 |
Harmonisation of Drugs |  |  |  |
 |  |
Dorota DULIBAN
The closer the end of the year is, the more alarming and catastrophic articles on withdrawing cheap drugs from pharmacies and drastic price rises of the remaining ones appear in the press. The blame for this impending alleged impasse on the drug market is put down to both producers and the harmonisation process itself to which we became obliged by signing the Accession Treaty.
Harmonisation is a common term referring to a complicated and costly process of adjusting medicinal products registration documentation to numerous European Union legal requirements. In 2002, preparing our country to the membership in European Union, a good number of fundamental changes were introduced to the act Pharmaceutical Law, where, by a faithful implementation of EU regulations, new requirements which a medicinal product should meet to go through the admission to trade procedure (in the past: the registration procedure) successfully, are described in detail and rather comprehensibly.
At the same time, completing the harmonisation process (one of its crucial elements is adding the bioequivalence certificate to the registration documentation) by producers guarantees availability of harmonised medicinal products in retail and wholesale trade after 31st December 2008.
This rigorous approach to the medicinal products market was supposed to guarantee Polish and other EU citizens access to effective and safe drugs.
Additionally, European Union, opening its market for us, required equality of standards in all membership countries, which has already brought profits and tangible benefits to enterprising drug producers. Signing, after many years of difficult negotiations, the mentioned Accession Treaty the Polish side agreed to adjust the Register of Medicinal Products Authorised for Marketing and their documentation to EU requirements, gaining in return a four-year interim period to do so. Then, the period seemed long enough for drug producers to complete the new more rigorous procedures which did not necessarily appear to be an insurmountable barrier.
We stepped into a new reality, which was opened for Polish pharmaceutical branch due to our accession, in optimistic moods. Open boarders together with unified rules of manufacturing and distributing drugs enabled us to derive benefits from our rightful membership. However, there is one problem left now - 31st December 2008 is a deadline for fulfilling one of the most difficult accession conditions imposed on pharmaceutical market - to adjust medicinal products registration documentation to the new law.
According to data of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, an institution responsible for carrying out the registration procedure in Poland (currently: admission to trade procedure) - the harmonisation process refers to about 8,5 thousand of medicinal products, including plant and homoeopathic drugs. A considerable percentage of them are products manufactured by domestic producers. Many of them have taken a very difficult for an entrepreneur decision to abandon documentation harmonisation for some of their products.
No one has questioned the reasons of such decisions because the cost of preparing complete documentation (dossier) for one drug only amounts to between 250 and 720 thousand zlotys. The amounts are often beyond some producers' financial means. A simple cost analysis is enough to prove it. Let's assume a company prepares dossier for 50 issues (drugs). The cost of the enterprise may reach nearly 40 million zlotys (for one producer!). Preparing documentation for one drug takes on average from one to two years and it needs taking on top experts and carrying out a lot of research.
It is obvious that a company manufacturing several dozen kinds of drugs is forced to make a selection and elimination based on technical capabilities to prepare documentation, likelihood to meet deadlines as well as economic reasons like profitability of keeping the production and employment level unchanged. Thus, anxiety connected with withdrawing some products from the drug market may be justified to a certain extent.
So far, harmonisation of registration documentation has been a problem and reason for concern for pharmaceutical companies and institutions responsible for the process (the Ministry of Health, the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products) only, but the closer the deadline (31st December 2008) is getting, the more and more information on the topic is getting to the public opinion. Unfortunately, the information in many cases is based more on speculation rather than on reliable facts, authorized by competent institutions. Undoubtedly, it was a serious mistake to keep a list of drugs with registration certificates expiring at the end of the year secret. Such a policy may surprise and evoke objections, the more so because the problem concerns as many as 488 products, which are refunded by the National Health Fund at present.
Absence of adequate information about which of these products have their counterparts in the reimbursement lists, and which have to be replaced by similar ones does not calm the atmosphere down. As it often happens, the media took over the role of state administration officers this time too and raised the hot topic. "Gazeta Wyborcza" of 23rd September 2008 gives a wide coverage of the problem including a short comment by the minister responsible for drug policy. The article also contains a list of products (from the reimbursement list) which are going to disappear from our pharmacies in some time. A soothing piece of information for a reader is that actually most of these drugs have their counterparts in the reimbursement lists. The problem, however, is that the material was prepared by a medical publisher and without questioning a probably reliable source of information it is hard to resist the impression that not everything is functioning well when it comes to the information policy of the health care sector.
Comparing the newspaper data with non-hidden data from the Office for Registration of Medicinal Products we can discover that about 260 products with an admission to trade terminating shortly do not have their counterparts in the reimbursement lists.
Irrespective of the quoted numbers, it must be stated that the Ministry of Health, should make up for the lost time and initiate a wide information action as soon as possible which would surely calm down the heated atmosphere and prepare both patients and doctors for the impending changes.
Even if some drugs can be easily and safely replaced, a doctor must realize that the situation forces him to do so and a patient must know that prescribed by his doctor drugs are available in the pharmacy.
A comforting fact, however, is that the end of 2008 does not mean the end of presence of the medicinal products whose certificates admitting them to trade are going to expire soon. Similarly to European Union regulations our Polish law guarantees the producers a so called clearance sale clause (klauzula wyprzedaży). Moreover, the Minister of Health and the Main Pharmaceutical Inspector have presented their stances in the matter taking into account the mentioned regulations. Therefore, all drugs with certificates expiring on 31st December 2008 may be in trade until their expiry date. Because many companies have decided to increase the production of non-harmonised drugs it
is logical to assume that shortage of these drugs shall become visible only after some time.
The problem, however, concerns the refundation policy, which - limited with very strict criteria - will probably not let the Health Minister to leave these drugs on the reimbursement lists.
It is necessary to add that unless the Ministry of Health changes the package of regulations including the reimbursement lists and excludes non-harmonised drugs from them, those which are still available on the market can be surely treated as refunded. Although information on planned corrections of the lists appears more and more frequently, this has been only in a form of news reports so far.
Therefore, we are looking forward to hearing the from the Ministry - and let's hope we will soon for the welfare of all of us.
Dorota Duliban - master of pharmacy; Main Pharmaceutical Inspector in the years 2002-2006