Pfizer Slovakia’s Country Manager and Lead Internal Medicine / Pfizer Innovative Health Branislav Budke discusses the success of Pfizer in Slovakia, the challenges of the healthcare system, and political changes that can potentially contribute towards the easier market access of innovative treatments, due to his dual role as Head of the AIFP, the country’s Association of Innovative Pharmaceutical Industry.

As president of the Association of Innovative Pharmaceutical Industry in Slovakia (AIFP), could you please talk us through your main ambitions and the main challenges the association is facing at the moment?

I have been active in the association’s activities for more than seven years. Our first mission with my peers was to rebrand the association five years ago not only by giving it a new name but by restarting of the association with full scope of activities and also by adding new members. At the time, I was a vice chairman, prior to becoming chairman of the AIFP in December, 2015.

As you know, there are a lot of political changes and movements in the Slovak healthcare system at the moment, with the appointment of a new Minister of Health Tomas Drucker last March. The Association has therefore been very much focusing on a positive dialogue with the new administration. My ambition is for the Association to become a partner for the government in drug related policies and issues. As an industry, we call for open discussion based on facts and analyses and we are glad that the new Government seems to respond to that. AIFP was invited to become a member of several working groups at the Ministry, dealing with important changes in the Slovak healthcare system.. We promote innovation, transparency and patient centricity. The association is strongly supported by the EFPIA (European Federation of Pharmaceutical Industries and Associations) as well as our members who dedicate a lot of resources, mainly human resources and knowledge, towards the vision and effective performance of the AIFP.

What have been the highlights over the last seven years you have spent with Pfizer as a General Manager?

Each and every year has been different! The market, the industry and Pfizer itself have gone through a lot of dynamic changes and transitions during this time. There are a lot of patients whose lives have been improved because of Pfizer’s treatments. Moreover, employees of Pfizer in Slovakia are dedicated and have strong values which makes me as a General Manager happy about the corporate culture that we cultivate in the company. I am sometimes asked if I want to engage in a different experience and company after seven years. The answer is no. Every single year as my term as Country Manager has been unique and I appreciated every part of it.

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What are the key priorities for Pfizer Slovakia at the moment?

I would qualify them as four main objectives: to be successful with our innovative pipeline and allow access to such products by the Slovak people, meet market needs, improve access to medicine and balance diversity of our portfolio. We have a lot of innovative drugs, established drugs and drugs in various life cycle stages which require a complex country management and market access approach. Therefore, my priority is to control operations while proactively shaping conditions in both the environment and the industry.

How would you evaluate market access in Slovakia for innovative products?

Broadly speaking we have a good access to medicine but of course it depends to which country we are compared to. Taking the CEE (Central Eastern Europe) cluster, Slovakia is a developed and established EUR 1.25 billion (USD 1.4 billion) Rx market, a similar figure to Romania which has 20 million inhabitants – whereas we are 5.4 million inhabitants. Furthermore, Slovakia is looking for new ways of drug categorization for new medicines to be included in the standard reimbursement list.

Nevertheless, biological therapies in oncology used to be affordable for patients and physicians, and after expenditure grew quite fast, the government introduced restrictive measures to keep the budget under control. In 2011 a new legislation promoted very strict regulations for pharma and healthcare professionals. As a result, access to innovation is now restricted. Out of last 150 new molecules approved in the EU, just 30 have reimbursement in Slovakia. Many companies do not even apply for reimbursement because meeting the set of requirements for cost effectiveness is often impossible. In Pfizer, we promote transparency and have very strict standards thus, we have not been affected that much.

Additionally, there is an alternative way of how patients can get access to medicine. In exceptional cases, health insurance companies can approve a specific innovative treatment to a specific patient. The health insurance budgets dedicated to such exceptions have been growing over the years. However, the system is neither transparent nor predictable, and requires standardization. Hence, my priority as a chairman of the AIFP and a country manager of Pfizer is to contribute to improvements in this area. We have initiated dialogue with the ministry of health so that the reimbursement system is changed to make it more transparent, standardized and predictable. There is a working group at the Ministry of Health which accommodates the conversation and is willing to listen. This is a huge improvement after a few years when pharmaceutical companies had hardly any conversation with the Government.

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The industry is also putting a lot of effort into fixing the reputation of pharmaceutical companies and initiating a positive dialogue with the authorities, with the ‘win-win’ approach for both parties in mind. In order to do so, EFPIA and AIFP have adopted a “Disclosure Code” which requires all member companies to disclose any transfer of value between them and healthcare professionals or organizations.

The issues that the Slovak government is facing when it comes to market access are very similar to the other countries struggling to find budget to provide patients with the best innovative medicines. What role does the industry must take in the pathway to sustainable healthcare?

There is no easy answer to this question. At Pfizer, we are open to certain models which would enable us to have managed contracts with the government or enable us to have contractual relationships with health insurers. Slovakia is a small country, and currently has some of the lowest prices of medicines in Europe due to the international price referencing. One of the things we need to establish is a platform to have contracts between companies and healthcare insurers. I am not in favor of pure financial management agreements as it leads to issues that Romania and Hungary are facing at the moment. We should look for the approach that would combine financial and outcome based benefits.

Market conditions in Slovakia are very complex and cannot support more sophisticated benefit models for innovative drugs, as it is done in the Netherlands or France for example. It would be very easy for a regulator to implement a pure financial agreement but we are trying to create a model to include different criteria and a mixture of approaches that would work for the country. It is a very hot topic as in September AIFP submitted a proposal to the Ministry.

Strategically, how important is the Slovakian market to the overall region for Pfizer?

Pfizer Slovakia has a very good position if you look at our revenue per capita. We are much higher than in other countries. Good performance is determined by the access that we gain but also by the fact that we know how to do business in the country. Our focus lies not only within the business targets but in the contribution that we provide to society, our partners and patients. Despite the limited size of our market, it is no doubt that Slovakia is an important country within the region.

It seems that Pfizer has understood how to do business in Slovakia. What unique characteristics should be navigated? What is the key to success?

This market is still very much prescription driven where physicians have a strong influence. To be successful, you have to work with both the authorities and the healthcare professionals. Companies like Pfizer have a unique standpoint because our medicines are very good quality and have a proven record of providing benefits to patients. This is a sustainable solution, and I strongly believe that there is no short-term way of achieving success. In Pfizer, we support all the different stakeholders: patients, patients’ associations, the medical community and KOLs, as well as the authorities.

Moreover, we bring know-how factors and clinical trials. We have great physicians here – the quality of education and medicine being very high. The perception of medical doctors is sometimes affected by the lack of financial resources, which means poor conditions of hospitals and equipment. Yes, the hospital infrastructure still has much room for improvement. That being said, the provided quality of medical care is still very good.

Clinical trials are at a very high level; we conduct more than 40 trials in Slovakia. These are also late stage trials with molecules which are very important for the company. With the support from the region and the government, we will keep investing in clinical trials in the future, as Slovakia is an excellent option to do so.

In terms of products and therapeutic areas, what are the main value drivers for Pfizer in Slovakia?

There are several groups of medicines and priorities for the company. As we have a broad portfolio and have been acquiring a lot of companies in this process, it includes areas in cardiovascular, oncology, rare diseases as well as vaccines. In terms of products Eliquis is doing well and we also have new products to be launched in oncology for breast cancer treatment.

Pfizer is very embedded in Slovakia not only in terms of your capabilities but also the contribution to community with projects such as Land of Saviours. Could you give us a few words about that?

Three years ago, I met with the Red Cross and a local PR agency to understand how we can improve awareness of first aid delivery. We have created a project which promoted a new way of education in giving first aid. It was not about the pharmaceutical industry per se, but rather the education of society. The Ministry of Health got on board and the initiative was recognized amongst different stakeholders in the industry as well as a number of awards. The most important recognition came from the President of Slovakia. This naturally represents a significant investment for Pfizer, but I felt this was necessary for a company like ours. We need to give back to society and this is one of our key missions.

A few words to conclude Mr Budke?

When speaking about new innovative treatments and the pharmaceutical industry, it is important to evaluate the value of innovation through transparent and simple processes

When speaking about new innovative treatments and the pharmaceutical industry, it is important to evaluate the value of innovation through transparent and simple processes. Strategic forward thinking of how to finance future innovations in the scope of a ten years’ framework should be taken into consideration.

There are pipelines of gene therapies and we should think now how it can be financed in the future. Gene therapies are based on long term views, and we cannot afford to have a medium term insight. The reason why we are facing the challenges discussed today is because of the past mistakes and lack of thinking towards the future we had in the past. Finally, I would like to highlight the fact the industry needs to continue collaborating with the wide variety of different stakeholders in Slovakia to ensure patients and the Slovak people in general have access to the latest innovations.

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