Industry) have run regular campaigns on correct disposal for decades. LIF also took the initiative in 2005 to publicly publish (on environmental classifications of pharmaceutical substances. LIF is also leading the task to develop an environmental assessment model for pharnmaceutiucal products as part of the Swedish National Pharmaceutical Strategy. A model that could be utilized to secure environmental considerations in the generic substitution system (as proposed in a Swedish governmental inquiry in 2013). In addition to these industry initiated initiatives, Swedish County Councils have used environmental criteria in the public procurement of pharmaceuticals for more than ten years. Swedish academic researchers have been very active in the field of pharmaceuticals in the environment, for instance in the MistraPharma-project between 2008-2015 (

18. Please feel free to suggest further actions, in addition to those included in this questionnaire and the background document, or in your answer to Q.17, to address the impacts of pharmaceuticals in the environment (you could use up to 1500 characters)

Some ideas on wording: We/I support the Commission to fill knowledge gaps, explore how to protect environment and safeguarding patient access to pharmaceutical treatments. These are aligned with industry’s Eco-Pharmaco-Stewardship (EPS) program that takes a life-cycle approach to management of PiE. EPS addresses roles and responsibilities of all parties involved; industry, physicians, pharmacists, patients& public services. It presents valuable alternatives that should be considered vs. measures that might jeopardize patient access to medicines or require extensive legislative amendments when most pharmaceuticals pose low or insignificant risk to the environment

Har ni nu läst så här långt så hoppas jag att ni besvarar remissen ( och därigenom bidrar till att kommissionens strategi gällande läkemedel i miljön blir så bra som möjligt.




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