Setting up an MLR process across the UK and 5 EU markets

Background

The client — a global biopharmaceutical company — had substantially increased its UK and EU market presence following a portfolio acquisition that brought additional medicinal products into its commercial footprint. That step-change in commercial activity accelerated the need for a robust Medical Legal Review (MLR) process.

The Medical Legal Review process is the structured, cross-functional review of every piece of promotional material, scientific-exchange content and HCP-facing communication a pharmaceutical company puts into market. Material is reviewed by Medical, Legal and Compliance reviewers (and, depending on the company's set-up, Regulatory) before it is approved for use — checking that each piece is medically accurate, scientifically substantiated, legally sound and aligned with the EFPIA Code of Practice and the relevant local-Country industry code (ABPI in the UK, plus the equivalent codes in France, Germany, Italy and Spain). When the process is working, it catches the issues at the desk; when it is not, those issues surface as code complaints, regulator queries and reputational risk.

The brief was deliberately execution-focused. The client did not need theoretical advisory work; they needed a team of legal and compliance professionals with industry experience inside the UK and EU markets in scope — people who knew the EFPIA Code and the local Country codes in practice, and who could roll out the MLR process, draft Country-specific SOPs, deliver training, monitor adherence and bring business stakeholders along on the journey. One above-Country EU lead to keep the rollout aligned and streamlined; six in-Country leads, each with the language capability and qualification to operate inside their market.

The LS Law Approach

Three connected workstreams: above-Country lead, in-Country execution, programme deliverables. We deployed a senior secondee team under a master consultancy agreement, with individual statements of work for each Country covering principal consultant, fee rate, time line and scope. The arrangement was deliberately flexible — ramping up or down as the rollout unfolded across the markets — and account-managed end-to-end so the client had a single LS Law contact accountable for the outcome.

EU above-Country lead. A senior compliance specialist providing the cross-market alignment layer — ensuring the MLR rollout stayed streamlined across the markets, with a coherent operating model rather than five different versions of the same process. The EU lead also acted as the secondee team liaison, holding the in-Country leads together and feeding back to the client through the account manager.

In-Country execution leads. Six in-Country secondees — UK, France, Germany, Italy and Spain — each a senior legal or compliance lawyer qualified in (or with demonstrated industry experience of) their market, with native or working language capability and direct experience of the local Country code. The roles were execution-focused: rolling out the MLR process,

drafting Country-specific SOPs that took global processes and applied appropriate local nuance, delivering training, and monitoring HCP-interaction adherence.

Programme deliverables and stakeholder buy-in. The rollout was scoped around five linked deliverables that a client's in-house compliance team needs in order to actually run an MLR process post go-live — not just on day one, but every quarter afterwards: tailored MLR process per Country; Country-specific SOPs covering promotional material approval, HCP engagement, transfers of value, advertising and digital content; stakeholder training delivered to medical, legal, regulatory and commercial teams; embedded monitoring across HCP interactions and adherence to the new internal processes; and active engagement with commercial and medical stakeholders so the MLR process was adopted as part of how the business worked rather than imposed on top of it. Each Country's deliverables fed back through the EU lead to the account manager — so if the rollout in one market surfaced an issue that affected others, the learning travelled rather than being trapped in-Country.

The Outcome

An EFPIA- and local-code-aligned MLR process rolled out across the UK and five EU markets, with above-Country alignment, in-Country execution by senior pharma-industry secondees, accompanying SOPs, training and monitoring, and the stakeholder buy-in that determines whether the process is actually used.

The operating model was account-managed, secondee-based and ramp-flexible: a single LS Law point of contact (General Counsel) managed the client relationship; we recommended which secondees would best support each Country; the master consultancy agreement plus per-Country statements of work allowed the engagement to flex with the rollout; and regular check-ins kept the secondee team aligned with client expectations.

From an accelerated post-acquisition compliance gap to a working, locally-aligned MLR process across six markets.