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Your Substance Advocacy Team in Brussels
- Rud Pedersen’s Substance Advocacy team helps our clients navigate the complexities of EU regulatory ecosystems, ensuring the companies maintain and grow their EU market license portfolio.
Adam Sebesta
Associate Director, Substance Advocacy Practice Lead
Integrated Advocacy Approach
It can be complex and difficult to navigate EU substance risk assessment & management processes and successfully defend your product. But it does not have to be…
What does it take to successfully advocate for your product and achieve optimal business outcomes?
→ An integrated approach by a leading European public affairs consultancy with a dedicated substance advocacy practice.
→ Unparalleled expertise combining regulatory advocacy with communications, strategic advice, and media relations.
Our team
Case Study 1: Regulatory Advocacy
Problem
When a Client learned that the European Chemicals Agency planned to restrict intentionally added microplastics from products, it knew it had to react fast. The in vitro medical devices they produce are used to diagnose infectious diseases like COVID-19 and cannot function without microplastics. The capture and disposal of these microplastics will take at least five years to be viable technically and scalable at European level.
Action
We identified and mobilised industrial partners upstream and downstream to carry targeted messages to European policymakers.
We then rallied the leading trade association in the sector to the advocacy campaign we designed to carve out an exemption for in-vitro medical devices in the REACH restriction proposal. This was a first important pre-requisite as REACH is is not the traditional area of expertise for associations operating in the healthcare sector.Solution
As a result of this work, we secured an exemption for in-vitro medical devices from the proposal on restriction of microplastics. This exemption is now part of the latest draft of the SEAC opinion and we continue to work with this Client to ensure that the exemption now largely accepted on a political level is translated into a legal reality, i.e. that it makes its way in the draft Regulation to be prepared by the European Commission.
Problem
When a Client learned that the European Chemicals Agency planned to restrict intentionally added microplastics from products, it knew it had to react fast. The in vitro medical devices they produce are used to diagnose infectious diseases like COVID-19 and cannot function without microplastics. The capture and disposal of these microplastics will take at least five years to be viable technically and scalable at European level.
Action
We identified and mobilised industrial partners upstream and downstream to carry targeted messages to European policymakers.
We then rallied the leading trade association in the sector to the advocacy campaign we designed to carve out an exemption for in-vitro medical devices in the REACH restriction proposal. This was a first important pre-requisite as REACH is is not the traditional area of expertise for associations operating in the healthcare sector.Solution
As a result of this work, we secured an exemption for in-vitro medical devices from the proposal on restriction of microplastics. This exemption is now part of the latest draft of the SEAC opinion and we continue to work with this Client to ensure that the exemption now largely accepted on a political level is translated into a legal reality, i.e. that it makes its way in the draft Regulation to be prepared by the European Commission.
Case Study 2: Reputation Advocacy
Problem
Commission Regulation 257/2010 laid out a programme for the re-evaluation of approved food additives, including E383-384 and E450-452 various phosphate compounds.These are used by our client, a leading producer of plant-based alternatives to dairy drinks and foods. The phosphates are used to improve some properties of the product e.g., to generate foam when heated.
The fear was that a range of restrictions on their use could be introduced, including an outright ban.Action
We conducted a comprehensive analysis of the issue, comprising:
Detailed regulatory procedure analysis, involving the Agency responsible for conducting a safety assessment and the procedure from which regulation would result.
A wide-ranging stakeholder analysis, mapping all the institutional decision-makers as well as the community of stakeholders likely to have and voice an opinion.
Scenario-planning, looking at evidence pointing to the likelihood of the various restrictions being enacted.
Construction and execution of an outreach strategy comprising face-to face contacts, writing position papers, opeds and internal briefings. Solution
The Client was able to develop a comprehensive understanding of the situation and to develop a robust plan to ensure that its interests were heard.
The Client was also able to develop important alliances within like-minded influencer organisations.
A range of the key institutional stakeholders were then briefed on the issues at stake and of the advantages of adopting the Client’s position.
This ensured that they Client’s position was communicated at exactly the right time in the process.
Ultimately, the Clients reputation as a credible interlocutor was greatly improved.
Problem
Commission Regulation 257/2010 laid out a programme for the re-evaluation of approved food additives, including E383-384 and E450-452 various phosphate compounds.These are used by our client, a leading producer of plant-based alternatives to dairy drinks and foods. The phosphates are used to improve some properties of the product e.g., to generate foam when heated.
The fear was that a range of restrictions on their use could be introduced, including an outright ban.Action
We conducted a comprehensive analysis of the issue, comprising:
Detailed regulatory procedure analysis, involving the Agency responsible for conducting a safety assessment and the procedure from which regulation would result.
A wide-ranging stakeholder analysis, mapping all the institutional decision-makers as well as the community of stakeholders likely to have and voice an opinion.
Scenario-planning, looking at evidence pointing to the likelihood of the various restrictions being enacted.
Construction and execution of an outreach strategy comprising face-to face contacts, writing position papers, opeds and internal briefings. Solution
The Client was able to develop a comprehensive understanding of the situation and to develop a robust plan to ensure that its interests were heard.
The Client was also able to develop important alliances within like-minded influencer organisations.
A range of the key institutional stakeholders were then briefed on the issues at stake and of the advantages of adopting the Client’s position.
This ensured that they Client’s position was communicated at exactly the right time in the process.
Ultimately, the Clients reputation as a credible interlocutor was greatly improved.
Case Study 3: Legislative Advocacy
Problem
In the heat of the debate on plastics, essential hygiene products were included in the proposal to regulate single use plastics. At best the products would be subject to a labelling regime and awareness raising measures - at worst, there would be a quantitative reduction target or a full restriction from the European market.
Action
We closely monitored developments by co-legislators, developed position papers for each stage of the legislative process and organised targeted stakeholder meetings with MEPs, attachés and Commission. Additionally, we provided senior counsel and informed members of the association about process, challenges and next steps.
Solution
The final legislation does not include restriction measures, considers a voluntary commitment by the industry and ensures that national EPR schemes reflected association members’ interest. At the same time, despite a push from NGOs, we ensured that the needle did not move in a negative direction in terms of reputation and impact on the final Directive.
Problem
In the heat of the debate on plastics, essential hygiene products were included in the proposal to regulate single use plastics. At best the products would be subject to a labelling regime and awareness raising measures - at worst, there would be a quantitative reduction target or a full restriction from the European market.
Action
We closely monitored developments by co-legislators, developed position papers for each stage of the legislative process and organised targeted stakeholder meetings with MEPs, attachés and Commission. Additionally, we provided senior counsel and informed members of the association about process, challenges and next steps.
Solution
The final legislation does not include restriction measures, considers a voluntary commitment by the industry and ensures that national EPR schemes reflected association members’ interest. At the same time, despite a push from NGOs, we ensured that the needle did not move in a negative direction in terms of reputation and impact on the final Directive.
Other sectors and practices
Who we are
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Why was the Substance Advocacy Practice created? Click the button below to learn what motivated James, our Managing Partner, to create the new practice.
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Adam Sebesta, our Substance Advocacy Practice lead also shared his thoughts on the creation of the new practice. Click the button below to watch the video.
Get in touch with our Substance Advocacy team
Do you have a need that you would like to discuss? Drop us a line, and we will gladly talk through how we can support you.