Interview: Riho Tapfer – Director, Association of Pharmaceutical Manufacturers of Estonia (APME)

Riho Tapfer, director of the Association of Pharmaceutical Manufacturers of Estonia (APME), explains that a modern healthcare system and better medical care will require the widespread adoption of electronic health information which, in turn, allows for changes in important areas including prevention and more personalized care tailored specifically to a patient’s genetic profile and needs.

In 2007, APME and the Estonian Generic Medicines Association (EGMA) merged, which is something that we have not experienced in the other markets where we went. Why was that?

“If we have one advantage compared to other countries in the EU is our clinical excellence and the cheap operational costs and to this purpose Estonia should look to attract more CROs.”

Estonia is a very small country and a minor pharmaceutical market, so it was financially unsustainable to keep two separate associations. As you say, at the general meeting of APME on the 14th of May 2007, APME and the Estonian Generic Medicines Association (EGMA) merged. Prior to this, the two associations already had a joint code of Good Marketing Practices (GMP) and for supervision over compliance with the code also the Ethics Committee of Pharmaceutical Manufacturers. In my view, the business model for generic and innovative pharmaceutical companies is not very different and the ethical standards are very often the same.

We do not have a conflict of interests. Our goal as an association is to promote the patients’ awareness of healthcare and disease prevention as well as of treatment options and the use of medicinal products and to secure the balanced development and stability of the Estonian medicinal products market, which involves the protection of intellectual property, promotion of innovation and ensuring a market-environment that is conducive to free enterprise and fair competition.

How would you describe the mandate and the main role of the association?

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First and foremost, to provide a unified voice for the industry. APME is a publicly respected organization which represents and unifies all ethically exemplary pharmaceutical manufacturers in Estonia by promoting best patient care, stabile healthcare system and protecting the image and interests of its members.

How difficult is it to engage with the government when it comes to reviewing legislations?

We often have a seat at the same table. For instance, at the moment we are reviewing together the falsified medicines directive which is one of the most significant piece of law for the sector in Estonia. However, if we look at the current Minister of Health, I am not sure whether he sees industry as an opponent or if he sees us as a trusted partner able to bring solutions. Sometimes, I truly believe that he is the very first Minister in my 25 years health sector experience who does not value the industry as it should. However, image per se is not valuable, and I do not have an interest in projecting a much better image of the sector in the country – actions and results is what matter at the end of the day!

How would you evaluate the ease of market access in Estonia compared to the other two Baltic countries?

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Market access is our mission number one. The second is to keep ethical standards at a high level. The ease of market access, not only in terms of registration but also in terms of reimbursement, is not the worst compared to other Baltic states. There is a list of medicinal products that are either completely or partially compensated which is adopted by the Minister of Social Affairs and reviewed regularly once in three months (1st of January, 1st of April, 1st of July and 1st of October). EFPIA regularly carries out an in-depth analysis of the availability of new medicines in countries over a period of three years – in the EU region during last 3 years period we had about 140 medicines available, only 21 percent available in Estonia. Needless to say, that this is a problem about money but not solely.

Estonia is very much down the line to go towards personalized health. How do you assess this situation?

The role of e-health is playing a very important role to this regard. I believe that on the one hand, the health insurance fund that is collecting data is doing a phenomenal job in aggregating them and make them fit for purpose; on the other hand, we have hospitals that provide 100 percent electronic information for medical professionals and patients. In Estonia we truly believe that a modern healthcare system and better medical care will require the widespread adoption of electronic health information which, in turn, allows for changes in important areas including prevention and more personalized care tailored specifically to a patient’s genetic profile and needs. The use of data is also a way to make Estonia attractive for big pharmaceutical companies to come and invest in our country.

Estonia is a very small market and, in such cases, there is always a limited interest by pharma companies to come and invest. How could Estonia make itself more interesting to this type of companies?

If we have one advantage compared to other countries in the EU is our clinical excellence and the cheap operational costs and to this purpose Estonia should look to attract more CROs. However, I am little bit sceptical when it comes to gene-based and personalized care in the foreseeable future, although I recognize that Estonia has a great potential and is regarded as a pioneer in this field in many parts of Europe. As you say, Estonia is a small country and one of the benefits of small markets like this is to try and test things out because of the size and lack of complexity. Estonia is certainly a country that could be used as a testing ground.

What is the contribution of the pharma industry to the Estonian national economy?

The major contribution comes from the clinical research from pharma companies which are present in our country. While we do not have data proving this, the entire segment is valued at about EUR 20-25 million. If, on the one hand, we can invest this money in treatments, it also provides high-quality employment.

When we come back to Estonia in five years time, what will you have been able to do from an association point of view?

I would like to believe that in five years’ time availability and distribution of medicines is much more of a centralized EU mechanism, I hope that we will have many more data to carry out HTA activities and that performance-based healthcare will become Estonia’s future.

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