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Regulatory Reform Could Elevate Value-Added Medicines To Their ‘Rightful Place’, Says Narayan

Medicines For Europe Says EU Should Foster Patients Access To VAMs

Executive Summary

Medicines for Europe is calling on the EU to recognize value-added medicines as its own separate group in its pharmaceutical legislation.

Off-patent industry trade group Medicines for Europe is advocating for a defined place in the European pharmaceutical ecosystem for value-added medicines, giving them their own dedicated regulatory pathway and data exclusivity incentives.

This would be done through a new Article 10.7 of the EU Directive 2001/83/EC, which the organization has been recommending since last year. (Also see "Three Pillars Must Support Value Added Medicines In EU" - Generics Bulletin, 23 Feb, 2021.) Now, the European Commission’s Pharmaceutical Strategy and forthcoming revision of the medicines legislation represent a key opportunity to see these proposals enshrined in law.

Medicines for Europe has advocated for three pillars to the new legislation: a ‘fit-for-purpose’ regulatory framework which will allow for additional clarity in the early phases of VAM development; recognizing VAMs as a category of innovation with related incentives, such as a four-year period of data exclusivity; and recognizing and defining the value of VAMs by continuously shaping pricing and reimbursement rules to adequately assess continuous innovation. The organization has said the reevaluating the current model “should lead to greater focus on ways to stimulate innovation across the lifecycle of medicines, especially on off-patent molecules.”

Arun Narayan, Medicines for Europe’s chair of value-added medicines and global head of commercial development at Viatris, caught up with Generics Bulletin at the 4th Value-Added Medicines Conference in Brussels to discuss the challenges facing the VAM space and how the industry can respond.

What are the key challenges facing the value-added medicines space?

Value-added medicines do not have a rightful place in the European healthcare ecosystem, 70% of the global VAMs market, by value, is in US and only 12% of it is in Europe, according to IQVIA data and that is the biggest marker to tell us that there are challenges. These challenges are multiple: the first is a lack of clarity on the regulatory pathway to get a VAM approved, along with different advice from each regulatory agency about what evidence needs to be generated to confirm the value add. Challenge number two is that VAMs are not considered a type of innovation today that deserves incentives, from a regulatory perspective. But there needs to be some level of incentive to generate a reasonable return for companies developing VAM, because at the end there is a positive outcome which benefits patients, healthcare providers, the healthcare ecosystem and healthcare budgets. Those outcomes need to be recognized and they need to be incentivized.

The last part of that recognition is the pricing and reimbursement challenge, how to get appropriate pricing for VAMs and not get pigeonholed with the cheapest generic. The evidence, in many cases for VAMs, does not fit into the current methodology that Health Technology Assessment bodies use to assess the benefits of new medicines.

How can the industry respond to these challenges?

The response has to be bringing together all stakeholders to have an early dialogue on what makes the right framework, the right infrastructure, the right enablers, to bring VAMs to patients. We have ideas for new development, but those ideas are not making it to the patient. So how do we get across that bridge?

The first part is creating a fit-for-purpose regulatory pathway for VAMs, along with suitable incentives, which we are proposing under a new Article 10.7 of the EU Directive 2001/83/EC. This will allow for consistency in the approach of regulators, allow for efficiency in the way VAM dossiers/applications are assessed and most importantly allow for predictability in the whole process, which is one of the fundamental challenges that developers and manufacturers face when they think about VAMs. There are so many hurdles, there's so many unknowns that we have to overcome, so that’s how we need to respond. It is definitely a multi-stakeholder process to get to where we need to go.

What sort of regulatory approach would you hope to see Europe taking to VAMs?
The new pharma strategy offers an unprecedented opportunity for Europe to foster innovation by bringing in a legal basis for VAMs. What we are proposing is the new Article 10.7, to give the VAMs the boost they need in terms of predictability, clarity and coherence across Europe. It will also propose data exclusivity as an incentive, subject to the extent of data that will be brought into the submission, in addition to the other evidence that would be required.
Could the EU benefit from a more joined-up approach to the use of VAMs – I’m thinking specifically here about instances where one nation may permit the off-label use of a drug where another may not?
There are reasons for off-label medicine use in certain very specific circumstances, but part of the concept that VAMs are bringing forward is that off-label use needs to be converted to on-label indication. Now we need a pathway to do that and a clear way to convert off-label to on-label and to disincentivize the use of off-label where on-label exists. That clearly is an area where the EU regulators can play a major role.

How can the VAM space improve efficiencies when it comes to repurposing?

Again, it comes back to do we have a defined pathway? The whole idea of repurposing may come from clinical evidence, anecdotal evidence, researchers, academia… The difficult part is to take that idea, convert it to a product, get it approved, get it reimbursed and then get it to a patient. That’s where everything I spoke about in the answer to your first question is equally relevant – whether it’s repurposing, whether it’s reformulation, whether it’s combinations, we have the same challenge. Repurposing has been more in the news because of COVID and because of the RECOVERY trial and because of dexamethasone, but that’s not the only way to bring value to patients and to meet unmet needs without having to spend billions on new chemical entity-type research.

Which areas do you think could benefit the most from VAMs? Can you think disease area that particularly needs reimagining, for example?

A simple example is areas where there are challenges with adherence. We talk a lot about non-communicable diseases, and within NCDs we know that whether it’s respiratory, cardiovascular, neurology, all of them have challenges with adherence. That’s the most visible, obvious example where VAMs can make a difference, through reformulation and combinations.

There are many other examples. Converting a drug from one that has to be reconstituted at the hospital into a ready-to-use infusion or injection can help significantly reduce wastage and cost. Changing an IV to a subcutaneous injection can take the burden off the hospital and move healthcare closer to the home. Another example could be changing storage conditions of a drug, which can help bring down the cost of delivering healthcare.

How can the VAM space attract investment and stimulate innovation? 

I think the opportunities are already there. In order to incentivize the development of a larger number of VAMs, we need to solve those systemic issues that I talked about. Once there is a solution visible to developers we will see more investment and development, like we have today in USA

If we want for-profit organizations to participate in VAMs, the business case has to make sense. Otherwise it is only not-for-profit organizations and governments that will participate in this space, which is great and we will support in every way we can. If you take the example of dexamethasone with the RECOVERY trial, it was purely funded by government and philanthropy. Now there is a new indication approved for the drug and it is on the market, but that doesn’t happen in many cases. We need to find a way to create the right incentives to bring these opportunities to market.

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