Birgit Mertens Sr. Principal Environment. Inter-Association Industry Initiative: Eco-Pharmaco-Stewardship

Transcription

1 Birgit Mertens Sr. Principal Environment Inter-Association Industry Initiative: Eco-Pharmaco-Stewardship

2 Pharmaceuticals in the Environment (PiE) 2

3 Eco-Pharmaco-Stewardship (EPS) Recognizing the need for a tailored approach to the environmental management of pharmaceuticals, the industry proposes a holistic program, based upon a life-cycle approach, aimed to address environmental concerns while leaving patient access to medicines unimpeded Key Features: Applies the widely-accepted principles of product stewardship All participants involved in the product life-cycle take shared responsibility for the control of impacts resulting from use A post-approval extension of the ERA-process where warranted, without impacting patient access to medicines Continual monitoring and re-assessment of environmental risks with changing use and market growth Initially the innovator, then others entering the market share responsibility for products containing the same API. It is envisaged that level of responsibility is commensurate to the market share 3

4 Priority EPS Activities Extension of Scientific Knowledge Base in cooperation with stakeholders Effluent emission control from manufacturing Extended Environmental Risk Assessment (eera) IMI ipie project Industry Guidance for effluent control Post-Authorisation ERA model Developing a high quality eco-database Develop effects & exposure prediction models Addressing prioritization methodology for legacy products Support early R&D Establish risk based control Give technical guidance Sharing practices Provides a framework for ongoing environmental review post launch and a mechanism to follow up on identified risks Not compromising patient access to medicines 4

5 IMI ipie project Intelligence led Assessment of Pharmaceuticals in the Environment (ipie)- A Research Programme for developing methodology to prioritize not yet assessed legacy compounds Expected Benefit A better understanding of the relative risks posed by pharmaceuticals in the environment. Tools to screen and prioritise existing products for a definitive ERA. 5

6 Why this IMI research programme? ipie is over 10Mill, 4-year research programme co-funded by the Commission and industry through the IMI programme, including many stakeholders as project partners and in an advisory body An estimated 1000 potentially environmentally relevant APIs are not adequately assessed for their environmental risks The developed prioritization methodology is expected to be an accepted tool to predict candidates with potential to have an environmental impact, thus avoiding different prioritization schemes for APIs Efforts on testing and assessment in industry and regulatory bodies can concentrate on potentially critical compounds 6

7 Risk Profiles for Human Medicinal Products As part of a wider prioritisation exercise Roo s et al. (2012), looked at the PEC:PNEC for 196 of 582 human medicinal substances on the Swedish Market ERAs employed a conservative worst case exposure scenario based on assumption that 100% of API enters the aquatic environment (e.g. human metabolism and STP removal were ignored). There was room for risk refinement Less 3% had a PEC:PNEC >1 >90% posed low or insignificant risk Vast majority of APIs registered in the EU since 2006 (EMA ERA guidelines) with full ERA dataset have PEC:PNEC < 1 7

8 How does ipie address stakeholder concerns? A large number of untested legacy pharmaceuticals can be screened for potential environmental relevance It is time and resource effective by focussing on most critical compounds It is transparent and incorporates science and regulatory interests by broad stakeholder involvement It will provide a validated methodology to prioritize legacy pharmaceutical compounds for further environmental assessments The tools can be used to flag environmental risks earlier within development and help develop a more intelligent approach to ERA with a more long-term goal to assess the feasibility of greener drug design 8

9 Industry Guidance for Effluent Control A guidance on how to assess and control the potential impact of API residues in manufacturing effluents Expected Benefit Broaden awareness, share practices and provide guidance resulting in improved performance of the management of manufacturing effluents 9

10 How does manufacturing effluent control address stakeholder concerns? Action can be taken proportionate to the risk identified Established risk assessment procedures can be used The approach is facility- and product specific Practices can be shared amongst industry and incorporated into Company policies Increases transparency Further: Practices of manufacturing effluent assessments and control is providing a useful tool to assess and improve effluent quality where necessary A benchmarking study has been performed amongst pharmaceutical companies and an Industry Effluent Management Workshop is planned for November 2015 to share best practice. 10

11 Excellence Builds on Continual Improvement 11

12 Pharmaceutical Supply Chain Initiative 12 Disclaimer: Not all EFPIA members are part of PSCI

13 PSCI Principles Ethics Business Integrity and Fair Competition Identification of Concerns Animal Welfare Privacy Labor Freely Chosen Employment Child Labors and Young Workers Non-Discrimination Fair Treatment Wages, Benefits and Working Hours Freedom of Association Health and Safety Worker Protection Process Safety Emergency Preparedness and Response Hazard Information Environment Environmental Authorizations Waste and Emissions Spills and Releases Management Systems Commitment and Accountability Legal and Customer Requirements Risk Management Documentation Training and Competency Continual Improvement 13

14 Post-Authorisation ERA model A Proposal for extended Environmental Risk Assessment throughout the Lifecycle of a Medicine eera Expected Benefit The eera concept addresses questions from scientific, environmental and economic perspectives as it takes account of all products containing the same API and calls for risk management resource deployment as and when an established risk is identified. eera will also improve the scientific rigor of the current ERA by ensuring that it reflects the latest published research findings. 14

15 Thoughts on a possible extension to the current ERA model Two key components: 1) Formal transparent process for post approval commitments Agreement that identified potential risk (e.g. PEC/PNEC>1) requires further work Details on how this might work in practice 2) Proposal for post approval ongoing environmental review Refine predicted environmental concentration with post-marketing use data Regular literature review based on risk Formal communication of findings 15

16 Schematic outline of the eera-process Present scheme: - Marketing Authorization Application (MAA) - Line Extension (variation) ERA shows potential for environmental risk (PEC/PNEC 1) Environmental risk assessment (ERA) new product ERA shows no potential for environmental risk (PEC/PNEC <1) Post approval commitment ERA Refinement Refined ERA shows potential for environmental risk New scheme Refined ERA shows acceptable environmental risk Change of risk assessment Post marketing - ongoing environmental risk review Ecosystem based approach No significant risks found ERA with additional data still shows environmental risk Risk management Involvement of all stakeholders for a transparent, shared process 16

17 eera Through the API Lifecycle 17

18 How does eera address concerns of stakeholders (e.g. as expressed in the development of EC PIE Strategy)? eera does not stop with authorization Ongoing ERA review of pharmaceuticals post-approval and launch will provide up-to-date environmental information eera provides a risk assessment based on compound Total risk from all human medicinal products containing the same active ingredient is considered (total PEC approach) Increased transparency of ERA data and potential to cross-reference Risk identification is performed during authorization process broadly accepted and reviewed, no need for independent risk identification processes under different legislations Follow-up responsibilities defined with appropriate risk mitigation measures where necessary eera reaffirms industry s commitment to robust ERA while ensuring patient access to medicines 18

19 Conclusions Eco-Pharmaco-Stewardship (EPS) is the industry-proposed approach to provide a framework of environmental stewardship for pharmaceuticals covering the life-span of a pharmaceutical product EPS provides the information required to address concerns on PiE: Outcome of ipie can be used as a basis to identify priority legacy substances for further testing and assessment Evaluation of manufacturing effluent assessments and control is providing a useful tool to assess and improve effluent quality where necessary eera will ensure environmental risks are up-to-date and address many of the stakeholder concerns raised in the BIO-IS report and EC PIE workshop in 2014 Providing knowledge and data enabling assessments of sustainability of pharmaceuticals 19

20 The Association of the European Self-Medication Industry (AESGP) is the official representation of manufacturers of non-prescription medicines, food supplements, and self-care medical devices in Europe. Contact: Miranda Moussa Regulatory and Scientific Affairs Manager Tel: +32 (0) Website: The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the research-based pharmaceutical industry operating in Europe. Contact: Sini Eskola- Director Regulatory Affairs - Tel: +32 (0) Website: The European Generic medicines Association (EGA) is the official representative body of the European generic and biosimilar pharmaceutical industry. Contact: Julie Maréchal-Jamil Director Quality and Regulatory Affairs Tel: +32 (0) Website: 20