Open Letter Exchange with The European Medicines Agency on the Climate Emergency

 

1. About this document

The following open letter exchange with the European Medicines Agency (EMA) is provided to stimulate a democratic discussion about the role of European Agencies, especially the European Medicines Agency (EMA), in responding to the climate emergency.

The following communication is a modified copy of the communication between Wilmar Igl and the European Medicines Agency, which is based on a request for information via the public EMA website [1]. Personal, sensitive or legal information, which was considered not relevant and whose omission is not expected to bias the content, was removed (cf XXX, YYY, or ZZZ or [omitted] tags). In addition, the sequence of messages is presented in a chronic order starting with the first message to increase readability. Minor changes of formatting were applied to increase readability, again without being expected to bias the content.

Since the original message by the EMA stated:

“This message and any attachment contain information which may be confidential or otherwise protected from disclosure. It is intended for the addressee(s) only and should not be relied upon as legal advice unless it is otherwise stated.”,

consent for publication by the EMA was obtained prior to public release.

All views stated are personal (WI) and should not be used to construct views by current or past employers.

Uppsala, 2020-01-28                                                    Wilmar Igl, PhD

References
[1] https://www.ema.europa.eu/en/about-us/contact/send-question-european-medicines-agency

Postscriptum, 2020-01-31:
To understand the following discussion two concepts are important:

  • remit: The area that a person or group of people in authority has responsibility for or control over [1].
  • product feature: A typical quality or an important part of a product [2]. Here, the production process of an object is considered an essential feature of the product.

For example, if identical products are manufactured by child labour below minimum wage or alternatively by adult labour above minimum wage, to ignore the production process means, that capitalist forces promote child labour, which is not in the interest of (a fair) society.  The same applies to an arbitrary separation of medical product properties in terms of efficacy and safety (cf European Medicines Agency) and sustainable production (cf European Environment Agency), where the European Environment Agency does not seem to act upon regulation of the emission of toxic greenhouse gases during the production of medical products. The current legal situation forces the European Medicines Agency to approve medical products only based on efficacy and safety, while ignoring product properties resulting from production. While in a conventional situation, the regulatory system may be adjusted to adequately regulate the production process over time, in the current situation (eg “dramatic climate emergency”) it seems unethical to ignore available knowledge which will put members of society, in fact, large parts of the biosphere, in harm’s way.

References:
[1] https://dictionary.cambridge.org/dictionary/english/remit
[2] https://dictionary.cambridge.org/dictionary/english/feature

2. Message 1a

We received your question(s) on: 19/Nov/19

Subject of your enquiry: Reduction of toxic greenhouse gases in pharmaceutical industry

Your question(s):

Dear Sirs and Madams,

[omitted]

I recently have come across a paper by Belkhir et al. (2019) [1,2] which states that more greenhouse gases are emitted by the pharma industry than by the automotive industry, and the pharma industry has to reduce greenhouse gases by 59% until 2025 (in comparison to 2015 levels) to meet the targets of the Paris Climate Agreement.

I have now searched the EMA website for any information about limiting toxic greenhouse gases, but was not able to find a single document. In the current situation which UN secretary Antonio Guterres describes as a “dramatic climate emergency” it seems to me an utter failure of a regulator not make this a priority. Please note that we have to bend the emissions curve now (in 2020), otherwise the window to limit global warming to 2 degrees Celsius will close.

I wonder whether you can help me understand the policy and actions the EMA is taking regarding the climate emergency (also ecological emergency) and, if such a policy does not exist, bring this topic to the attention of decision makers?

Best regards,

Wilmar Igl

(PhD, MSc Med Stats, Psych)

Refs:
[1] https://www.sciencedirect.com/science/article/pii/S0959652618336084?via%3Dihub
[2] https://theconversation.com/big-pharma-emits-more-greenhouse-gases-than-the-automotive-industry-115285

3. Message 1b

Från: noreply@ema.europa.eu <noreply@ema.europa.eu>
Skickat: den 9 december 2019 18:15
Till: Igl Wilmar <YYY.YYY@YYY.YY>
Ämne: [EMA Service Desk] Re: EMA request reference ASK-ZZZZZ

Dear Dr Igl,

Thank you for your message.

Information on the carbon footprint of the pharmaceutical industry is not available on the EMA website because this is outside the remit of the Agency.

The EMA is responsible for implementing pharmaceutical legislation, including GMP guidance, which ensures quality of medicinal products during manufacturing.

Pharmaceutical legislation does not address the risk that manufacturing of APIs may pose to the environment, for instance via emission of greenhouse gases or discharge of pharmaceutical effluents in urban wastewater treatment plants. Such issues fall under environmental legislation, e.g. water legislation, carbon emission legislation, industrial emissions legislation, chemicals legislation.

Pharmaceutical legislation, however, requires that an environmental risk assessment is performed for all applications for marketing authorisation, but this assessment is based solely on the use (not production or distribution) of the medicine and the physico-chemical, ecotoxicological, and fate properties of its active substance. For more information on ERA, we encourage you to contact the MPA representatives involved in the CHMP Safety Working Party (XXX XXX, ERA guideline Drafting Group).

Although issues related to climate and environment fall outside the EMA’s remit, the Agency has contributed via inputs of its scientific committees and GMP/GDP Inspectors Working Group to the development of the communication on a European Union Strategic Approach to Pharmaceuticals in the Environment (COM(2019)128)  which was adopted by the European Commission on 11 March 2019. This strategy was required by Article 8c of the Priority Substances Directive (2008/105/EC as amended by Directive 2013/39/EU) which mandates the European Commission to propose a strategic approach to the pollution of water by pharmaceutical substances.

The Communication sets out six areas for action of water pollution: increase awareness and promote prudent use of pharmaceuticals; support the development of pharmaceuticals intrinsically less harmful for the environment and promote greener manufacturing; improve environmental risk assessment and its review; reduce wastage and improve the management of waste; expand environmental monitoring and fill other knowledge gaps. Several actions are proposed for each area of action and are to be implemented by the Commission, Member States, the relevant EU agencies and other relevant stakeholders in the coming years. The EMA is leading many actions under this strategy, particularly in the area of improving environmental risk assessment and its review, and it is contributing to efforts of the Commission and the EU Member States in the area of reducing wastage and improving the management of waste.

The importance of the issue of environmental impact of pharmaceuticals was also recently stressed in the Council conclusions on chemicals (26/06/2019) adopted by European ministers for environment protection.

It is not possible for the EMA website to provide information on actions which are outside the remit of its activities. However, further information on the above-mentioned EU strategy on pharmaceuticals in the environment and other EU policies to protect the environment can be found in the European Commission website below:

https://ec.europa.eu/environment/water/water-dangersub/index.htm#strategic

We hope this is helpful background information.

Please let us know if you have any further questions.

 

Kind regards

XXX XXX

[omitted]
European Medicines Agency
Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands
Tel. +31 (0)88 XXX XXXX | XXX.XXX@ema.europa.eu
European Medicines Agency
Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands

Got a question? Ask EMA at www.ema.europa.eu/contact

4. Message 2a

From: Igl Wilmar <YYY.YYY@YYY.YY>
Sent: 11 December 2019 11:53
To: XXX XXX <XXX.XXX@ema.europa.eu>
Subject: Reply: [EMA Service Desk] Re: EMA request reference ASK-ZZZZZ

Dear Mr XXX,

Thank you very much for your message describing EMAs remit and initiatives regarding environmental protection, esp. regarding climate action!

Unfortunately, in my personal opinion the EMA dramatically fails to take responsibility to control the emissions of toxic greenhouse gases related to drugs and medical devices:

  1. Inside the remit of the EMA, ie controlling the consumption of drugs:
    1. Propellants in inhalers [1], eg the use of an inhaler emits upto 0.4 ton CO2e/(person*year), similar to switching from a hybrid to a gasoline car
    2. Anaesthetic gases [2], eg  their carbon footprint is equivalent to 50% of gas emissions from the heating of acute NHS buildings and water

Therefore, the EMA should take responsibility to refuse or withdraw market authorisation, limit the use, or at least inform clinicians and patients about the climate-impact of the products they are prescribing or using.

  1. Outside the remit of the EMA, ie controlling the development, production, and distribution of drugs and medical devices:
    1. The separation of development, production, and distribution vs consumption of products regarding their environmental impact is artificial and harmful since it does not account for the complexity and connectedness of the problems. In your example about multiple drug resistant bacteria and antibiotics, the leakage of antibiotics into water during production, thereby creating MDR bacteria, directly affects the effectiveness of antibiotics during consumption by patients. Developing of new antibiotics while not addressing water pollution does not make sense. Similarly, developing, producing and distributing drugs in a fossil-fuel based way, which has a direct negative impact on human health, to promote human health does not make sense either [3,4]. Therefore, the above “separation” strategy will compromise the trust of regulatory assessors, scientists, and the public in the competence and integrity of the EMA and the EU.
    2. The current “dramatic climate emergency” (UN General Secretary, A. Guterres, 2019, G7 meeting) with, for example, current uncontrollable wildfires close to metropolitan areas in Australia leading to hazardous air quality, requires an emergency mobilisation and proactive action of all parties of interest beyond their remit, as long as it does not have a negative impact on the effectivity of climate action as a whole. As emphasized in the speech by Patricia Espinosa (Executive Secretary of UN Climate Change, COP25, 2019-12-10) “The window of opportunity is closing now.” [5] (ie in 2020)  to avoid catastrophic climate breakdown in the future.

Therefore, I would like to ask you in your function as a [omitted] but also as a responsible human being to urgently raise this issue with your superiors and drive forward climate action in cooperation with other EU agencies, but also national competent authorities of drug and environmental regulation.

Kind regards,

Wilmar Igl, PhD

References:
[1] Janson C, Henderson R, Löfdahl M, et al (2019). Carbon footprint impact of the choice of inhalers for asthma and COPD. Thorax, doi: 10.1136/thoraxjnl-2019-213744, https://thorax.bmj.com/content/thoraxjnl/early/2019/11/07/thoraxjnl-2019-213744.full.pdf
[2] Michael Charlesworth, Frank Swinton (2017). Anaesthetic gases, climate change, and sustainable practice. The Lancet Planetary Health. 1 (6), Pages e216-e217, https://doi.org/10.1016/S2542-5196(17)30040-2.
[3] Solomon, C. G., & LaRocque, R. C. (2019). Climate Change — A Health Emergency. New England Journal of Medicine, 380(3), 209–211. https://doi.org/10.1056/NEJMp1817067
[4] Haines, A., & Ebi, K. (2019). The Imperative for Climate Action to Protect Health. New England Journal of Medicine, 380(3), 263–273. https://doi.org/10.1056/NEJMra1807873
[5] https://twitter.com/PEspinosaC/status/1204336005546987520

[Signature omitted]

5. Message 2b

Från: XXX XXX <XXX.XXX@ema.europa.eu>

Skickat: den 18 december 2019 14:55

Till: Igl Wilmar <YYY.YYY@YYY.YY>

Ämne: RE: Reply: [EMA Service Desk] Re: EMA request reference ASK-ZZZZZ

Dear Dr Wilmar,

Thank you for raising these very important issues and for expressing your personal views on them.

I have made relevant EMA colleagues aware of these concerns.

Hopefully with the Green New Deal and the new impetus at the EU level to achieve climate neutrality there will be opportunities in the coming months to address these aspects more concretely.

Kind regards

XXX

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