After an extensive career in pharma spanning multiple geographies, Roche’s Managing Director for Greece, Anne Nijs, is now tackling the Herculean challenge of the Greek pharmaceutical landscape. She speaks about Roche’s focus on bringing differentiated innovation to market, the holistic approach of the organization amidst the crisis, as well as promoting structural changes to create a healthier healthcare future.

After an impressive 25-year career track spanning across a multitude of global markets at Pfizer, and having reached global level, what was the reason behind the bold move to Roche a year and a half ago?

I have spent my whole career in pharma, with an extensive 25 years in the field to date. My main driver is my willingness to learn. I identify as an eternal learner, who is also equally fascinated by different cultures. These two elements are clearly reflected in my career path, as I have moved across different regions and countries. This path has not only exposed me to different cultures, but also to different healthcare systems – ranging from highly developed to evolving environments. The ability to work and understand different environments has allowed me to better grasp which elements are transferrable from one context to another, in a variety of markets.

The main thing that drew me to Roche was the tremendous focus on bringing differentiated, innovative treatments to patients, which is evident to me on a daily basis. At the heart of this philosophy is the understanding that the treatments that we offer make a significant impact on the lives of patients with life-threatening diseases. This holistic vision is one that I have not witnessed anywhere else. Furthermore, from an operational perspective, Roche is a decentralized organization, which empowers its people. For the Greek affiliate in particular, given the current economic circumstances, it is a country that needed a seasoned leader. The organization was looking for someone who understands how to manage ambiguity, crisis situations and difficult operating environments.

Driving a sustainable business in Greece is my main priority. Sustainability for me is ultimately linked to patients’ access to treatments, so that Roche can continue to provide the high quality care that we have been providing for 38 years. My key mandate has always been to ensure that Greek patients continue to have access to treatment, in a viable way.

At last year’s FT Global Pharma and Biotechnology Conference, Roche’s global CEO, Severin Schwan, made a bold statement: “Declining R&D productivity, pricing, regulatory environment… When it comes to the challenges our industry faces, I could have presented you the exact same slide a decade ago. But if the challenges we face are the same, there has been a paradigm shift in the way we address them.” For Mr. Schwan, the path ahead clearly consists of cross-industry collaboration and mastering data complexity. How has this change in corporate philosophy manifested itself both at the global and Greek level?

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I am a firm believer that an organization that strives for real innovation will always find room for innovation. Innovation is intrinsic in our mission statement, which stipulates that we are “Doing now what patients need next.” This means that in parallel to bringing high-quality medicines to patients today, we also continually invest significantly in R&D to develop treatments that could be further differentiated tomorrow. Moreover, Roche is a company that is strongly driven by data. We rely on science and robust data to drive outcomes that bring substantial value to society. A paradigm shift is imperative as the industry needs to step away from the price debate to a value debate in navigating the challenges in the market. When the discussion is shaped around understanding the value, based on robust scientific facts, there will always be an environment that is ready to provide patients with this value.

I truly believe that Greece is a country that needs a long-term vision for healthcare – one that drives rational care and puts patients at the epicenter of the entire decision-making process. Today, the capabilities in the country are inadequate to make this transformation happen. Everyone recognizes that a shift needs to occur and there has been a plethora of discussion to this end, but the market currently lacks the tools for it to do so. As a result, the focus has largely been on horizontal measures, which have led to the implementation of clawbacks and rebates. However, it is important to be cognizant of the fact that the weight of these measures does not solely fall onto the industry, but also have an impact on patients, which is a fact that is often forgotten.

Locally, there is an element of needing to protect the local industry amidst the challenges faced in the crisis, which is a fair and justified objective, especially given the fact that the pharmaceutical sector is the second largest export industry in the country. However, when looking into how this can be accomplished, the methodology comes into question, especially in comparison to different operating models around the world. Currently, this protection is manifested through keeping the prices of off-patent and generic products artificially high. I truly believe there are measures and tools that can stimulate the local industry in terms of production and exports. There are models in other markets such as tax breaks and investment subsidies that bring an influx of activity to the local market. The advantage of a more liberal model is that there is no distortion to the pharmaceutical budget, as opposed to when prices are controlled. A more holistic approach is not only necessary, but also a more viable solution.

How is the global portfolio reflected in Greece?

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Roche Greece’s footprint is reflective of Roche’s global portfolio, with the entire portfolio in oncology and haematology being available in Greece, as well as an extensive specialty focus. We are also preparing to launch five new products in the near future, in line with the global portfolio. Additionally, there are 70 new molecular entities, i.e. potential future medicines, currently being developed in the pipeline.

With regards to the new products, the general framework is that it takes approximately one year after EMA approval for them to be launched in the Greek market. Greece has always been an environment that is very open to new treatments, which is strengthened by the number of physicians who are also very keen to adopt new levels of innovation and this has provided stimulus for Roche to invest in clinical trials. In the last five years, Roche has invested 22 million EUR in clinical trials, a large investment for a market like Greece. Roche clinical trials in Greece cover approximately 5,800 patients, which is a very significant figure, especially when considering that these are the number of people who get access to treatment before the medicines are launched on the market. The level of investment for clinical trials is contingent upon the propensity of the environment to adopt innovation quickly.

Although today’s environment permits launching new products, the status for the future is uncertain. There are two measures that are currently in discussions at the legislative level, which threaten the conducive nature of the environment. The first is to put a 25 percent rebate on all new products. The second is that the reimbursement of new medicines will depend upon the reimbursement status of these products in a specific, predefined number of countries.

These measures could consequently lead to a delay in products entering the market, which will have significant implications for patients. It is a grim reality for a patient, with a life-threatening disease, who knows that there is a cure available, but does not have access. Under these circumstances, the only other feasible option for a patient would be to participate in clinical trials, in order to gain access to treatment before it becomes commercially available in the market. However, in this scenario, investment in clinical trials could decrease. This will not only have implications for patients, but also for physicians who are heavily involved in clinical trials. Financially, decreased investments in clinical trials also indirectly means a decrease in investments in hospitals. Therefore, limiting patients’ access to innovation in Greece has a multitude of potential implications.

How are your efforts in investing in clinical trials perceived in Greece?

There is very strong recognition from physicians, patients, researchers, academia and payers who see the value from both an educational and economic perspective. Not only do patients have access – in the majority of cases free of charge – to new and innovative treatments, but also therapeutic options for healthcare professionals are enriched, scientific knowhow is enhanced, medical practice is improved, and research laboratories and centers of excellence are being created. Useful funds flow into the system and ultimately there is a clear benefit for the national economy. It is evident that the industry’s total investment in clinical trials can serve as a modern upgrading “tool” for the healthcare sector in Greece and at the same time as the “oxygen” for the Greek economy.

Another avenue for solutions is looking at the budget for hospital drugs. What are some of the potential measures that can arise in this respect?

It is true that the Greek healthcare sector is currently facing many challenges such as budget constraints and cost containment measures. That is why it is essential that all healthcare stakeholders partner and work together to pursue mutually agreed upon, sustainable solutions.

Our main concern as an organization is that the measures that are currently being implemented may not have a positive impact on healthcare in Greece. However, another area of prime concern is the implication of the decreased in-hospital budgets. One of the key issues is that budgets are not based on the real needs of the patients, as well as their future requirements. In 2016, the government decided to decrease the budget by 170 million EUR compared to 2015. The gap created by the decline will be covered through clawbacks from the industry. The general sentiment in the industry is that we are not totally against horizontal measures such as clawbacks and rebates, as long as they are balanced, transparent, as well as residual measures following the implementation of structural reforms aimed at establishing a rationalized healthcare system.

In addition to building a budget based on real patient needs, another area that may provide a solution is identifying and excluding product groups covered by hospital budgets that are not really administrated in hospitals. The budget needs to be corrected in order to ensure that it efficiently covers the necessary medicines. Moreover, there is a critical need to shift the discussion away from price to value in order to assess and build a budget based on a profound understanding of the value that medicines bring to patients and the healthcare system.

What is your overarching vision for Roche in the upcoming three to five years?

The vision is strongly anchored on my mandate to ensure patients’ access to innovation and build a sustainable business. From a leadership perspective, I truly believe that instilling a sense of ownership in each and every member of the organization is of prime importance, but it needs to be manifested through the Roche value system, which is based on integrity, courage and passion. Driving these values in cohesion, as a team will be a key ingredient to propel forward, in building a sustainable business.

Greece is a country that is indeed on the road to recovery. When looking at other countries that have emerged from their periods of crisis, a fundamental aspect for success has been their unwavering focus on healthcare. If healthcare is kept at an optimal level, the economic revival will be accelerated. My appeal to all the stakeholders in the market has always been to focus on the most vulnerable patients, who suffer from life-threatening diseases, in addition to their economic hardships. By ensuring that they have access to innovative treatments, the standard of healthcare could be elevated and the solid vision for a sustainable system could be achieved.