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Did the Office for Registration expect such a high dropout rate?
• No. When we made a request to responsible entities for initial information on the subject of the number of medicines to be harmonized, they returned a number of around 9500. With hindsight it can be seen that the Office’s request for data was not treated seriously by the responsible entities, which replied without much care and just to “get us off their backs”. However the Office tried to plan its work based on those surveys. Luckily we did not act solely on the basis of those results, but also took account of our own market research, and we were thus able to avoid problems.
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There are those who say the days of cheap medicines are over. Is this true?
• I think these views represent a kind of artificial hysteria. There are large changes in the prices of medicines. Many factors affect the level of medicine prices. They are mainly influenced by competition among manufacturers, the market situation, whether or not a particular medicine is subject to refunding, and so on. For this reason I believe that all claims of this type are untrue, and that the medicines market, even though it is regulated, is governed by similar mechanisms to other markets. •
interview
a document is produced – maybe an invoice, maybe a warehouse transfer document – confirming that the medicines have been moved from the manufacturer’s warehouse to a wholesale warehouse. In the case of medicines coming off the market as their validity periods expire, there may exist a paradoxical situation where a harmonized and non-harmonized medicine remain on the market for the same length of time, since a non-harmonized medicine can remain valid for five years, the same as a harmonized one. Only after five years is it possible to apply for indefinite validity of a medicine.
The Health Ministry has prepared a new draft law on registration, making a number of changes in the way the Office functions. The draft is currently undergoing a process of social consultation, and ought to be placed before parliament in September, once it has been approved by the government…
• True. Discussions are currently under way. We will see what the results are. We have to remember that there have been two similar previous proposals, but they failed to get through parliament. For that reason I take a somewhat sceptical attitude to this. We will see what comes of it this time. Interviewer: Robert Miller
Maciej Głowacki, Chairman of the Board Polfa Warszawa for „World of the Pharmaceutical Industry” on the harmonization process Without doubt the process of harmonization has been and remains essential. Its ultimate objective is the good of the patient, who ought to receive safe and effective medicines that fully comply with European quality standards. Accepting that objective, we took a decision to harmonize the documentation for the vast majority of the medicines produced by Polfa Warsaw. This decision inevitably led to high costs being incurred, more than 50 million zloty so far. Over that time we have also taken decisions not to go ahead with the update of certain of our medicinal products. The reasons for not harmonizing these products were varied. Sometimes it was because it was impossible
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to bring the existing documentation into line with the requirements of the Pharmaceutical Law. This applied in particular to older-generation medicines, which pharmacologists had asked to be withdrawn from the market due to their low effectiveness, insufficiently documented therapeutic indications or safety of use. Other reasons included technological problems with the production of a substance, problems with the documentation of certain ingredients, and non-compliance with the company’s product strategy. Economic factors (usually low sales of a particular product) were among the reasons behind decisions not to go ahead with the harmoniza-
tion of certain medicines. However it seems unfair to claim, as has been done recently in the media, that in taking decisions not to harmonize some medicines the pharmaceuticals companies have been guided by financial considerations alone. At Polfa Warsaw that was certainly not the case. I emphasize that it was one of the factors, but certainly not the decisive one. Polfa Warszawa SA is and will remain a manufacturer of medicines accessible to all patients. In 2007 we were the fourth largest firm in the market in terms of number of packages sold, but only seventeenth in terms of their value. These figures speak for themselves.
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