Hémistiches.Unisson
FR

UnissonInteractions with healthcare professionals: framework and integrity, by Hémistiches

Are your collaborations with healthcare stakeholders properly framed?

Experts, scientific committees, congresses, donations and partnerships: each collaboration must be qualified, formalised and documented under French rules. Take the test: it starts from your practices and projects, then points you to the right package, with its starting price and assumptions.

Take the test See the fees

About four minutesFreeImmediate result, no email requiredPrices excluding VAT

The name

In unison, each voice keeps its own timbre, and all play the same note.

Laboratories, healthcare professionals, hospitals, learned societies and patient associations each have their own role, and each remains independent. What they share is one score: the laws and regulations that govern their interactions.

Within the company, the same rule applies to every team: medical affairs, marketing, events, legal. And in the paperwork, agreements, payments and disclosures must all tell the same story.

What Unisson covers

Two separate French regimes govern these interactions. The first, known as the "anti-gift" rules, prohibits benefits offered to healthcare professionals, save for exceptions subject to declaration or authorisation. The second, known as "transparency", makes agreements, remuneration and benefits public. One operation may fall under both, or only one: everything starts with qualifying it.

  • Experts and servicesAdvice, expertise, speaking engagements: a genuine need, and remuneration proportionate to the service rendered (art. L. 1453-7 of the French Public Health Code).
  • Scientific committeesAdvisory boards and expert groups: selecting participants, agreements, justifying the amounts.
  • Congresses and hospitalityHospitality of a reasonable level, limited to the purpose of the event and to the professionals concerned.
  • Donations, grants, partnershipsHospitals, learned societies, patient associations: these recipients are not all subject to the same rules.
  • Benefits frameworkThe prohibition in principle and its exceptions, with their formalities (art. L. 1453-3 and L. 1453-7).
  • Transparency of interestsPublication of agreements, remuneration and benefits on a single public website (art. L. 1453-1).
  • Approval workflowWho qualifies, who approves, who tracks the formalities and their deadlines.
  • TraceabilityBeing able to reconstruct each collaboration: agreement, approval, proof of performance, disclosures.
  • Integrity around these interactionsGifts and hospitality to other contacts, intermediaries, conflicts of interest, whistleblowing procedure.

Are your collaborations in unison?

Questions on your practices and projects, accessible to a managing director as well as an operational manager. The path adapts to your answers and never asks for a name, a contract or case details.

How we work together

Three distinct needs, each with its own price

None is a mandatory step. An operation can be secured on its own; ongoing support can start directly on an organisation that already holds.

  1. Case by case

    Secure a collaboration or an operation

    From€500 excl. VAT for a collaboration, €1,000 excl. VAT for an operation

    Qualification, the agreement, justification of the amounts, and the list of formalities and documents to keep.

    The details
  2. Once

    Build the base

    From€1,500 excl. VAT for a diagnostic, €3,000 excl. VAT for the essential base, diagnostic included

    Tools your teams use on their own: qualification sheet, agreement templates, tracking table and, where needed, approval workflow and training.

    The details
  3. Every month, if you wish

    Ongoing support

    From€490 excl. VAT per month for three hours

    Qualifying operations, reviewing agreements, tracking formalities, as your projects unfold.

    The details

Fees

All prices exclude VAT. Each fixed fee rests on a scope agreed in writing: one French entity, a French scope, a defined number of documents, meetings and versions, and the adaptation of proven templates rather than fully bespoke drafting. A matter outside these assumptions is quoted before any work begins.

To begin

Orientation consultation

€350 excl. VAT

Forty-five minutes to frame a question and know where to start.

  • Reading of your test result, if any
  • Forty-five-minute video call
  • Written summary by email

Not included: document analysis and detailed opinions.

The details

Optional: no engagement requires it. Where it directly prepares a fixed-fee engagement started within thirty days, its €350 excl. VAT is deducted, once. A document analysis or a detailed opinion is a separate engagement, quoted in advance.

Diagnostic

€1,500 excl. VAT

Find out what your practices are worth and what to fix first.

  • Two interviews
  • Review of up to ten documents: agreements, procedures, disclosures
  • Gap map and prioritised action plan
  • Debrief

Not included: the corrections, an in-depth audit of each related need.

The details

The price assumes one entity, a French scope, an available contact person and documents provided in a usable format. The diagnostic also flags related needs (gifts to other contacts, intermediaries, conflicts of interest, whistleblowing) without being an in-depth audit of each.

If the base follows, the diagnostic is credited against its overall price: only the balance is invoiced. If you already have a recent, usable diagnostic, it is reviewed first and the price of the base adjusted accordingly.

Build the base

The base: essential

From

€3,000 excl. VAT in total, diagnostic included

For a lean organisation: the tools that let your teams qualify, formalise and retrieve each collaboration, with your current resources.

  • Diagnostic
  • Operation qualification sheet, to be completed before each collaboration
  • Two agreement templates adapted to your practice
  • Ready-to-use tracking table: fields needed for disclosures, calendar of deadlines

Not included: approval procedure, training, roll-out, review of past files.

The details

The price assumes one entity, collaborations of one or two types, an available contact person. Included: one round of consolidated comments and a debrief meeting. After a diagnostic already paid, only the balance of €1,500 excl. VAT is invoiced.

Not included: roll-out across the whole organisation, review of past files and completion of formalities.

The base: in-depth

From

€4,800 excl. VAT in total, diagnostic included

For more numerous or more varied collaborations, and several teams involved.

  • Everything in the essential base
  • Three agreement templates
  • Approval procedure and responsibility matrix
  • Ninety-minute training for the people who organise operations

Not included: roll-out across the whole organisation, additional training, review of past files.

The details

The price assumes one entity and a French scope. Included: one round of consolidated comments and two meetings. After a diagnostic already paid, only the balance of €3,300 excl. VAT is invoiced.

Not included: roll-out across the whole organisation, additional training, review of past files. Several entities or countries: quoted.

Complete your compliance base

The same interactions also expose the company in other ways: a gift to a hospital buyer, an agency inviting on your behalf, an expert linked to the hospital he advises, a report nobody knows how to receive. This is often where the risk concentrates. Each of these components can be ordered on its own, at its own price, with or without the base.

Gifts and hospitality policy

€600 excl. VAT

Your teams offer gifts, meals or invitations to contacts who are not healthcare professionals: hospital buyers, public officials, partners.

  • A written policy: principles, permitted and excluded cases
  • Internal value and frequency thresholds
  • An approval and recording workflow
  • A quick-reference sheet for teams

Not included: rules specific to healthcare professionals, covered by the main packages; team training; roll-out.

The details

The price assumes one entity, adaptation of a firm template to your practices and one round of consolidated comments.

Quoted: several entities or countries, a group policy to adapt, review of past practices.

Intermediaries and partners

€1,000 excl. VAT

You work through agencies, event organisers or consultants in your interactions with healthcare stakeholders.

  • The categories of intermediaries you use, and their risk level
  • A proportionate assessment procedure: questionnaire, analysis grid, approval workflow
  • Standard clauses: compliance with the benefits rules, transmission of the information needed for disclosures, audit, termination

Not included: checks on each third party, review of current contracts.

The details

The price assumes one entity, up to three categories of intermediaries, one round of consolidated comments.

Quoted: checks on named third parties, review of a partner portfolio, setting up a screening tool.

Conflicts of interest

€750 excl. VAT

Employees or regular experts have ties with the professionals or hospitals you work with.

  • The sensitive situations in your interactions with healthcare stakeholders
  • A declaration template proportionate to each role
  • An analysis procedure: a tie of interest is not, in itself, a conflict
  • Standard measures and a register: independent approval, withdrawal from a decision, framing of the relationship

Not included: analysis of individual situations, covered by ongoing support or a consultation; conflicts unrelated to these interactions.

The details

The price assumes one entity, adaptation of a firm template, one round of consolidated comments.

Quoted: a conflict-of-interest policy covering the whole company.

Whistleblowing procedure

€1,200 excl. VAT

Mandatory in France from fifty employees (art. 8 of Law no. 2016-1691 of 9 December 2016), useful below that.

  • A procedure for receiving and handling reports: channels, recipient, acknowledgement, feedback, closure
  • Responsibilities, and prevention of conflicts of interest in handling
  • An information notice for staff

Not included: consultation of employee representative bodies, which you conduct and I can prepare; operating the procedure; internal investigations; the reporting tool. The data protection side is handled by Diapason.

The details

The price assumes one entity, adaptation of a firm template, one round of consolidated comments.

Quoted: a procedure shared across a group, report intake entrusted to a third party, handling a report, an internal investigation.

Sample review

€950 excl. VAT

Your organisation is in place: you want to check that it holds up on paper.

  • Ten collaboration files selected with you
  • For each: qualification, agreement, justification of amounts, formalities, disclosure, records kept
  • Findings per file, summary and remediation plan

Not included: remediating the files, an exhaustive audit.

The details

The price assumes complete files provided in a usable format, and one debrief.

Quoted: a larger sample, several entities, recurring reviews, which Cadence can also carry over time.

A collaboration, an operation

A collaboration

€500 excl. VAT

You engage a healthcare professional or an expert for a specific assignment.

  • The relationship qualified and any formality identified, with its deadline
  • The agreement adapted to the assignment
  • The remuneration justified against the work requested

Not included: completing the formality, negotiation.

The details

Included: one participant, one assignment, one agreement, on the firm's template or by review of your draft; one round of comments; the list of documents to keep.

Not included: completing the formality and negotiating with the participant. Beyond a few collaborations per quarter, the monthly support is more economical.

An operation

From

€1,000 excl. VAT

You organise a scientific committee, congress invitations, a series of talks, a donation or a partnership.

  • The operation qualified as a whole, with its formalities and deadlines
  • An agreement adapted to each category of participants
  • Remuneration and expenses justified, with the documents to keep

Not included: the formalities themselves, logistics, individual negotiation.

The details

Included: one operation, one agreement template per type of participant, one round of consolidated comments and one meeting.

Not included: completing the formalities, logistics and individual negotiation. Quoted: several countries, several linked operations, an operation already under way to be regularised.

Ongoing support

Limited support

Three hours per month

€490 excl. VAT per month

For a few operations per quarter and teams already able to qualify them.

Regular support

Six hours per month

€990 excl. VAT per month

For monthly collaborations and teams that need support.

Enhanced support

From ten hours per month

€1,490 excl. VAT per month

Entry-level price

For sustained activity: many experts, congresses, several teams.

  • The same work at all three levelsQualifying operations, reviewing and adapting agreements, justifying amounts, tracking formalities and their deadlines, answering the teams' questions. Only volume and pace change.
  • Simple trackingA monthly time statement and an alert before the volume runs out. Unused hours are not carried over.
  • Overruns€180 excl. VAT per hour, after an estimate and your prior agreement; a substantial project is quoted as a separate fixed fee.
  • TermNo minimum term, one month's notice on either side. No standby or guaranteed immediate availability.

Other compliance needs. Anti-corruption programme, operating a whistleblowing procedure and internal investigations, review of a partner portfolio, in-depth or recurring reviews: quoted. To carry them over time, together with the rest of your legal life, Cadence provides the outsourced legal department. The anti-corruption programme required by the French Sapin II law applies to companies and groups with at least five hundred employees and turnover above €100 million (art. 17 of the Law of 9 December 2016); below that, it remains voluntary.

What Unisson does not include. Advertising of health products, marketing authorisations, pharmacovigilance, market access, product regulation, the full framework of clinical trials, competition law and international sanctions. For research, Unisson covers the relationship with investigators and its benefits; the agreement with the hospital and the rest of the trial framework are quoted separately, and data protection for the study falls under Diapason.

Prices excluding VAT. VAT at 20% is added for clients established in France; for a business client established in another Member State, it is self-assessed by the client. If we agree, the engagement is set out in a signed fee agreement before any work begins, which defines the scope, its exclusions and how the price is determined. It is preceded by a conflict-of-interest check.

And for the rest? Unisson covers interactions with healthcare stakeholders; Cadence the outsourced legal department; Diapason data protection, including the professionals' data published for transparency; Concordance medical device compliance. It is the same lawyer: work already done for you in one is reused, never invoiced twice.

Frequently asked questions

Do I have to start with a diagnostic?

No. A collaboration or an operation can be secured on its own, and ongoing support can start directly if your practices already hold. The diagnostic is for when you do not know what your practices are worth; if it leads to the base, it is credited against it.

Do we need software?

No. Software helps record and disclose; it does not tell you what must be disclosed, on what basis, or under which agreement. I work with the tool or spreadsheets you already use, and the base provides a ready-to-use tracking table.

Our group already has procedures. What is left to do?

Checking them against French rules. Procedures designed for several countries rarely address the formalities specific to France. The diagnostic compares them with your local practices and says what needs adapting.

Unisson or Cadence?

Unisson is a targeted engagement: securing your collaborations and leaving you tools your teams use on their own. Cadence provides your legal function over time, compliance included. Setting things up falls under Unisson; day-to-day operation can fit within the Cadence volume.

Is clinical research covered?

For the relationship with investigators and the related benefits. The agreement with the hospital, the protocol, filings with the authorities and the rest of the trial framework are quoted separately; data protection for the study falls under Diapason.

Are medical device companies concerned?

Yes. These rules apply to companies that manufacture or market health products, medical devices included. Unisson is aimed first at pharmaceutical companies, but applies to any healthcare company. Device-specific regulation falls under Concordance.

Does the test result commit me?

No. It is an indicative orientation, based on your answers alone: neither legal advice, nor a contractual offer, nor a compliance certification. Scope and price are confirmed in a conversation, then in a fee agreement.

Portrait of François Césure

Who sets the note

"Before becoming a lawyer, I was general counsel and compliance officer in the healthcare industry. I framed these interactions from the inside: I know what they require day to day, and what holds up when they have to be justified."
François Césure
  • LawyerParis Bar, since 2012
  • General counsel and compliance officerhealthcare industry

The framework

What is set before any engagement

  • The test is not legal adviceThe result is an indicative orientation, based on your answers alone. It does not qualify any operation and certifies no compliance.
  • An obligation of meansNo result is guaranteed: neither the removal of risk, nor the decision of an authority or professional order. The commitment covers a scope, a method and timelines agreed in writing.
  • A price per engagement, confirmed in writingEach engagement has its price, scope and assumptions, written down before starting. No additional work without your agreement.
  • Conflict-of-interest checkBefore any engagement. If there is one, you are told, and the matter is not opened.
  • Your answers stay with youThe test runs in your browser. Nothing is sent to me unless you ask to be contacted.