Contact

  • | Estetrol

Mithra participates to the pharmaceuticals environmental challenges conference held at the European Parliament, Brussels

  • Panel discussion between European institutions, Academia and Industry on current and future challenges to improve the management of pharmaceuticals residues in the environment and limit Industry footprint on wildlife and ecosystems
  • High need to improve the overall monitoring of pharmaceuticals in Europe and to increase support for the development of environmentally friendly medicines such as Mithra’s core asset Estetrol (E4)
  • Revision of the EU pharmaceuticals legislation ongoing with a regulation for all Member States anticipated by the end of 2023

Liege, Belgium, 8 November 2022 – 17:45 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today took part in the panel discussion “The direct effects of pharmaceuticals on wildlife, knowledge and policy gaps & solutions to support research and innovation to achieve the Zero Pollution Ambition” held at the European Parliament in Brussels. The minutes and conclusions of this conference will be available on the company’s website in the upcoming days.

Emerging concern

With over 100,000 tons of pharmaceutical products consumed globally every year (24% in Europe) and despite current wastewater filtration systems, pharmaceutical residues are found in the environment, in particular in water and soil, with a negative impact on wildlife, such as fish, birds, frogs and insects, and knock-on effects on wider ecosystems. Various recent studies have shown that some pharmaceuticals such as antibiotics, painkillers or cancer treatments, even at very low concentrations, have direct effects on wildlife. For example, fish exposed to low concentrations of certain antidepressants have been found to change their behaviour in ways that could affect their survival. Oral contraceptives based on natural or synthetic estrogens cause feminisation of fish and amphibians, and residues of psychiatric drugs alter fish behaviour.

As described in the last OCDE report on this emerging concern, unless adequate measures are taken to manage the risks, pharmaceutical residues will increasingly be released into the environment as ageing populations, advances in healthcare, and intensification of meat and fish production spur the demand for pharmaceuticals worldwide.

Strengthening of global data and support to accelerate the development of sustainable medicines

It is not feasible, neither technically nor financially, to entirely treat the sewage waters. The main challenge for a better management of the pharmaceutical residues is therefore to work upstream and strengthen the monitoring of pharmaceuticals, bring together existing data sets and develop research to fill the key data gaps in this field. e.g. on the cocktail effects of pharmaceuticals.

In addition to this data consolidation, experts also stressed the importance of supporting R&D projects for environmentally sustainable medicines, for example by providing specific funding for academia / industrial research or through incentivization like rewarding a medicine showing a favorable environmental profile with an accelerated registration process conducted by the European Medicines Agency (EMA).or with a differentiated pricing and reimbursement scheme.

“Considering the urgency of the environmental challenge for society, an attractive incentivization scheme needs to be envisaged by EU and national policy makers to support and accelerate the route to market for innovative medicines offering greater societal and patient environmental sustainability, starting from the development stages all the way to market access and pricing”, explained Jean-Manuel Fontaine, Chief Commercial and External Affairs Officer at Mithra. “We are currently developing a portfolio of innovative products based on E4, a novel kind of estrogen which displays a significantly more environmentally-friendly profile compared to alternatives currently on the market. We are working with Academia to further characterize, beyond agency requests, the environmental profile of E4. Policies that provide incentives in terms of funding to strengthen the collaboration with Academia and generate the missing data is critical”.

Prof. Patrick Kestemont, President of Research Institute of Life, Earth & Environment at the University of Namur (Belgium), commented:” At the moment the monitoring is only done by the academia and we still need a lot of information and research to be able to develop new techniques and to assess environmental impact of each compound, as well as the mixture (cocktail effects) of different compounds. There is a need for a public regulation and the EU needs to encourage the Member States to adopt ad hoc legislations to support pharmaceutical companies which are developing environmentally friendly drugs.”

New EU pharmaceuticals legislation for 2023

In 2019, the European Commission defined a series of actions to address the issue of pharmaceuticals in the environment and has set out a European Green Deal to tackle environmental-related challenges. In 2020, the Commission integrated the issue in the larger “Pharmaceutical Strategy for Europe”.

As Hans Stielstra, Deputy Head of Unit Sustainable Freshwater Management in the European Commission explained, two relevant proposals – one for a revision of the List of groundwater and surface water pollutants and one for a revision of the urban wastewater treatment Directive – were published recently. On top of this, in a few months, the Commission will publish a proposal for the revision of the general pharmaceuticals legislation which aims to improve the current legislation in terms of environmental risk assessment provisions. The text will then be discussed in the European Parliament and the Council for a publication as regulation for all Member States by the end of 2023.

In the European Parliament, MEP Cristian Silviu Bușoi, who was co-rapporteur of the Resolution on a strategic approach to pharmaceuticals in the environment in 2020, announced he will “stand for strong measures to reduce the discharge of pharmaceuticals in the environment and reducing waste”. In the same vein, MEP Sirpa Pietikäinen called on the Commission to “look at the cost of non-action, because quite often we see that when you need to do something new, it’s going to cost money for the industry and the consumers, but then if you don’t do anything, the price you pay is 10 times the initial investment”.

Download press release

PDF version

Share it

Latest news

View all

Don't miss our news

Get the latest news: subscribe to our newsletter!

Subscribe
Go to Newsroom
Contact

Disclaimer

Please read this carefully as it applies to all persons who visit this website. The following pages contain information relating to an offering and/or admission to trading on a regulated market in relation to securities of Mithra Pharmaceuticals SA ("Mithra Pharmaceuticals"). This information may not be accessed by residents of certain countries based on applicable securities law regulations. Accordingly, if you wish to access this part of the website you must first inform yourself about and then observe the statutory and regulatory requirements applicable to you and to your jurisdiction. In order to establish whether or not you may view the information and documents please read the disclaimer below in full.

THIS WEBSITE AND THE MATERIALS CONTAINED THEREIN ARE NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN, SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE TO DO SO WOULD BE PROHIBITED BY APPLICABLE LAW.

This website and the information contained herein or to which it gives access are not intended for, and may not be accessed by, or distributed or disseminated to, persons resident or physically present in the United States of America (including its territories, the "United States"), Australia, Japan or South Africa, and do not constitute, or form part of, an offer or invitation to sell or issue, or a solicitation of an offer or invitation to purchase or subscribe for, nor shall there be any sale or purchase of, any securities of Mithra Pharmaceuticals in the United States, Australia, Japan or South Africa or in any other jurisdiction in which such offer, invitation, solicitation, sale, issue, purchase or subscription would be unlawful prior to registration, unless an exemption from registration or qualification under the securities laws of any such jurisdiction is applicable. The securities of Mithra Pharmaceuticals referred to on this website have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), and may not be offered or sold in the United States absent registration with the United States Securities and Exchange Commission or an exemption from registration under the U.S. Securities Act. There will be no public offering of Mithra Pharmaceuticals' securities in the United States.

All persons residing outside of the United States, Australia, Canada, Japan and South Africa who wish to access the documents contained on this website should first ensure that they are not subject to local laws or regulations that prohibit or restrict their right to access this website, or require registration or approval for any acquisition of securities by them. Mithra Pharmaceuticals assumes no responsibility if there is a violation of applicable law and regulations by any person.

No action has been taken by Mithra Pharmaceuticals that would permit an offer of Mithra's securities or the possession or distribution of the materials to which this website gives access or any other offering or publicity material relating to Mithra's securities in any jurisdiction where action for that purpose is required.

Mithra Pharmaceuticals has not authorised any public offering in any Member State of the European Economic Area. With respect to any Member State of the European Economic Area that has implemented Regulation 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC, as amended from time to time (together with any applicable implementing measures in such Member State, the "Prospectus Regulation"), this website and the information contained herein, or to which it gives access, is only addressed to, and is only directed at, qualified investors in that Member State within the meaning of the Prospectus Regulation.

In addition, in the United Kingdom, this website and the information contained herein, or to which it gives access, is addressed to, and directed only at: (a) persons who have professional experience in matters relating to investments falling within article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order"), and (b) high net worth entities, and other persons to whom they may otherwise lawfully be communicated, falling within article 49(2) of the Order (all such persons together being referred to as "Relevant Persons"). In the United Kingdom, any investment or investment activity to which this website and the information contained herein, or to which it gives access, relates, is available only to Relevant Persons and will be engaged in only with Relevant Persons. Any person in the United Kingdom who is not a Relevant Person should not act or rely on this website and the information contained herein, or to which it gives access.

If you are not permitted to view materials on this website or are in any doubt as to whether you are permitted to view these materials, please exit this webpage. Access to electronic versions of these materials is being made available on this webpage by Mithra Pharmaceuticals in good faith and for information purposes only.

By checking the acceptance box below, you confirm and certify that: You are not a resident of or physically present in the United States, Australia, Canada, Japan or South Africa or any other restricted jurisdiction, and that you are either: (a) a resident of, and domiciled in, a Member State of the European Economic Area and a qualified investor within the meaning of the Prospectus Regulation, (b) a resident of, and domiciled in, the United Kingdom, a qualified investor within the meaning of the Prospectus Regulation and a Relevant Person, or (c) otherwise authorised to access this information pursuant to applicable laws or regulations.

Abort