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It is still hot. I am still not built for it. But honestly at this point I think the heatwave and I have reached an uneasy truce.

A couple of things from last week worth sharing before we get into the substance.

England. I am not going to jinx anything by saying too much. We know what happens when we get ahead of ourselves. All I will say is that I watched the Norway quarter final through the same fingers I used for the Mexico game and I remain cautiously, nervously, quietly hopeful. We will leave it there.

The more interesting thing from my week was a meeting I did not expect to be as compelling as it turned out to be. More on that below.

Is the Gulf an opportunity for inclusive healthcare? I went to find out.

Last week I attended a roundtable with the Bahrain Economic Development Board.

I went in curious but cautious. The Gulf is not a region that immediately comes up when people talk about health equity. The conversations in this space tend to centre on the UK, Europe, the US. The communities being left out of data representation are framed almost exclusively through the lens of Western healthcare systems.

But the more I thought about it before the meeting, and the more I heard during it, the more I think that framing is missing something significant.

The Gulf Cooperation Council (GCC) states are in the middle of a healthcare transformation. Saudi Vision 2030 has it as a core pillar. The UAE is building clinical research infrastructure at pace. Bahrain is actively positioning itself as a regional hub for life sciences and health innovation. These are not aspirational statements. There is real investment behind them, real regulatory development, and real appetite to attract the kind of partnerships that would have been unthinkable a decade ago.

The region has some of the most interesting population diversity in the world from a health research perspective. A significant proportion of the Gulf's population is made up of migrant workers from South Asia and Southeast Asia — communities that carry specific disease burdens, that have specific healthcare experiences and cultural contexts, and that are almost entirely invisible in the current global clinical evidence base.

These are not communities on the margins of the Gulf's ambition. They are central to its economy. And they are carrying health conditions for which the existing evidence base is poor, because the data looks nothing like them.

The opportunity I am exploring is whether the approach we have built in the UK, going into communities, building trust, capturing structured longitudinal lived experience data, can translate into a Gulf context. Whether the clinical development teams working in that region, and the international sponsors running global programmes that touch those populations, are ready for this conversation.

My honest assessment after the meeting: the appetite is there. The infrastructure question is interesting. And the data gap is, if anything, more acute than in the UK because fewer people have been looking at it.

I do not know yet what this becomes for Unwritten Health. But it is the right conversation to be having, and I am glad I went.

The EMA just confirmed what this newsletter has been arguing for months

Something happened this week that deserves more attention than it has received.

The European Medicines Agency announced it is examining gender representation data from clinical trials across the Clinical Trials Information System. The explicit goal: to assess whether study populations match the populations likely to use the medicine.

The European Clinical Trials Regulation already requires this. What is new is that the EMA is now actively analysing the data to see whether sponsors are delivering on it. That is a meaningful shift. From expecting compliance to measuring it.

The European Parliament's report that preceded the EMA announcement was direct about the scale of the problem. When research, clinical trials and medical data fail to reflect women's experiences, the result is poorer diagnosis, treatment, and care.

That is not a niche concern. It describes a structural failure in the evidence base that shapes treatment decisions for more than half the population.

What I want to say about this is not just that the EMA is doing the right thing. It is what the announcement reveals about the state of play.

The fact that the EMA needs to run this analysis means the data does not already show that study populations match the populations using the medicines. If it did, there would be nothing to examine. The analysis is necessary precisely because the assumption cannot be trusted. And that assumption — that trials adequately represent the people who will take the medicine — has been shaping clinical practice, prescribing decisions, and patient outcomes for decades.

Women are the most visible example. But the same logic applies to every population that has been systematically underrepresented in the evidence base. Minority ethnic communities. Older patients. People with multiple comorbidities. People from lower socioeconomic backgrounds. The EMA's move on gender is the beginning of a reckoning that the data infrastructure of clinical research has been making inevitable for years.

The question for sponsors reading this is not whether this scrutiny is coming. It is whether your evidence base will hold up when it arrives.

Source: BioXconomy. EMA to analyze women's representation in clinical trials. July 6, 2026. bioxconomy.com

The IDP explainer is live

Last week I said the free plain-English IDP explainer was going live shortly. It is live now.

It breaks down what an Inclusion and Diversity Plan actually requires, the four questions every credible IDP needs to answer, and where the gaps typically are in what sponsors can currently evidence. No jargon. Written for the people who actually have to produce these documents.

Free to download. No friction.

Three toolkits. One blind spot closed.

A clinical development lead told me last week that the European Patient Evidence Navigator closed a regulatory blind spot he did not fully know he had. When you are working across multiple countries on a global programme, the local market access and HTA environment is not always visible from the centre. That invisibility is expensive when it catches you at submission stage.

The navigator covers six European markets in depth, Germany, France, Italy, Spain, the Netherlands, and the UK, with the changes that matter right now. Country by country. In a format you can use, not just reference.

Three toolkits available individually or as a bundle. Instant download.

Thanks for reading. This newsletter exists because I believe the right framing, in the right hands, changes decisions. If it did that for you this week, even a little, that is enough.

Ashish.

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