Legal Public Affairs

We develop and implement market access strategies and manage relationships with key national and regional stakeholders. We advise businesses, patient organisations, scientific societies and trade associations. Where the matter requires it, we engage our international network of leading law firms and specialist market access consultancies to provide comparative global analysis of the relevant technical issues.

We draft position papers, technical analysis and legislative proposals, and engage with the relevant parliamentary committees and institutional decision-makers. We understand the route by which a proposal becomes law — through committees, rapporteurs, opinions and amendments — and shape the client’s technical contribution at each stage.

We build structured, multi-level institutional positioning programmes across government, parliament, independent authorities and agencies, and the regions, through one-to-one meetings, participation in technical working groups and targeted institutional events. We do more than introduce clients to institutions: we establish their standing on substantive legal, regulatory and system-wide issues, contributing directly from the analysis of barriers and the development of solutions through to their practical implementation.

Structured advocacy programmes involving the relevant sector stakeholders; knowledge partnerships with media groups to develop high-quality technical and scientific content; and the formation and coordination of multi-stakeholder coalitions addressing system-wide or specific legislative and regulatory matters. Our established relationships with leading Italian universities strengthen the scientific quality of the content and coalitions we coordinate.

Monitoring of regulatory developments from the EMA, European Commission, European Parliament and Council; analysis of ongoing legislative initiatives, including HTA, orphan medicinal products, ATMPs and medical device regulations; and engagement with relevant European decision-makers solely on technical, legal and scientific grounds. Our European work is closely coordinated with activity at national level, enabling an integrated reading of both regulatory agendas.

We develop and implement market access strategies and manage relationships with key national and regional stakeholders. We advise businesses, patient organisations, scientific societies and trade associations. Where the matter requires it, we engage our international network of leading law firms and specialist market access consultancies to provide comparative global analysis of the relevant technical issues.

Regulatory advice in dealings with Italian and European authorities across medicinal products, medical devices, food supplements and cosmetics; early access programmes, marketing authorisations and market entry procedures; pricing and reimbursement and payback governance; advertising and promotion; recall, withdrawal and shortage procedures; Patient Support Programmes and engagement with patient organisations and scientific societies; and assistance in administrative and sector-specific civil proceedings. Our compliance oversight ensures that all public affairs and market access activities are conducted in accordance with the applicable regulatory framework and sector best practice.

We draft position papers, technical analysis and legislative proposals, and engage with the relevant parliamentary committees and institutional decision-makers. We understand the route by which a proposal becomes law — through committees, rapporteurs, opinions and amendments — and shape the client’s technical contribution at each stage.

We prepare political and institutional briefings that analyse the context, map decision-makers’ positions and provide short-, medium- and long-term outlooks. Our scenario analysis of specific legislative and regulatory matters is enhanced, through our international network of law firms, by comparative legal insight into how other jurisdictions address the same technical issue.

We build structured, multi-level institutional positioning programmes across government, parliament, independent authorities and agencies, and the regions, through one-to-one meetings, participation in technical working groups and targeted institutional events. We do more than introduce clients to institutions: we establish their standing on substantive legal, regulatory and system-wide issues, contributing directly from the analysis of barriers and the development of solutions through to their practical implementation.

Continuous tracking of parliamentary measures, regulatory agency decisions, government initiatives, European developments and national and European case law; tailored newsletters and thematic reports by therapeutic area and specific matter. Early warning of initiatives under development.

Structured advocacy programmes involving the relevant sector stakeholders; knowledge partnerships with media groups to develop high-quality technical and scientific content; and the formation and coordination of multi-stakeholder coalitions addressing system-wide or specific legislative and regulatory matters. Our established relationships with leading Italian universities strengthen the scientific quality of the content and coalitions we coordinate.

Conferences, institutional roundtables and technical and scientific dialogue initiatives. Each format is designed to maximise the quality of engagement and strengthen the client’s standing with relevant decision-makers, solely on technical, scientific and legal grounds.

Monitoring of regulatory developments from the EMA, European Commission, European Parliament and Council; analysis of ongoing legislative initiatives, including HTA, orphan medicinal products, ATMPs and medical device regulations; and engagement with relevant European decision-makers solely on technical, legal and scientific grounds. Our European work is closely coordinated with activity at national level, enabling an integrated reading of both regulatory agendas.