Pharma's sustainability functions are working hard on CSRD — the Corporate Sustainability Reporting Directive. Most are doing the right things: mapping emissions, assessing supply chain risks, preparing disclosure templates. The problem is that CSRD is not primarily asking about emissions — and the part of the regulation that carries the greatest strategic weight for pharma is almost entirely absent from the preparation work.
That part is double materiality. And it puts pricing and patient access at the centre of the disclosure, not the periphery.
What double materiality actually requires
Most corporate sustainability frameworks operate on single materiality: how do external factors affect the company? CSRD imposes double materiality — which requires disclosure in both directions simultaneously. How do external sustainability factors affect enterprise value? And how do the company's own decisions affect people and the environment?
For pharma, the second direction is the one that changes everything. A company's pricing decisions affect whether patients can access a medicine. Its launch sequencing determines which countries get access and when. Its evidence strategy determines which patient populations are included and which are excluded from reimbursement. Under CSRD's impact materiality requirement, those decisions are disclosable — not as CSR narrative, but as auditable reporting against defined standards.
The relevant standard is ESRS S4 — one of the European Sustainability Reporting Standards (ESRS), the technical reporting standards that sit underneath CSRD and define what companies must actually measure and disclose. ESRS S4 covers consumers and end-users. Within S4, the "access to products and services" sub-topic requires companies to assess and disclose their material impacts on the populations who depend on their products — including geographic availability, affordability, and the equity implications of launch and pricing decisions. Pharma access is not adjacent to this standard. It is the primary application of it.
The question CSRD is asking isn't "what are you doing for sustainability?" It's "what is the measurable impact of your pricing and access decisions on the patients who depend on your medicines?"
The access data that will appear in disclosures
The access picture in Europe is already documented and will become progressively more visible. EFPIA's 2025 WAIT Indicator found that the median time from EMA approval to patient availability across Europe is 532 days — ranging from 56 days in Germany to over 1,200 days in Romania. Only 28% of centrally approved innovative medicines have full availability across European markets, down from 42% in 2019. Nearly half — 49% — are either not reimbursed or still awaiting a reimbursement decision.
of centrally approved innovative medicines approved in Europe were not available to patients in 2025 — either not reimbursed or awaiting a reimbursement decision. Up from 46% in 2019 (EFPIA WAIT Indicator 2025).
These are not contested figures. They come from the industry's own trade body. Under CSRD, they are the baseline against which a pharma company's individual access performance will be measured and disclosed. The gap between a company's internal access narrative and this external benchmark will be visible to investors, regulators, and institutional analysts in a way it has not been before.
The financial case is already documented
The instinct in many access functions is to treat CSRD as a compliance burden — something to be managed by the sustainability team, reported against, and disclosed at minimum viable standard. That instinct is commercially mistaken.
The financial case for treating access as a strategic rather than compliance disclosure is well established. Research consistently links strong ESG performance and disclosure to lower costs of capital, stronger valuations, and improved investor confidence — with studies documenting financing cost advantages of 40 to 60 basis points for ESG-integrated companies. The institutional universe applying ESG screens to investment mandates stands at $33.9 trillion in 2026 (Bloomberg Intelligence). These are the funds that will read a CSRD disclosure and ask whether a company's access performance is a risk or a credential.
This is not a CSR argument. It is a CFO and investor relations argument — and it lands in a different room.
Three signals pointing the same direction
The structural shift is already visible from three independent directions.
HTA bodies are incorporating equity dimensions into their assessments as explicit rather than discretionary criteria. NICE's January 2022 updated methods guide — its first substantive revision in over a decade — introduced a health equity impact assessment as a standard component of technology appraisals, requiring applicants to demonstrate how a medicine performs across socioeconomic and geographic subgroups, not just in the trial population. The EU Joint Clinical Assessment (JCA), mandatory for oncology products from January 2025, similarly requires relative effectiveness assessments that explicitly address population heterogeneity across EU member states. Both frameworks moved in the same direction within three years of each other. The definition of "value" that access functions have been optimising for is being structurally widened by the bodies that set the rules.
Institutional investors running ESG-screened portfolios are asking access questions that used to live exclusively in the HTA room. The question "how does your launch sequencing affect patient access in lower-income European markets?" is now a due diligence question, not an advocacy one. It arrives from the investor relations function, not the access team — and most access functions are not prepared to answer it.
Regulators are building access disclosure requirements into frameworks that used to be purely financial. CSRD is the most significant of these, but it is not isolated. The direction of travel across multiple regulatory frameworks is towards making the relationship between pricing decisions and patient outcomes visible, auditable, and consequential for enterprise value.
The access community has spent a decade fighting for a seat at the top table. CSRD just put access on the investor and regulatory disclosure agenda. That's a different kind of leverage — and most organisations haven't worked out what to do with it yet.
What this means for access strategy
The companies that are ahead of this shift are not treating access and sustainability as parallel workstreams that happen to intersect at reporting time. They are integrating them at the strategy level — before the evidence plan is finalised, before the launch sequence is set, before the pricing corridor is established.
The practical implication is specific: access strategy needs to be built with disclosure consequences in mind from Phase 2. The evidence design choices that determine which patient populations are included in an HTA submission are also the choices that determine what the access equity story looks like in a CSRD disclosure three years later. The launch sequencing logic that protects an IRP basket is also the logic that produces a 1,200-day wait for patients in Romania — and that wait will appear in an auditable report.
This is not an argument for abandoning commercial discipline in access strategy. It is an argument for building access strategy to a higher standard — one that accounts for the full range of consequences, and that positions the company credibly in front of a disclosure environment that is becoming more exacting, not less.
The organisations that treat CSRD as a sustainability reporting problem will spend considerable resource on disclosure and generate limited strategic value from it. The organisations that treat it as an access-strategy problem will build a disclosure position that reflects genuine strategic integration — and that compounds into enterprise value, cost of capital, and investor credibility over time.
I'd welcome perspectives from others navigating this intersection — whether you're working in access, sustainability, investor relations, or on the commercial side. If this maps to something you're working through, reach out directly at faisal@latifstrategic.co.uk — I'm having this conversation with a number of organisations right now and am happy to share what's emerging.
The regulation is new. The underlying question is not.