INTRODUCTION

1. Background to this study

Argos Translations (www.argostranslations.com) has been offering medical device translation/localization services since 1996. Over time, as our clients grew familiar with the translation services that Argos Translations offered, they began to request additional assistance in the medical device market. This occurred largely due to the fact that we were based in their targeted local market and thus could offer additional business support. Many of our clients not only needed their devices localized and their documents translated, but also needed to understand the regulatory issues connected with entering Central and Eastern European markets. Argos Translations understood that by being able to offer a turnkey solution that would include assisting in market entry as well as taking care of the translation/localization process, we would provide our clients with unique additional benefits.

As a result, Argos Translations joined forces with PMR Consulting, a local consultancy firm with the reliability and extensive experience that complemented Argos Translations service. The result of this collaboration is an offer of a complete solution for all medical device manufacturers interested in entering East European markets.

This white paper has been commissioned by Argos Translations and is intended to provide investors with information about the basic issues they will face when considering entrance to the Polish market with their medical devices. While some of the issues raised in this white paper may be common across other East European markets it is important to note that each country has its own regulatory requirements and thus it is important not to draw any far-reaching conclusions about the region without consulting a local expert for advice.

For more information about East European medical device market entry services or translation/localization services please send us an e-mail at: info@argostranslations.com

2. About Argos Translations

Argos Translations is a translation company offering high quality medical and pharmaceutical translation services for all the European languages with an emphasis on Eastern European support. Argos Translations is ISO 9001:2008 certified, has an international staff of 100+ in-house employees, over 1000 freelance translators, and a client list with numerous Fortune 500 companies.

Argos Translations has experience in translation of pharmaceuticals, medical devices & surgical instruments, biotechnology, in vitro diagnostics documents as well as medical software, articles for medical journals, and marketing documentation. The span of this experience covers areas such as translation projects that comply with the MDD (Medical Devices Directive), IVDD (In-Vitro Diagnostics Directive), and IFUs (Instruction for Use). Argos Translations clients include global companies such as Medtronic, Roche, GEMS, Biomet, and Siemens Medical.

The company, now in operation since 1996, has grown in size, experience and the diversity of its services. Argos Translations provides a unique one-stop business-to-business globalization solution for companies requiring translation, localization, desktop publishing, and consulting services.

3. About PMR Consulting

PMR Consulting is part of PMR Ltd founded in 1995. It is a British-American company based in Poland with a staff of 35 people, which provides consulting services in Central and Eastern European countries.

In the pharmaceuticals sector it has recently reviewed life sciences research options for a Scandinavian company, researched Central European Pharma sector companies for clients from Japan, France and Germany, and profiled oncology reagent producers.

PMR’s Managing Director formerly ran a company in Poland that represented a division of a leading US specialist medical-device corporation. His company implemented IT systems in hospitals and for the Ministry of Health. PMR publishes a bi-monthly magazine titled Polish Pharmaceutical News; a report on the OTC healthcare market in Poland, and manages the www.pharmapoland.com web site, as well as www.polishmarket.com and www.ceemarket.com.

LAUNCHING MEDICAL DEVICES IN POLAND

Since Poland joined the EU in May 2004 the level of interest in the market for medical devices has expanded considerably. There are two fundamental questions that any international medical device manufacturer should ask before attempting to enter into the Polish market:

1. Is there a market for their product in Poland, either in the state funded sector, where crumbling buildings and an atmosphere of financial crisis sometimes conceal surprisingly modern operating theatres and equipment, or in the small but growing private sector?
2. What has to be done to gain regulatory approval? The possibility of using existing European Union registrations to gain approvals in Poland is obviously of great interest. The additional good news is that Poland does recognize EU certification for two categories of medical devices.The less good news is that a number of hard to interpret forms (shown at the end of this white paper) may need to be completed (in Polish) and submitted to the relevant authorities in order to take advantage of the mutual recognition provisions. The status of each individual medical device (and whether documentation needs to be filed)should be carefully reviewed case-by-case. Furthermore, the situation with respect to enforcement of EU mutual recognition laws, is far from clear.

Is there a market?

In 2002 there were 739 general hospitals in Poland of which 678 were state-owned and the remaining 61 were either privately owned or controlled by non-governmental entities. Additionally, the Ministry of National Defense operates 24 hospitals and the Ministry of Internal Affairs and Administration operates 29 such institutions. There were only 3 more new hospitals added in comparison to 2001, but this was due to the fact that 16 new private hospitals started operations while 13 old state-owned hospitals folded. This seems to reflect a growing demand for higher quality medical services, as most state-owned hospitals are huge complexes, often with out-of-date and worn-out equipment and located in old, damaged buildings, some built more than a hundred years ago.

As far as the usage of medical devices goes, one recent study showed that 85% of medical devices available in 49 public hospitals in the Malopolskie region (area around Krakow) were in a “bad” or “unsatisfactory” condition, and there was not a single hospital whose overall medical devices were in a condition described as “very good”. Simultaneously 72% of all technical infrastructure was described as at least “worrying”. There is no reason to expect that the state of medical infrastructure of Polish hospitals is much better in the remaining 15 administrative regions across the country.

Other than hospitals there are also nearly 16,000 clinics where patients come to consult a doctor or have minor treatments. These medical units (of which 76% are privately owned) vary in size and most of them are staffed by just a few persons. The medical devices used in private clinics are often quite good while their state-run counterparts often use older equipment dating back to the 1960’s or 1970’s, which is highly damaged and even defective due to overuse and poor servicing. However, higher priced equipment is often only available in the state funded hospitals (being beyond the reach of most private clinics). Private clinics form an unofficial gateway to provide queue busting access to the most expensive medical kits offered sometimes only in the better funded hospitals, located in any given town or region. How does this occur?

Simply put, a patient pays 50-100 zloty (5-10 Euros) to see a specialist in a private clinic. There he is told (if necessary) to show up in a state hospital when that same specialist is there on duty. The client then calls that same doctor/specialist on his mobile phone, who then fixes a second appointment on expensive hospital equipment that is not available in his private clinic.

Poland will have to upgrade its health care system as its population ages. This together with the relatively poor health of many of its inhabitants, creates a reasonable expectation of sustainable and increasing demand for many types of medical devices. In some cases European Union funds that Poland (and other new member states) are now entitled to, may be available to subsidize some of the costs.

Altogether, this means that Poland is likely to be a growing market for medical devices over the next few years because, investments in medical technology are a necessary part of the process of bringing the national health care system up to European standards.

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