Банкеръ Weekly



People in Bulgaria seem to have got used to the idea that the European Union membership of the country will affect their pockets. However, the general trend toward living a more expensive life has a few serious exceptions. One of them is the medicines sector in which the equalization of Bulgarian prices with the European ones means in fact reduction of the prices. Experts are firm that now about two thirds of the imported drugs are sold at higher prices in Bulgaria than they are in the western part of the continent. Thanks to the bill on medical products in human medicine approved by the Government, this absurd should be removed. For example, the bill stipulates that price-making in Bulgaria be coordinated with the EU Transparency Directive 105/1989.
Medicine prices will not be fixed
Marginal tariffs will be registered and in the case of prescribed medicines they will be confirmed by a special commission after being compared to the levels in selected nine EU member states. When a similar reference methodology was introduced for the reimbursement list in 2003, the National Healthcare Insurance Fund (NHIF) managed to save about BGN25MN.
The price reduction will also be favoured by the introduction of the so called parallel import. Every wholesaler will be allowed to import to the Bulgarian market a foreign analogue of a drug from the EU. The Medicines Executive Agency will be obliged to give him (or refuse) respective permission within 45 days. The reason is that usually imported products appear cheaper and will press the prices of other medicines, too.
This is a mechanism created by the European Commission for equalization of the prices of drugs with the same quality and quantity composition. We plan to achieve equalization with the European prices in 2 or 3 years after the parallel import is introduced, Dr. Emil Hristov, Executive Director of the Agency, explained. This import will be the main mechanism through which the Ministry of Healthcare, the medicines agency and the healthcare fund will conduct rational drug policy.
A main advantage of the act
which all producers and dealers underline is the shortened term for price-making and including a medicine in the reimbursement list. In the future, new medicines will be offered on the market for six months and not in 2 or 3 years as it is the tradition now. We should neither forget that drugs for treating oncological diseases, hi-tech and biotechnological products are subject to permission from the European Medicines Agency (EMEA). In the coming ten years the agency will also be supervising medicines treating AIDS, socially significant and infectious diseases which will shrink the functions and will facilitate the Bulgarian Medicines Executive Agency.
The bill will also enable the issuance of national permission valid on the territory of Bulgaria alone, as well as the mutual acknowledgement of permissions between medicines agencies in various member states.
According to the so called excessive data protection, an original medicinal product cannot have a generic copy ten years after it has been launched on the territory of the EU. However, as soon as the tenth year expires the same medicine can appear on the market with another brand and a much lower price.
Particularly to producers and dealers
2007 will be a year of great tests
Within three months following the country's integration date, the Medicines Executive Agency will have to write in the single European register all permissions issued in the country for production of medicines. Each European medicines agency, EMEA included, will be allowed to freely inspect Bulgarian plants and will implement permanent supervision. We are going to buy medicines from different batches at random, make analyses and confirm whether or not the declared procedure is fulfilled, Emil Hristov specified. The principle is - free access of the producer to the market and successive control and not as it used to be so far - very strict requirements for giving access to the market and then almost no control.
Each producer or wholesaler registered in the EU will be allowed to exercise his activities in Bulgaria. A benign registration regime is about to be introduced. The new bill gives producers the right to be importers and distributors of their own products as well, but not to own pharmacies - neither directly nor through related people under the Commercial Act. Which is much different from the current situation.
The changes under preparation will also put an end to the growing trade in pharmaceutist certificates. The document will be obligatory for pharmacy managers only and not for pharmacy owners.
Stricter regulation is also planned towards
clinical studies on children
They are forbidden in Bulgaria now, unless results from clinical tests made on adults be transferred to children. However, there are quite many cases of this kind.
I do not accept evil-minded qualifications that our children are becoming guinea-pigs, Dr. Margarita Gizova, Chairwoman of the specialized commission on permitting clinical studies, commented for the BANKER weekly. Studies on ill children of the kind have been conducted for a long time and will continue not only in Bulgaria, but also in all EU member states, in the USA, Canada and Latin America. These are not experiments but clinical studies with different kinds of medicines in cases of special diseases only at the age for which they are most typical. The US food and medicines agency which is the strictest in the world permits them, too. Clinical studies on children that are made in the country have been subject to extremely strict requirements.
Tightening the control over production, preservation and trade of medicines is also related to a
considerable increase of the fines
Most sanctions will grow up to ten times and the highest of them will amount to BGN50,000.
Of course, we can only expect results from the above-mentioned measures after the National Assembly adopts the bill. Some of the amendments will hardly be voted easily since they concern the interests of companies that have strong lobbies in the authorities. Additional difficulties will arise from the 23 regulations that accompany the bill. Still, members of the Parliament do not have much time - the new medicines act should be valid from the first day on which Bulgaria enters the European Union.

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