Interview Pharmaceutical market

Our drugs are a great example of how innovation works and how we can make a meaningful difference in people’s lives

Martin Franz Werschlan, the CEO of Roche Ukraine, shared his many years of experience in the medical field, in particular at a world-scale Roche Company. Noteworthy, the enterprise started its activity in Odesa (1898). So, it has been present on the territory of Ukraine since the end of the 19th century. In his interview with , Mr. Werschlan outlined the significant innovative developments in the production of drugs that can help patients improve their quality of life. He also noted that close cooperation with the state is crucial for the effective functioning of the Ukrainian medical sector.

: You became the head of Roche Ukraine not so long ago. What plans are you going to implement in this position? What challenges are you anticipating?

M. F. Werschlan: In my opinion, it’s all about creating better outcomes for more Ukrainian patients faster. This is our corporate mission and I personally profess it. As for challenges, we need to closely collaborate with the authorities and government to create better outcomes for Ukrainian patients. Currently, this cooperation is not as close as it could be. We are working rather at arm’s length with each other, given the current procurement and tender regulations. Creating a true partnership with the authorities is probably one of the biggest challenges for us. For example, we provide treatments for complex diseases, which require multifactorial and integrated solutions. The whole process starts from disease awareness and education, moves on to diagnosis and the actual provision of treatment and often requires administrative, emotional and mental support for patients as well. However, our current relationship with the authorities limits us to the provision of the drug and nothing else. That’s why it is difficult to create a fully integrated solution. We need to get much closer to the authorities to achieve better results for patients. This is the main challenge.

: Could you please briefly tell us about yourself? What was your professional path before deciding to work in Ukraine?

M. F. Werschlan: I am originally from Switzerland, the central German-speaking part of the country. I joined this company right after my graduation from university and really had never worked for any other companies except for my student summer jobs. I have been working for Roche for 22 years.
I love Switzerland but I have always had a feeling that it’s a bit small for me. I was eager to go abroad, and so I did. I have been working in multiple countries for almost 20 years, mostly in Finance and IT project management. I started my career as an internal auditor, and then moved to South Africa as a controller for our Diagnostics division, next to Germany, China, Colombia / Ecuador and Argentina / Uruguay. I’ve spent my last 7 years in regional CFO positions, first in the Eastern Europe, Middle East and Africa region and then in Latin America. My position in Ukraine is my first General Management assignment.

: In your opinion, what is a limiting factor that does not allow us to actively introduce innovative approaches in healthcare?

M. F. Werschlan: The main factor is one I have already mentioned – the way we interact with the government. Besides that, we are committed to engaging with the authorities in value-based agreements and can share the risk with them. I fully understand that any administrative body, be it a public or private one, wants to ensure that their investment in healthcare will pay off. We are often facing the challenge that the evidence created by a clinical trial is not enough to support a healthcare policy decision or a decision to approve funds for treatment. The authorities increasingly want to understand the effect of treatment in the real world before taking any decisions. At Roche, we are prepared to engage in such discussions. However, we need to integrate real-world patient data into our business model to make such agreements work. The availability of such data is critically important, but we also need to have a certain level of trust to share and exchange this data with the authorities. Therefore, we should come up with new ideas and tools to bridge this gap of trust. At the moment, this an obvious limiting factor.

To sum it up, the lack of trust is limiting us from bringing innovative approaches to life. We are too far from each other.

: How is the company now working with the state to solve the problem of ensuring the availability of effective treatment for Ukrainian patients?

M. F. Werschlan: There are actually some activities, but not as many as I would like to see. For example, we are currently cooperating with a local partner and provide locally manufactured products – so-called secondary brands – to the authorities and the state. This is a special access program to help the state access monoclonal antibodies at a more affordable level and provide some jobs, investment and technology transfer into Ukraine.

We also have a lot of clinical trial activities here, which transfer knowledge and investments into the country. These activities are the most important. I’ll probably repeat myself, but the direct interaction with the state is limited. I wish we had much closer cooperation with the government to make a positive difference in the Ukrainian healthcare system.

: The company is actively working on streamlining access to innovative and effective drugs in Ukraine. What results have you achieved so far? What are you planning to do in the near future?

M. F. Werschlan: I would like to emphasize that we can register new drugs quite quickly and that is a strong point for Ukraine. We are also able to quickly register trials here. It commonly takes much longer in other countries. Whenever we get a new drug registered, for example, in the US or Europe, we can follow suit right away in Ukraine. This is a positive thing.

On the other hand, it is difficult for us is to gain funding for a drug. Patients have to pay for themselves and this is a challenge. For private patients who pay out of pocket, we have implemented the so-called “patient support programs” which help them to get access to significantly discounted vials to continue their treatment.

These are already implemented and achieved things. We are also negotiating to improve patients’ access to drugs. However, I’d like to highlight that it is still at a preliminary stage with the government.

: Are there any products presented worldwide but not in Ukraine?

M. F. Werschlan: Perhaps some of the older products are not available in Ukraine but all of the recently launched products are brought to the country as well. I would like to emphasize that we have a single product portfolio. We do not have separate product portfolios for the US, Europe, and other markets. We have a sole strategy and focus exclusively on innovation. We do not do generics, a copy of synthetic molecules, or biosimilars – copies of biologic molecules. Roche is dedicated exclusively to innovation, and this is our single strategy for the whole world. We have only one standard.

: Many pharmaceutical companies discuss innovations. What does innovation mean for Roche?

M. F. Werschlan: For me, it is part of the company’s DNA. If you look at the value of such a company, you can notice that it is all driven by intellectual property. What is the market capitalization of such a company? What is driving it?

Future cash flows of the products in development are all driven by intellectual property. There is nothing you can touch like a table; there is no company like a gold mine with a physical asset like gold. It is intellectual property. Think of it: Where does it come from? Well, it comes from the people’s brains, from the passion of those who really put all their energy to develop this innovation. This is the company’s foundation, part of its culture. I always like to think of it that way.

It is not something only applicable to research and development. We want innovation in the support functions and every other. It is all about developing a new drug. If someone from the accounting department tells: “I could use a process robot, for example, to generate our travel reports”, this will also be an innovation. If we can use the blockchain technology to implement our outcome-based agreements with the government, this is also a market access innovation. It is absolutely everywhere.

: Could you please share the annual amount of investment in research?

M. F. Werschlan: Globally, we allocate nearly $10 billion per year for research and development activities. I think it is the highest rate in the industry.

: What innovative Roche products are you proud of?

M. F. Werschlan: There is a couple of products I am proud of. If I had to highlight just one, I would choose our innovative drug used for the treatment of hemophilia patients with and without inhibitors. We are launching this product now and it is already available in the Ukrainian market. Why did I mention hemophilia? It exemplifies and describes the way innovation works in many ways and represents the goals of our company.

Our molecule originally came from Japan, Chugai, our Japanese subsidiary, and was integrated into our development platform. Let me explain briefly. We run a decentralized innovation approach. We do not believe that innovation has only one source. Multiple research centers are working in parallel. We sometimes get criticized because this is not as efficient as it could be. Nevertheless, the fundamental belief is that innovation can come from anywhere and needs a certain level of independence to flourish. That is the main reason for running the parallel innovation approach.

So, this new Roche product for the treatment of hemophilia patients represents the success of this model. It brings breakthrough therapy in terms of the outcomes it has because it dramatically reduces the bleed rates for juvenile and adult hemophilia patients. It opens up a new level of quality of life. Just imagine if you had hemophilia, you were born with this – and this is an inherited disease. Some patients need multiple weekly intravenous infusions with factor VIII to supplement an enzyme they are lacking in their blood clotting cascade. These infusions sometimes take up to several hours. And if you had a kid suffering from this disease, you would need to spend plenty of time every week to do infusions, so your entire life would be focused on the kid’s disease. Both you and your kid would not have a normal life. And now, thanks to Roche innovation, you have an effective drug. Instead of infusing several times per week, one can have a subcutaneous injection from once a week to once a month. It is a different level of quality of life.

These are better outcomes – not just medical results but the entire new quality of life of these patients. It also affects the long-term effects because if hemophilia is not treated properly, patients’ joints can suffer damage from continued bleeding. Finally, these people will need a hip or knee replacement that causes additional costs for both them and the entire healthcare system. All this can be avoided, which is great for society in the long run.

That is why, if you ask me what drug I am proud of, I would like to highlight our new molecule for hemophilia treatment many others we have at Roche. It makes a huge change in the quality of life of patients and their families. That is why I am proud of it.

: What drugs are you going to release in 2020?

M. F. Werschlan: In November, the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the new Roche molecule – “first-in-class antibody-drug conjugate” in Hematology that specifically targets a protein expressed in the majority of B-cells lymphoma. In 2020, we expect the Global Launch of this molecule and registering it in Ukraine. This is the second drug of this kind – a combination of a targeted monoclonal antibody with classical chemotherapy, which we already have for HER2-positive Breast Cancer – it was the first. We also have a new drug with a new active mechanism that works against influenza, so it may be used in the flu season. We believe it’s also a great contribution to Ukraine with its climate and winters, which are right about to come.

These are the most important things for 2020. Besides, we have line extensions for cancer immune therapy, which are also coming soon.

Please read: If a company wants to avoid problems with assets and controlling government bodies, it is necessary to establish a unified and consistent communication strategy for all authorities

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