Objetives and scope
The project aims to streamline the legal framework between the patient community and the pharmaceutical industry, providing guidance for the content of legal contracts while maintaining reasonable safeguards for both contractual parties. Project objectives included:
Development of the Guiding Principles on Reasonable Agreements between Patient Advocates and Pharmaceutical Companies. A series of Guiding Principles were developed via a collaborative approach between the involved parties. The Principles aim to serve as a baseline for the development of contracts and contract templates for patient advocate engagements with industry to ensure reasonable protection for signing parties and to provide guidance to patient advocates whenever they need to review a legal agreement. The goal of the Guiding Principles is not only to simplify the terms of typical agreements, but also to prevent the addition of unnecessary clauses for either party and to simplify the language of the agreements. Find more information here.
Development of Reference Agreements for different types of engagements that have been developed in alignment with the Guiding Principles. These have been created for the four most common types of engagements:
These Reference Agreements are intended to constitute a resource for legal parties responsible for drafting agreements with patient advocates. The Reference Agreements require tailoring by a competent legal advisor according to the needs of the users and the context of use, although flexibility has been safeguarded to ensure the templates can be used in the widest possible set of circumstances.
Adaptation on a case by case basis to comply with national legislation and language requirements is also needed. The Reference Agreements represent a sensible approach but are not a substitute for taking appropriate legal advice on the documents in question./span>
To launch the project, two workgroups were established – the Drafting Workgroup and the Multi-Stakeholder Alignment Workgroup (MSAW)./span>
The Drafting Workgroup developed the Guiding Principles by reviewing pre-existing contracts from pharmaceutical partners, highlighting problematic and reasonable clauses, as well as legal requirements and existing codes of practice./span>
The people involved in the Drafting Workgroup are:
- Imma Barral (University of Barcelona), external legal expert and reviewer
- Nicole Wicki (MPE) – Advocate and project manager
- Ana Vallejo (MPE) – Advocate and project manager
- Ananda Plate (MPE) – Advocate, lawyer, Internal/external representation and reviewer
- Gordon Oliver (IBTA) – Advocate and reviewer
- Kathy Oliver (IBTA) – Advocate and reviewer
- Jan Geissler (CML Advocates Network) – Advocate and reviewer
- Šarūnas Narbutas (POLA) – Advocate and lawyer
- Charlotte Roffiaen – Advocate and lawyer
- Nicholas Brooke (PFMD) – Multi-stakeholder input and reviewer
- Virginie Vassart (Merck MSD) – Pharmaceutical company representative
- Gregor von Arx (Novartis) – Pharmaceutical company representative
- Andrea Herrmann (Takeda) – Pharmaceutical company representative
The Multi-Stakeholder Alignment Workgroup (MSAW) is comprised of all RAPP project partners with legal expertise representing individual pharmaceutical companies, WECAN members, MPE, PFMD members, the National Health Council and external experts. Legal experts from the following companies were involved at various stages: AMGEN, Bayer, Bristol-Myers Squibb, Celgene, Janssen, Merck MSD, Novartis, Novo Nordisk, Pfizer, Roche, Servier, Takeda and in addition to PFMD industry partners.
Both workgroups provided multiple cycles of review and feedback throughout the project and ideas and advice on all documents drafted.
How can your company become involved in the multi-stakeholder alignment workgroup?