The WHO’s Essential Medicines List: Changing the Conversation

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Brendan Shaw outlines how a new approach to the WHO’s Essential Medicines List is needed to ensure both the patients of today and of the future can access the medicines they need.

 

For pharmaceutical companies, listing on the EML can be a double-edged sword.

More than 40 years after its first release, the World Health Organization (WHO) Model List of Essential Medicines has become a flashpoint in some of the health policy debates today for governments, payers, activists and industry.

When the Essential Medicines List (EML) was first introduced in 1977 it comprised 204 medicines.

Today it covers 433.

At one level, this is a concrete demonstration of scientific progress in medicine and the investment in innovation by the pharmaceutical industry over the last 40 years.

 

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The EML provides a model list for national governments and international organisations for use in developing their own medicines lists and formularies.

Today there are medicines to treat diseases such as HIV, hepatitis C, and leukaemia that were not on the list in 1977 because they simply didn’t exist back then.

 

The Evolving Nature and Purpose of the EML

Once upon a time, when the EML consisted largely of old generic medicines, it was thought of by some as only relevant to ‘resource-constrained settings’, meaning low-income countries.

It was considered a recommended list of cheap, old medicines for poor countries that was not relevant for high- or middle-income countries.

This thinking has changed in more recent times.

In 2001 the WHO decided that a medicine should not be excluded from the EML just because it might have a high price tag.

The addition of more new patented medicines to the List since then has periodically triggered discussion on issues such as value for money, affordability, patents, biosimilars, off-label use and regulatory standards in low- and high-income countries alike.

The EML is not a definitive list of every medicine that is worthwhile. There are many important medicines that are not listed on the EML for various reasons.

What an ‘essential’ medicine even is these days is the subject of debate given the changing nature of the EML, the intended audience and the broader healthcare agenda.

But this goes to show the importance of having clarity of purpose for the EML and what sort of medicines should and should not be on it.

Access to essential medicines is sometimes seen as a human rights issue, with some invoking international declarations on human rights and health to say that patients have a right to medicines, as well as to justify aggressive action to guarantee patient access.

Various campaigners have proposed policy options for automatic access to these medicines.

Frankly, some of these measures could be a disaster for future healthcare and patient access.

For pharmaceutical companies, listing on the EML can be a double-edged sword.

For a company, having a medicine listed on the EML can open opportunities in new markets and provide a platform for companies’ access to medicines programs.

But it can also open a company and its medicines up to political campaigns and for calls for substantial price controls, restrictions and automatic compulsory licensing of its patented medicines.

We know this because in the past some have used the release of each EML to launch campaigns against the industry on such issues.

The campaigns in recent years focussing on newer hepatitis C and cancer medicines are a case in point.

 

Look to the Future

Unfortunately, this crash or crash-through approach to essential medicines is a missed opportunity to take a long-term view on how patients can get the medicines they need.

If every medicine deemed ‘essential’ is regarded as fair game for campaign slogans, threats of public acquisition and compulsory licensing, what message does that send to companies that might now be developing the next generation of essential medicines?

If companies come to the view that when they develop a breakthrough essential medicine it could be compulsorily acquired the moment it is listed on the EML, as some have proposed, what incentive do companies have to develop such important medicines?

Perhaps there is also the human right that future generations of people should have access to new medicines and vaccines that have not yet been invented.

Just as action on climate change is motivated by the rights of future generations, so too we should consider the rights of future generations to obtain the medicines being developed by the life sciences sector that could treat Alzheimer’s Disease, cancer or other diseases not even discovered yet.

This taps into a larger conversation about the role of the EML and payers using it to signal to industry what sorts of medicines they want in the future.

This is something recognised in the WHO’s own objectives which say that the EML incorporates “the need for continued development of better medicines, medicines for emerging diseases, and medicines to meet changing resistance patterns”.

Unfortunately, this issue of ensuring the development of new medicines rarely features in the criticisms that sometimes accompany the release of the EML update every few years.

 

Essential but Unavailable

Another big issue is that having a medicine listed on the EML is only the first step in a process to making it available to people around the world.

The reality in many countries is that even if companies gave away all their medicines for nothing, it still might not make a lot of difference because health system infrastructure is often so poor that patients still could not access essential medicines.

What is the point of having free drugs for breast cancer if your country has no CT scanners and no oncologists to treat the patients?

Why supply medicines at no cost to a country to cure hepatitis C if there are no clinics to dispense them, no diagnostic tests available, no functioning transport network to deliver the medicines and there is corruption in the supply chain which diverts medicines to other richer countries?

 

A Different Conversation

Perhaps a better way to take the issue forward is to try to have a sensible conversation among stakeholders about how to make medicines available when they are listed on the EML.

A conversation about how companies, funding agencies, governments, international organisations and others can work together to get such medicines to the people who need them.

The ‘people’ being both the people of today getting today’s medicines and the people of the future getting the medicines of the future.

With the next Expert Committee meeting next week and the 2019 edition of the EML to be released later this year, it is an opportunity to change the conversation.

To have a conversation about a sustainable long-term future for patient access to essential medicines instead of stakeholders issuing press releases at ten paces.

 

Brendan Shaw is principal at Shawview Consulting, a specialised consulting and advisory firm for public and private sector leaders in the areas of government-business relations, policy and strategic change, with a focus on the health and pharmaceutical sectors. He is also Adjunct Senior Lecturer in Pharmaceutical Medicine, School of Medical Sciences at the University of New South Wales. 

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