#EAPM looks to the rentrée with hope and resolution for public health

Hello, one and all – the European Alliance for Personalised Medicine (EAPM) hopes that you are safe and healthy. August, the traditional time of les grandes vacances, is just around the corner and, while this year may prove to be more the year of the ‘staycation’, with quarantines and lockdowns still very much in place in certain European locations, EAPM is nevertheless having its final discussions with MEPs and other power-brokers in the health industry, and our newsletter will be arriving shortly this week. The exodus from Brussels and Europe’s other capitals will begin very soon, and hope springs eternal in normal years that certain problems will have solved themselves by the time of the rentrée. Unfortunately, coronavirus is not a traditional self-eliminating political problem. Oh well, on with the news: writes EAPM Executive Director Denis Horgan.

Orphan medicine, personalised medicine: Cousins, not identical twins

With the Commission review of the orphan and pediatric drug regulations due this month, there is some discussion on the overlap between personalised medicine and orphran treatements.  Orphan drugs are created and designed to treat rare diseases. This is an example of population stratification in the sense of medicines, and of course it can be called ‘personalised’.

However, with the growth of personalised medicine it is necessary to make a distinction between personalised healthcare in the broader context, and the specifics of orphan drugs. They are not the same. Orphan drugs are merely one aspect of the personalised medicine framework.

Why orphan drugs and personalised medicine need to be treated differently:

• The umbrella terms of ‘personalised medicine’ and ‘personalised healthcare’ are covered, not by just one regulation or protocol, but are affected by for instance regulations on data sharing and privacy, IVDs, clinical trials, cross-border healthcare and more 

• They are also affected by AI, research, education of healthcare professionals, interoperability, patient input, doctor-patient co-decision making and, again, more

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• Medicines and treatments form just one part of the sphere of personalised medicine/healthcare. For example, one cancer patient may respond to a mixture of chemotherapy and radiotherapy, another may respond only to chemo, while a third may respond only to radiotherapy. Similarly, some cancers may respond to immunotherapy. This is clearly not a ‘one drug’ issue, it’s much more about understanding results of a particular treatment in a particular patient

• Orphan drugs treat a small amount of patients so, of course, are personalised in that way. But the medicine is merely one part of the treatment and the Orphan Regulation needs to stand distinctly because of that

•  Removing the special incentives from orphan drug production by putting such drugs under a convenient personalised healthcare banner will have very predictable results: the medicines will not be produced, the healthcare needs will not be met, and patients will die needlessly

• Orphan drugs represent a unique link in the healthcare chain and, as befits their name, should stand alone

• Orphan medicines are based on targeting small numbers of patients. Personalised medicine/healthcare involves everybody, including rare diseases sufferers. Personalised medicine can cover the concept of orphan drugs, but orphan drugs cannot cover the concept of personalised medicine - It is merely one part and unique in its own right.  

Read EAPM’s published article on orphan medicines here.

Equitable access to health in Europe 

A key driver of EU health policy is the mandate that all people should have equal access to medicines. But escalating medicine prices, particularly for new medicines, is creating a divide between European Union member states. While health-care systems in some countries are currently trying to shoulder the heavy financial burden of high-priced medicines, others—particularly those struck by recent austerity measures—are unable to bear the cost, forcing patients to go without needed treatment. As medicine prices and our pharmaceutical needs continue to increase, the pharmaceutical expenditure in all EU countries is simply unsustainable.  Action is needed, particularly during these very difficult times of coronavirus, to ensure that medicines become affordable and available for every European citizen. 

The EAPM is working to achieve this, conducting research into medicines inequities and access to testing in EU countries, and also developing and offering policymakers recommendations to  improve access and the rational allocation of resources to support the uptake of innovation. And, to create action at a national level in Eastern European countries where inequalities are often greatest, our work aims ensure that more EU citizens get the medicines they need, when they need it, at a price they can afford.

Education on the global benefits of vaccine technology

As we all know, vaccination has reduced the burden of infectious diseases. Paradoxically, a vociferous antivaccine lobby thrives today in spite of the undeniable success of vaccination programmes against formerly fearsome diseases that are now rare in developed countries. Understandably, vaccine safety gets more public attention than vaccination effectiveness, but independent experts and the World Health Organization have shown that vaccines are far safer than therapeutic medicines. 

Eradication requires high levels of population immunity in all regions of the world over a prolonged period with adequate surveillance in place. The next disease targeted for eradication is polio, which is still a global challenge.  Both the German Council presidency and the Parliament’s European People’s Party have said they want to make asserting the bloc’s role in global health a priority. However, the EU “lacks a modern vision on global health,” argued a coalition of NGOs in a press release Friday. 

The race to acquire a vaccination against coronavirus is in full sway, but it is known there won’t be enough of the earliest coronavirus vaccines to go around. That means some tough choices about who gets them first. However, Gavi’s COVAX facility is selling itself as a way to ensure equitable distribution. 

The pharma industry points to it as the best way to ensure equality, but this has not stopped companies from negotiating exclusive deals with rich countries. As for those rich countries — especially in the EU and UK — they’ve pledged to ensure fair access, but as yet there is nothing holding them to their word. Doubtless, time will tell. Worryingly, a survey of 1,023 adults conducted by HuffPost and YouGov this past week  (23-24 July) in France, found 32% of respondents would decline a coronavirus vaccine. Obviously, there is still much work to be done...

All for more transparency on new meds reimbursement

On Friday (24 July), there was an announcement in Italy’s official gazette concerning a rehashing of the rules of engagement for how the Italian medicines agency (AIFA) negotiates with the pharmaceutical industry on reimbursement for new medicines.

So these rules have some of the elements drafted by ex-AIFA chief Luca Li Bassi, including disclosure of public funds for R&D and pricing in other countries. Transparency is a key issue in the area of meds reimbursement – EAPM hopes this is a positive pointer to the future.

And finally…

Picture the scene – the UK’s Transport Secretary Grant Shapps no doubt was setting off happy with his family to Spain on Saturday (25 July) with his family. But, just hours later, the UK government had issued new rules, saying that all travellers returning from Spain would have to self-isolate for two weeks, following a sharp spike in the infection rates in several regions of the country. As Labour’s Shadow Health Secretary Jonathan Ashworth told Sky News: “You couldn’t make it up, I think that tells you everything about the government’s approach to this.”

And that’s all for now – if you are among the fortunate souls who actually have a holiday destination to head to, stay safe, stay well, and take your time to relax. Coronavirus isn’t going to disappear any day soon but, as Winston Churchill famously once said: “For this is not the end, nor the beginning of the end, but it is, perhaps, the end of the beginning.” As mentioned, our newsletter will be issued in the next few days, so keep an eye out for this.

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