Market Access Is Not the Same as Approval

Why global trials stumble on the gap between what sponsors expect and what borders allow
Featuring Mark Woolf, Chief Operating Officer, COREX

Ask a sponsor what they need to get a product into a new country and most will talk about regulatory approval. Mark Woolf, who has spent more than twenty years moving clinical supplies across the world's most difficult borders, would gently point out that approval is only the beginning of the story.

“Market access goes well beyond obtaining regulatory approval,” Mark Woolf says. “It includes importation pathways, reimbursement systems, local representation requirements, distribution networks, pricing controls, and whether the healthcare system itself will accept the product. The hidden barriers are usually administrative or licensing issues, not scientific or regulatory ones.”

In other words, the science can be sound and the dossier approved, and a trial can still grind to a halt over something as mundane as which institution is permitted to receive a shipment.


The ground is shifting under everyone's feet

Recent tariff changes and supply chain shifts have changed what regulators look at. Mark Woolf describes a clear move toward greater scrutiny of product origin, supply chain transparency, documentation accuracy, and trade compliance. Authorities are adapting their requirements to address supply chain resilience, which makes continuous monitoring of local regulations more important than it has ever been.

The United States is the obvious example. “They are looking very closely at where a product comes from, because different tariffs apply to different countries,” he explains. The composition of a clinical trial product can attract different tariffs, and recent changes were sweeping and imposed quickly. The saving grace is that they were publicised. The risk is for the company that is not watching.


What 'hidden barriers' actually look like

The barriers Mark Woolf describes are rarely dramatic. They are structural. In much of the Middle East, Saudi Arabia, Qatar, the UAE, clinical trials are managed almost exclusively through universities. Large pharma companies typically have no regulatory office and little clinical-trial presence in these countries, so approval flows through site investigators inside specific academic institutions. Because those universities are often part of government infrastructure, the route to market access runs through them.

That shapes everything downstream. Reimbursement may take the form of discounting. There may be no tax on imported items because they fall under a healthcare programme, though duties may still apply. And there are administrative barriers that have nothing to do with the product: a university hospital may insist that documentation routes through the university first, even when the physical shipment goes directly to the clinical site. The same pattern appears in parts of Africa above the sub-Saharan level, where research institutes manage local licensing, reimbursement, and healthcare-acceptance systems.

Operating where the rules move without warning

Some countries change requirements with little notice. Mark's answer is unglamorous and effective: strong local expertise, continuous monitoring of regulatory developments, and flexibility built into the supply chain and project plan from the outset.

“Even in Europe there are changes,” he notes. “The European Commission may announce something that organisations outside the EU simply miss. The EU usually gives a year or two of notice, and yet it is always a surprise how many companies have not planned for it.” The remedy is a regulatory function, in-house or through a partner, signed up to the notification systems, running a risk register, and watching for change.

He is quick to add that the era of true overnight change has largely passed. “Fifteen years ago some markets could change import regulations or tariff rates overnight, which led to rejected documentation. You would send your documents ahead to the agent and the rules had already changed. We have moved away from that.” Today, South America's larger markets, Brazil and Argentina, are consistent in their timelines, with only minor movement in tax levels. The change tends to come from policy, like recent US tariffs, rather than from administrative chaos.

The groundwork that has to happen before anything ships

For companies entering complex or emerging markets, Mark Woolf is firm that the assessment comes first: import requirements, licensing obligations, product classification, customs regulations, documentation needs, local representation requirements, and any product-registration prerequisites. Done early, this prevents the delays that otherwise surface at the worst possible moment.

A concrete example is the WDA, the Wholesale Distribution Authorisation. If you are shipping comparator product to a warehouse, that warehouse needs a WDA, an internationally recognised licence. So part of the groundwork is confirming that the receiving depot at the other end holds the right licences before a single box moves. Add correct HS codes, customs documentation prepared the way the local agent needs it, and a local representative who can guide you through, and the picture is complete.

“It is far easier to bring in a partner who already has the network,” he says, “than to try to assemble all of this yourself for every country. That is the whole reason we are in this industry.”

The biggest gap between expectation and reality

This is where Mark Woolf becomes most animated, because it is the issue he has watched derail multi-country studies for two decades: the QP release. Sponsors plan a study that ships from the US to South America, Africa, Asia, the Middle East, and into the EU, and assume one strategy will carry across all of them. It will not.

“The EU requires QP release, with a specific set of documents and temperature monitoring captured at a depot. You cannot ship direct to clinical sites, because sites do not have QP release. It has to go to a warehouse that performs that function. And QP release can take up to three months. It is not a quick, overnight thing, and there is no way around it. People have been doing this twenty or thirty years and still do not fully understand it.”

Israel is aligned to the European process but, with the right partner, far quicker, anywhere from five to twenty-one days rather than three months, still to a depot with a QP physically present. Asia has no QP release at all, but timelines differ by country: Vietnam is not Singapore, Singapore is not Australia.

Turning inconsistency into strategy

The countries that frustrate sponsors can also be used to advantage once you understand them. Singapore offers “import for re-export”: ship product in, hold it bonded at a central depot, and pay no duties or taxes until it moves on to its country of use. Send it from Singapore to South Korea and you pay duties on entry to Korea; send it to a clinical site within Singapore and you pay only on the volume that leaves the depot. Singapore becomes a hub.

Europe allows a similar play. “We regularly ship from Ireland and the Netherlands to Georgia,” Mark Woolf says. “The products are already QP-released within the EU, and because Georgia is a non-EU state we know the timelines and can streamline the process. The longest flight is about five and a half hours, so it is low-risk transportation for temperature-sensitive product.” Hold and QP-release product in Ireland, and you can then ship to clinical sites in Spain, Italy, or Estonia without paying duties again, because there are no borders within the Union.

Africa demands the opposite instinct. With summer temperatures of 35 to 40 degrees, a local depot is usually wiser than repeated long-haul shipments. Brazil needs bulk product positioned in advance, because each import licence per bulk shipment takes three months to prepare.

“Sit down with an expert at the very beginning. Map the timelines for every region, decide where to position product, and build the strategy around that. Discounting countries later is easy; we have already done the work.”

The thread running through all of it is the same. Global ambition meets local reality at every border, and the sponsors who succeed are the ones who plan for the reality rather than assume it away.

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