Reasonable Legal Agreements - Patient Focused Medicines Development

Reasonable agreements

Collaboration between pharmaceutical companies and patient advocates often requires both parties to sign contracts covering various topics. However, these agreements are often too long, and are difficult to understand, sometimes containing ambiguous clauses.

That’s why the multi-stakeholder project “Reasonable agreements between patient advocates and pharmaceutical companies” (an initiative lead by WECAN with the collaboration of PFMD) aims to improve legal agreements between both parties while providing adequate protection and rules for both sides.

Guiding principles presentation
Guiding principles document

As part of a strong methodology, a series of guiding principles were developed via a collaborative approach between the involved parties. This will become the baseline for the development of contracts and contract templates as well as a toolbox for patient advocates and companies.

Click on any topic below to discover the rationale, suggestive examples and the actual guiding principles.
Click here if you are curious who contributed to the development.

Confidentiality

RationaleRationale

  • Sensitive, non-public information of both contractual parties needs to be protected from disclosure to third parties.
  • This is not only about confidentiality of corporate information, but about confidential and competitive information of both contractual partners (e.g. a policy campaign, a service, a tool).

ExamplesExamples

  • Commercially sensitive information about products or services of the company, e.g. product, financial or regulatory information
  • Strategic plans or processes of either contractual party
  • Unpublished scientific data of either contractual party
  • Planned public campaigns or policy actions
  • Draft project plans or concepts of either contractual party
  • Personal data, patient data

PrinciplesGuiding principles for legal agreements

  • Provide definition of confidential information
  • Have consent on disclosure of confidential information
  • Provide justification for requesting confidentiality
  • Ensure labelling of confidentiality level of information, define status of unlabeled information
  • Agree that public information is no longer confidential
  • Ensure deletion of confidential information
  • Acknowledge that legal requirements and disclosure obligations may override confidentiality

Intellectual property

RationaleRationale

  • IP protects creations of the mind, which have both a moral and a commercial value.
  • IP gives both parties the opportunity to further develop ideas and concepts brought in and generated in such meetings, either jointly or separately, and also with competing organisations
  • IP allows to exploit the results of work in products, initiatives and services.
  • IP rules ensure information, projects and work owned by a party prior to the collaboration remains their property.
  • Most content or results of a meeting are not commercially sensitive.

ExamplesExamples

  • Consultancy work: Advice provided on company-sponsored clinical trial protocols, regulatory documents or product information about the company’s products (e.g. drugs), strategic initiatives and other commercially sensitive projects.
  • Collaborative work: Concepts and services jointly developed during the term of the agreement, e.g. reports, advice, workshop agendas, patient information materials or other documents.
  • Presentations, projects, concepts, documents developed by the patient / patient organisation or the company and then presented at the collaborative meeting.
  • Third-party material: Illustrations or slides of third parties used in a presentation in a workshop or advisory board.
  • Logos of organisations or companies.

PrinciplesGuiding principles for legal agreements

  • Applicable law may prescribe definition of IP terms
  • IP on consultancy or collaborative work on specific company products should belong to the company
  • IP resulting from collaborative work unrelated to a specific product of the company should be agreed on a case-by-case basis
  • Authorship rules apply for publications
  • Background IP remains with the owner
  • Rights of third-party material need to be clear and cannot be transferred
  • Use of logos requires written consent

Recording of meetings

RationaleRationale

Recordings of a meeting and individual participants might be made for the purpose of compiling minutes or a report of the meeting for internal or external use.

ExamplesExamples

  • Minutes, documents, quotes, photos or audio-visual recordings relating to joint meetings, as well as summary of meeting outcomes and concepts.
  • Presentations held by participants of the meeting.

PrinciplesGuiding principles for legal agreements

  • Agree about use of recordings prior to meeting: 
    • Without agreement, internal use of recordings only is a given.
    • External use of these presentations and recordings requires prior consent to protect both intellectual property and public credibility.

Data protection and use of personal data

RationaleRationale

  • Personal data of patients or patient advocates needs to be protected in order to avoid any misuse of the information
  • Protecting patients’ medical condition from becoming known in the public domain
  • Protecting the credibility of a patient advocate in the public
  • Ensuring all external data are used for limited, specifically stated purposes, and in a way that is adequate, relevant and not excessive
  • Ensures data are kept for no longer than is absolutely necessary

ExamplesExamples

  • Personal data: information related with an identifiable person (e.g. name, age, position, address, affiliation with organisations, medical condition, or other personal details)
  • Third parties data: data acquired from another source, confidential or public
  • Use in quotes, internal or external reports, websites, campaigns, social media channels, offline media

PrinciplesGuiding principles for legal agreements

  • Personal data is confidential by default.
  • Agree on good reasons for data disclosure: In case that the disclosure of personal data was required to deliver on the defined objectives, there must be a separate clause in the contract, clearly stating which data needs to be released and what the purpose of the disclosure is.
  • Allow sharing of data with affiliates and involved service providers: The contracts should allow the company to share or transfer personal data to its affiliates.
  • Respect right to withdraw consent: The owner of the data is entitled to object, access or request correction or deletion, of his or her personal data anytime.
  • Data protection rules should comply with applicable privacy laws: This relates to the collection, use, disclosure and storage of personal information
  •  Ensure data protection also in countries with lower privacy standards.

Financial compensation and reimbursement of expenses

RationaleRationale

  • Patient advocates deserve a reasonable financial compensation for their time and contribution when acting in advisory roles, consultancy, speaking roles or other collaborative work
  • Financial compensation is offered in exchange for contributing with time, ideas or other means by patient advocates
  • Financial contribution is based on a company and expertise-related “fair market value” and subject to local laws and regulations

ExamplesExamples

  • Contribution to a meeting, conference, advisory board or committee organised by the company itself or by a third party.
  • Reviewing materials, leaflets, protocols, guides, recordings, concepts, etc. and providing feedback on those.
  • Consultancy work on products or services of the company.
  • Develop materials together with pharmaceutical companies e.g. patient information.

PrinciplesGuiding principles for legal agreements

  • Compensate according to fair market value: Honorarium or financial compensation for services should be reasonable and it should represent the fair market value, taking into account individual expertise and training, total amount of time invested, complexity of tasks, country of origin, and other contributing factors, similar to compensation of other highly trained professionals or consultants. A proposal on a methodology should be discussed between patient advocates and pharmaceutical companies.
  • Reflect total time invested including physical presence and real preparatory work done to carry out the service (e.g. pre-read material, pre-meeting surveys). It may also cover part of travel time.
  • Respect the right to refuse compensation.
  • Provide choice of contractual partner wherever possible: if allowed, the patient advocate should have the choice whether the contracting party receiving the honorarium is the patient organisation or the individual. Other options such as donations to an independent third party or grants may be discussed on a case by case basis
  • Reasonable travel expenses should be covered. Travel planning, conditions and reimbursement should take into account the specific needs, physical or mental, of the patient’s condition. In case an individual patient has a justified medical need to be accompanied by other persons, travel costs of accompanying person should be paid. Long-distance flights justify higher flight class. WHO or the EU institutions’ travel policies should be taken as a reference.
  • Reasonable three-way travel costs on duty should be covered. Multi-day stopover on advocacy duty should be permitted.
  • The parties should strive to agree on settlement of a payment within 30 days after the date of the invoice. The same should apply to reimbursements of costs.

Adverse events reporting

RationaleRationale

  • Regulatory provisions require pharmaceutical companies and its employees and contractors to report adverse events through its pharmacovigilance department to regulators
  • Legal agreements from pharmaceutical companies often require consultants to notify the company in writing of any adverse event occurring relating to company’s products
  • Due to the nature of an independent advisory/speaker/ consultancy role and the organisational structure of POs, these obligations are impossible for patient advocates to fulfil

ExamplesExamples

  • “The Consultant will inform the company within twenty-four (24) hours of becoming aware of any adverse event”.
  • “The Consultant will cooperate with the company to enable the company to comply with applicable laws and regulations.”

PrinciplesGuiding principles for legal agreements

  • The company remains responsible for adverse event reporting: Should any SE/SAE be uncovered in the collaborative work, it is up to the company to follow applicable laws and regulations to report those SE/SAE to the respective bodies.
  • An agreement between pharmaceutical companies and patient advocates should not require the latter to do adverse event reporting, or it should be limited strictly to the adverse events detected within the collaborative work.

Independence and conflict of interes

RationaleRationale

  • Patient advocates promote the interest of their constituencies, usually patients and carers, and the broader patient community. 
  • Patient advocates and pharmaceutical companies may have similar interests regarding topics that can affect patients’ lives in areas such as research, treatment, care and access.
  • Interactions between patient advocates and pharmaceutical companies will be done in a way that ensures that the decision making of the patient advocate side is respected and not influenced by the pharmaceutical company.

ExamplesExamples

  • Any incentive or reward of any type that would influence a patient advocate’s decision making, opinions or statements about any drug or diagnostic tool, among others.

PrinciplesGuiding principles for legal agreements

  • Respect the independence and autonomy of the patient advocate. Specifically, any decision-making by the patient advocate should be respected and not influenced by the pharmaceutical company.
  • Safeguard the independence of patient advocates by avoiding and declaring potential conflicts of interest: collaborative work and/or remuneration shall not constitute in any way an inducement to, or reward for, recommending or taking any decisions favorable to any products or services of the company or its affiliates.
  • Avoid exclusivity clauses: In order to respect the independence of patient advocates, the pharmaceutical company should not request nor expect exclusivity from patient advocates.

Authors & participants

In order to develop these guiding principles, two workgroups were established:

The Drafting Workgroup, represented by legal experts from MPE, WECAN, PFMD and pharmaceutical companies, was consulted in developing guiding principles, helped providing examples of problematic or reasonable clauses from pre-existing contracts, and provided 15 insights on legal requirements, areas or compromise and areas of no consensus. Members were:

Ananda Plate (MPE)

Advocate, lawyer, internal/external representation of the project, co-author and reviewer

Andrea Herrmann (Takeda)

Pharmaceutical company representative

Ana Vallejo (MPE)

Advocate and project manager

Charlotte Roffiaen

Advocate and lawyer

Imma Barral (University of Barcelona)

External legal expert and reviewer

Gordon Oliver (IBTA)

Advocate, lawyer and reviewer

Gregor von Arx (Novartis)

Pharmaceutical company representative

Jan Geissler (CML Advocates Network)

Advocate, co-author and reviewer

Kathy Oliver (IBTA)

Advocate and reviewer

Nicholas Brooke (PFMD)

Multi-stakeholder input and reviewer

Šarunas Narbutas (POLA)

Advocate and lawyer, co-author and reviewer

Virginie Vassart (Merck MSD)

Pharmaceutical company representative

The Multi-Stakeholder Alignment Workgroup, composed of representatives of pharmaceutical companies involved in this project as well as patient advocates from WECAN, provided input into the drafting process and acted as reviewers in multiple review cycles throughout 2017-2018. Legal experts from the following companies were involved: AMGEN, Bayer, Bristol-Myers Squibb, Celgene, Janssen, Merck MSD, Novartis, Novo Nordisk, Pfizer, Roche, Servier, Takeda.

In addition to the aforementioned patient advocates from the drafting workgroup, the following persons were involved in the multi-stakeholder workgroup:

Guy Bouguet
(Lymphoma Coalition Europe)

Marc Boutin
(National Health Council)

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