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User fees for pensioners should not be increased, but a way should be found that they are compensated. To increase the tax for the rest of the people is also not a solution. He indicated that in most European states there is alleviation for seniors.

To say nothing that there are states where they have been covered by the state or the health funds. It is not clear whether a populist decision is not at the expense of the health units, he added.

Before the beginning of the conference “The patient at the center of the system,” dedicated to the priorities in healthcare, the former Director of the Military Medical Academy, now an MP from GERB and chairman of the health committee in the parliament, commented the schedule  set by the Health Minister Petar Moskov and included an electronic health card, the basic package of activities to be undertaken by the Health Fund, and those who would be taking up the health funds, the contracts with hospitals, etc.

This type of schedule should be accepted before the budget. It should be corrected according to the budget possibilities. According to such a schedule timeframes should be set which would be the basis for the conversations with other subjects – the BMA, patients’ organizations. The problem is at the expense of what and whom should the reform take place. The patient is most important, his/her requirements and to what degree the financial resources, which the state could provide, are important to the patient. The patient has to control the funds which come with him/her. There is the question about the effective use of the funds for healthcare and the controlling organ should be the Health Fund. Part of the control functions of the audit and the ministry should be transferred to the NHIF. But this is among the priorities of the health minister.

With regard to the idea of merging hospitals on a regional basis General Tonev said that the problem in this merging is it should not lead to even greater costs for the system.

The electronic health card would allow the Ministry, the Health Fund, and the hospitals themselves to receive direct information flow, which at any time would be able to indicate where the patient is, what has been done and how much it costs. Of course, there is duplication of activities, and they lead to the payment of the same meaningless service. The main problem is the lack of coordination, the question is more organizational, he said.

There is a possibility that the user tax pensioners pay when visiting their GP will stay 1 BGN. The Ministry of Finance intends to not pay GPs the funds with which to cover the difference up to 2.90 BGN as is the regular user fee next year. This was announced by the chairman of the Bulgarian Medical Association, Dr. Tsvetan Raichinov. He also specified that the BMA will withdraw from the signing of the National Framework Agreement, if that happens.

The reduced fee for pensioners visiting a doctor is absolute discrimination against the rest of the population was explicit Raichinov. “By what logic will everyone else pay 2.90 BGN, as if we were of another category. The prior intention of the Ministry of Finance was the fee to remain 1 BGN for pensioners and not to be compensated, which the Medical Association cannot accept. The Ministry has not foreseen the 15 million needed for the payment of this fee in its budget. If this happens, I can guarantee now that there will be no framework contract and the Medical Association will withdraw from the other institutions in the country. This cannot be approached purely mechanically. These are things that doctors do and therefore they cannot be taken from there. If those 15 million BGN would solve the problems of the country – good. Well, there would arise another small problem – no doctors will be left, especially in the rural areas, but I think that this country does not seem to be bothered by this,” – he said.

Doctors will agree to a NHIF budget for the next year which would amount to the same sum as this year’s plus 325 million BGN, said Tsvetan Raichinov after a meeting with the Health Minister Dr. Petar Moskov. “This is a budget that is realistic for the next year, in order there to be predictability and tranquillity in the system. If the budget is less than this year’s plus the two updates, there will be no framework agreement, ” – said the representative of the BMA as well.

Issued on paper forms will no longer be valid

From the beginning of next year doctors will submit electronically medical sick notes in the National Social Security Institute (NSSI) and after December 31, issued hospital paper forms will not be valid. This was announced last week by the Institute. The reason for the change is the operation of an electronic registry of medical sick notes that starts from the 1^st of January 2015.

From the 1^st of December this year the registered in the NSSI medical institutions can receive unique numbers for the medical sick notes from the local offices of the Institute or online via a web application. Doctors and the medical institutions have to be registered as users the of web services provided by the Institute starting the same day, which will facilitate the exchange of data between the system and the electronic register.

The registration is done through a web application accessible through the website of the Institute. For this purpose, doctors, medical institutions and individual practices have to hold a valid certificate for a qualified electronic signature.

The NSSI reminds that the receipt of unique numbers of medical sick notes and making them available to the doctors is the responsibility of the heads of the medical institutions.

The medical institutions, which are not registered in the NSSI, have to submit an application form (together with the registration of the medical institution) from the 1^st of December to obtain unique numbers for the medical sick notes in the territorial division of the NSSI.

For the issuing of medical sick notes after the 1^st of January 2015 it is obligatory to use the software distributed by the NSSI free of charge or any other programs with defined requirements, published on the website of the Institute. They are intended for the software developers used by the medical expertise authorities and the medical institutions.

Beta-blockers are an indispensable element of drug therapy in heart failure (HF). Several multicenter trials have confirmed the beneficial effects of some of them on the survival, hospitalizations, morbidity, and the various clinical aspects of this disease.

The treatment with beta-blockers reduces hospitalizations (total and cardiovascular in HF), improves the functional class and leads to delayed worsening of HF. This benefit has been consistently observed in subgroups of different age, sex, functional class, left ventricular ejection fraction (LVEF), ischemic or non-ischemic etiology (Grade of recommendation I, level of evidence A).

In patients with LV systolic dysfunction, with or without symptomatic heart failure after acute MI, long-term treatment with beta-blockers in addition to ACE inhibition is recommended, in order to reduce mortality (degree of recommendation I, level of evidence B) .

In patients with HF there may be differences in the clinical effect of the different beta-blockers. Four beta-blockers are mainly recommended for the treatment of HF, depending on the case – bisoprolol, carvedilol, metoprolol succinate or nebivolol (degree of recommendation I, level of evidence A).

What are the differences of carvedilol in comparison with the other three?

In addition to beta-1, carvedilol blocks beta 2 and alpha 1-adrenoceptors and has antioxidant properties. Sarvedilol improves the left ventricular ejection fraction in patients with chronic heart failure (CHF).

Moreover, in cases of CHF and left ventricular dysfunction after myocardial infarction (MI), the treatment with carvedilol limits the remodelling of the left ventricle.

The study COPERNICUS- Carvedilol Prospective Randomized Cumulative Survival Study (with 2289 participants) demonstrated that carvedilol significantly reduced mortality and hospitalizations for severe (grade III-IV in NYHA) CHF. Another study – CAPRICORN -Carvedilol Post-Infarction Survival Control in Left Ventricular Dysfunction (1959 patients with LV systolic dysfunction after-MI) demonstrated the beneficial effects of carvedilol in infarction condition – that it reduced mortality.

The particular importance of the antioxidant properties of carvedilol are as follows:

– Reduction of the oxidative stress on cardiomyocytes – a delay of the remodelling of the ventricular wall;

– Reduction of the importance of the “reperfusion syndrome” – in some patients with MI and reperfusion  a fulminant HF is developed afterwards. Sarvedilol limits the “oxygen shock” on the cells;

– Improving the opportunities for the production of nitric oxide.

What is the importance of the alpha-1 blockade induced by carvedilol?

In HF the heart works with a decreased flow, against an increased peripheral vascular resistance.

By blocking the alpha-1-adrenergic receptors in the periphery, carvedilol causes vasodilation, reduces the peripheral vascular resistance and hence decreases the afterload of the heart, therefore, limiting the hypertrophy of the left ventricle and the subsequent diastolic dysfunction.

Hence the additional effect of carvedilol on the development of HF – functional class improvement, and improvement of the quality of life.

Tchaikapharma – High Quality Medicines Inc. produces licensed Dilatrend (carvedilol) and is a Marketing Authorization Holder of the product.

Dilatrend has been in the list of NHIF since the 16^th of November 2014, with the following codes:
Dilatrend 6.25 mg x 28 tabl. – CG 221
Dilatrend 12.5 mg x 28 tabl. – CG 220
Dilatrend 25 mg x 28 tabl. – CG 219

Interview with Nikolay Hadjidonchev, Chairman of the Bulgarian Generic Pharmaceutical Association “BGPharmA”

For two years you are fighting to get a precise breakdown of costs for medicines by the health insurance fund, more precisely this is normal request for transparency. Have the NHIF or the Health Ministry shown will during this period?

There should be some form of transparency, which will allow monitoring of the expenses for the various medicines. The information system of the health insurance fund must allow this to be done electronically, the system should allow transparency of the expenses and this information should be publicly available. We have received so far only data at our request for the expenses for some medicines.

Are you satisfied that the necessity of the pro generic orientation is realized by all political parties?

We are pleased that at least it is included in the election campaign of almost all political parties. Now the question is of the pro generic policy that all use as mantra, to give it meaning and to implement adequately.  What does adequately mean? When you have a pro generic policy, it is not acceptable to have part of the population with chronic diseases to cover most of the costs for the treatment. It is not acceptable, when you are insured and you have high blood pressure or hearth problem, to have to cover most of the costs for the treatment. A base possibility should be provided for free of charge therapy based on generic medicines. Everybody, especially people without income, pensioners should be guaranteed one free of charge package for chronic diseases. From there on everybody has the possibility to pay the surcharge or to purchase other medicines if so wishes. When we are talking of pro generic policy, the main direction we stand for, and the appeal here is to the public – the generic medicines for many years have proven their effectiveness and are means by which all developed countries save and cope with the rising prices. People live longer and the medicines in number of packages increase.

Have you calculated how much this would cost, based on the number of chronically ill?

It is very difficult for us to calculate without adequate information from the fund. So far we have information from IMS. The exact number of the patients is in the database on the NIHF. As an association we have a close standpoint with the Bulgarian Medical Association, but we have to unite with all the participants in the process such as patient societies, the pharmaceutical union, the association of owners of pharmacies and others. Calculations should me made, the legislature should be changed and once and for all we should find a way to guarantee a basic, free of charge package of medicines for the major diseases of every insured patient. The pro generic policy means also to stop partial reforms and short term initiatives and to follow a strategy to ensure adequate healthcare Bulgarian patient. This can be achieved now only if all political forces unite on some main reforms in health care and which will be guaranteed adequate long term financing. Judging from the statements of all the politicians, there are no differences in the basic key guidelines of health care. Now is the time to rally around a cause, the future of the nation depends on solving the demographic problem and healthcare reforms. This is a national salvation. Along with the economic development, which is a key task, answer should be provided to how the health care will be finances, will the health care fund be demonopolized, how the collection of the contributions will be increased, the national health card, the number of hospitals and how the state will provide adequate insurance to people for whom it is responsible. Everything is a matter of vision and political will. And when you have a large number of analogs, it is normal to base treatment of the disease on the basis of generic medicines in order to free resources for those diseases which are treated only with medications without analog. Pro-generic policy does not mean use of only generic medicines. Advanced countries use whenever possible mainly generic medicines in order to free financial resources for expensive original medicines that have no alternative. And why the diseases, the treatment of which is possible with a wide range of generic medicines, should be treated with more expensive original? This decision should be left to the patient in accordance with his/her financial capabilities and under the guidance of a doctor. Today this possibility is usually not provided to the patient. Do not forget that Bulgaria has for years a very strong generic industry. Pharmaceutical manufacturing is the leading sector according to the latest World Bank report, creates gross domestic product, jobs, and pays taxes, insurances. We have potential; the people employed in this sector, 10% of the employed in Europe in the pharmaceutical industry are in Bulgaria. In which other industry we have such allocation? Therefore we should enable it to continue to invest, export from Bulgaria, have adequate regulations, have high quality and here we can look at the changes that are planned related to the Drug Agency, we need professionalism, we need support. The Drug Agency must be open to the problems of Bulgarian generic industry and create normal environment for its development and growth.

Other countries more or less find mechanisms to support the generic industry.

This is a matter of state policy and promoting the local economy and employment with adequate regulations. In the EU some countries such as Slovenia and Hungary have similar practices. Everything again comes to economic vision and political will. We are preparing now a White Paper with medicines that have been withdrawn from the Bulgarian market and the production is discontinued because of impossibility to be sold. When s generic product is withdrawn due to economic reasons and there is no other generic product on the market, only one alternative remains – medicines with patent protection, respectively with much higher price. Thus the expenses for treatment are increasing instead of decreasing. Time and in-depth analysis would show to what extent price referencing really contributed to the reduction of the costs of the state. There is now an unfavorable trend generics to be withdrawn from the Bulgarian market, the moment when companies will be forced to rethink their presence here is not far away. Products are withdrawn which are basic therapy and often do not have a second or third similar generic product.

What is the share of the generic industry in the payments of the Health Insurance Fund?

The total medicine market in Bulgaria, according to the official data from the IMS Health – 259 million packages were sold in 2013 and the distribution between originals and generics is 58 mln. to 201 mln. packages. This in percentage is 22.4% to 77.6%. Compared to the previous 2012, the market growth in the packages is respectively 10% for the originals and 1% for the generics. In value the numbers are as follows: the total market was BGN 2.343 billion, as the 58 mln. packages of originals were BGN 1.228 billion., and for the 201 mln. packages of generic were spent BGN 1.115 billion. In percentage the ratio is 52.4% to 47.6%. The growth in the value of the originals from the previous 2012 was 12% compared to 2% for generics. In the first half of 2014 the value of the originals continued to grow and it seems that the trend of increase of the cost of original medicines, which account for more than half the financial resources of public funds and the amounts paid by the patients, is deepening. How these indicators are placed in the estimates of the NHIF is confidential information, which we do not have. Unfortunately biggest expense of the health insurance fund is for medicines protected by patent, mainly used in oncology, rare diseases and others. For a large group of medicines with expired patent protection the costs are for much more patients and they are primarily for socially significant diseases – hypertension, ischemic heart disease, cerebrovascular disease, diabetes and others. In this large group is the key role of generic medicines, but they are not used enough and rationally. The original medicines in this group of medications with expired patent protection retained above 40% of the market and the low percentage of reimbursement by the Fund for these diseases – 25-50%, the patients pay a lot for their medicines and so at the lowest prices in the EU, to the Bulgarians the medicines seem expensive. There is no policy, neither in the Fund nor in the Ministry of Health, to create conditions for doctors to prescribe mainly generic medicines if the treatment option is available with them. At the same time there were negative campaigns by patient’s organizations and as a result – withdrawal from the market of generic drugs. This happened with the immunosuppressants and the Fund had to pull out additional BNG 1 million to pay the therapy with original medicines. None of us ever spoke of automatic replacement. Everything depends on the doctors and they must it adequately. But when you have for example a new drug that is cheaper, it is normal for the new patients to start with it. Then there will be no problems with the potential risks when changing one drug to another. But when we reject in general generic and biosimilar medicines, this leads to serious concerns, speculation with fears of patients and unsubstantiated comments … ineffective, unclear safety! Nowadays we cannot speculate about their quality in Bulgaria when hundreds of thousands of patients are treated with these drugs in Western Europe.

And at the same time there is not even one signal about the qualities of the medicines to the BDA. So I say that we must think responsibly and the liability is not only of the reimbursement authority or the Ministry of Health, it is also of the doctors and patient associations.

When we talk about pro-generic policy, there are several elements. One of them is clear mechanism of stimulation of generic prescription. But the main figure is patient. He should get quality, efficient, safe, accessible and free medical treatment when insured. Generic medicines make it possible to treat large numbers of patients, and also to the release of funds with which to pay for unique innovative therapies.