The generics make treatment of a larger number of patients possible by releasing funds for innovative therapies without analogue

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.