Highly priced medicines represent a significant public health challenge. Global health advocate Ella Weggen shares how Wemos is responding through its dedicated project Medicines That Matter.
According to recent independent reviews, as many as 85-90% of new medicines provide little to no clinical advantage to patients.1 The result is enormous amounts of – often public – money being invested into delivering highly priced medicines of limited added therapeutic value (ATV), while the medicines that are truly needed are left out of development plans.
Confronting this challenge is Wemos, a Netherlands-based organisation committed to improving transparency around medicines pricing, promoting independent clinical research, and lobbying for medicines that meet unmet medical needs.
Health Europa spoke to global health advocate Ella Weggen to find out more about Wemos’ work.
What does Wemos believe is insufficient about the way new medicines are currently delivered onto the market?
We at Wemos believe that health is a human right and that access to adequate healthcare and to medicines is a part of that. We believe that the government has a responsibility to make sure that people get the medicines they need. But at present it appears that the government – certainly in the Netherlands but also in countries across the EU – doesn’t have control over the pricing of certain medicines, which means that a lot of new medicines are extremely costly. In particular, the prices of certain expensive medicines, for example for rare diseases or cancer, are rising and are taking up an increasingly larger part of the health budget. Not only does this risk making our health system unaffordable, it also means that the medicines aren’t getting to the people who need them.
A big part of the problem is that we are too dependent on private companies. Even the Dutch health technology assessment (HTA) body itself, which advises the government on whether or not medicines should be reimbursed, feels like it is being held hostage by certain pharmaceutical companies. It is very hard for them to provide advice on the cost-benefit analysis of certain medicines, because they don’t know what the prices of those medicines are based on.
What measures would Wemos like to see put in place to effectively address the problem of highly priced medicines?
The government should propose measures that make sure that fair prices are being negotiated – that is to say, there needs to be a different system in place so that the government isn’t put in a position at the end of the negotiation process whereby it can only accept a high price. The government should be given access to reliable facts and figures about the costs of research and development of a particular medicine and what would be a reasonable price. In short, Wemos would like to see more transparency around how the prices of medicines are arrived at.
In the Netherlands, pharmacies have the legal option to prepare a medicine themselves instead of giving out a manufacturer’s product. This is sometimes done when the dosage of the standard manufacturer’s product is not suitable for a particular patient’s need but is also proposed when a medicine is considered too expensive for the government to reimburse. This is a legal option to temporarily and exceptionally not apply patent regulations for the sake of an individual patient or a small-sized patient group, circumventing too highly priced medicines.
Wemos also focuses on public return on public investment. Roughly one-third of new medicines are developed with the help of public funding, i.e. taxpayers’ money.2 The basic research is done at a university or another public institution. As such, we believe that the taxpayer should benefit. But at the moment, even publicly funded medicines can sometimes be assigned a really high price. That means the patient has to pay twice – first via their taxes for the medical research and then again through their health insurance for the medicines.
We don’t think that’s fair. And, again, it’s not transparent what the prices of these highly priced medicines are based on.
Thankfully, this message is being heard. Since the Dutch presidency of the EU in 2016 this has been a priority for the Dutch Government. The Dutch Government recently presented its budget for 2019, and one of its focus areas is to reduce the increasing costs of highly priced medicines. The Dutch Minister for Medical Care, Bruno Bruins, also recently proposed at the Informal EU Health Council that if companies do not perform the research for a certain medicine themselves, it is not legitimate for them to ask a really high price for that medicine. That was a very necessary proposal and it would certainly be a helpful way of changing the system and achieving more control over the pricing.
How does Wemos’ Medicines That Matter project work to ensure the value of new medicines entering the market?
Our Medicines That Matter project focuses on ensuring that all new medicines entering the EU market have an ATV. At the moment, many such medicines have little to no ATV, which means that they may not be more effective than existing treatments. We believe that all new medicines should fulfil a medical need, and that medicines that don’t are a waste of – often public – resources.
Clinical research that is carried out by pharmaceutical companies is often biased. Wemos would therefore like to see more independent clinical research and development. The processes involved in clinical trial design should be transparent and democratic. That would yield clearer results.
Wemos advocates for the European Medicines Agency to address not just the quality, safety and efficacy of a new medicine but also its ATV when making decisions about market authorisation. At the moment this is mostly done by national HTA bodies such as the one in the Netherlands. They look at the cost-effectiveness of a medicine and also related reimbursement policies. That ensures that if a new medicine is not better than an existing treatment, it will not be given a higher price. That is a good development, but we think it can be better.
What response to these proposals have you been met with from pharmaceutical companies?
In the Netherlands, you can certainly tell that a change is happening. Pharmaceutical companies know that the way things are done at the moment is not going to last – their reputation is under threat, and they are under pressure to be more transparent about their pricing. Just recently, it was announced that the pharmaceutical industry is working on a voluntary code of conduct to address issues like transparency on how highly priced medicines are developed and how prices are determined. It is clear that they recognise the importance of changing their practices.
That is certainly a good step, but at the same time I don’t know if a voluntary code – written by the industry itself – will be enough. There have already been a number of attempts to implement such guidelines, and very little has changed. If you ask Wemos, we think the government should take responsibility and implement a legally binding code of conduct in order to gain control of the pricing and ensure that new medicines have an ATV. That is why most of our work is targeted at policymakers, at the politicians and civil servants in the Ministry of Health and Economic Affairs, and European and Dutch parliaments.
More widely, how is Wemos working to ensure a fairer system of medicine development in the Netherlands and in Europe?
Wemos keeps track of the political debates on these topics and liaises with the media and politicians to ensure that the Netherlands is working to address highly priced medicines and ATV. We also work to make sure that measures such as compulsory licensing and independent clinical research are being discussed at the Dutch and European policy level and at the World Health Organization (WHO) and among the European Institutions, because the Netherlands cannot change everything alone. The government is willing to propose legislative measures to improve the system – in part because of a growing public awareness of the issues around new medicines – but it doesn’t want to run the risk of pharmaceutical companies deciding to stop selling their medicines on the Dutch market. It needs other European governments pushing for change, as well.
Indeed, it’s only by collaborating with one another and learning from each other that we can create the leverage needed to actually change the system – and we see a real opportunity to achieve this at the EU level. For that reason, the Netherlands has set up a joint pricing negotiation process with Belgium, Luxembourg, Austria and Ireland.
Together with the Dutch Cancer Society, Wemos has also created an informal network here in the Netherlands of organisations that work on medicines policy. It includes patients’ organisations, as well as organisations like Doctors Without Borders and Health Action International – organisations that look more towards developing countries. Wemos believes that any changes we make in the Netherlands will help to pave the way for measures on a global scale, which would be especially beneficial to low- and middle-income countries. For instance, if we were to introduce compulsory licensing of a certain medicine, other countries could do the same as it would fulfil a public health need. We are convinced that changes to our own medicines process would not only benefit Dutch patients but also open up possibilities for other countries as well.
Wemos is an independent civil society organisation committed to safeguarding health as a universal human right. It operates across three key areas:
- Financing for Health
- Human Resources for Health
- Medicines That Matter.
By holding governments to account, denouncing practices that undermine health or health systems, and advocating a health-in-all-policies approach, Wemos is at the forefront of efforts to protect and improve public health worldwide.
- Mapping of available health research and development data: what’s there, what’s missing, and what role is there for a global observatory www.ncbi.nlm.nih.gov/pubmed/23697824
This article will appear in issue 7 of Health Europa Quarterly, which will be published in November 2018.