Replacing medications – why, when and how?

In recent weeks, we have witnessed a heated debate between doctors and master pharmacists about the right and procedure for prescribing medicines for Bulgarian patients. Pharmacists start from the angle that, as a result of the state of emergency, there is a possibility that certain medicines or their analogues will become a scarce commodity. That is why they propose to have the right to replace the therapy prescribed by the doctor at their own discretion. On the other hand, doctors say that the responsibility for treating the patient is theirs, and that such a replacement cannot take place without their knowledge and permission.

Why?

Generic substitution is applied in many European countries and around the world as a measure to optimize public resources, and also to increase patients' access to therapies for chronic, socially significant diseases. Of course, like any other measure in the field of healthcare, it is accompanied by strict rules and restrictions - of a medical and economic nature. For example, the substituted medicinal product must have the same active substance, dosage form and dosage, and be cheaper than the prescribed originator. In many countries, the doctor must be informed in a timely manner about the substitution, and has the right to prohibit it, justifying it medically. For certain medications, generic substitution is limited - such as drugs for the treatment of psychiatric diseases, as well as immunosuppressants for transplants, rare diseases, etc. Other restrictions among European countries concern vertical integration (manufacturer - wholesaler - pharmacy), which creates prerequisites for monopoly or oligopoly of large pharmacy chains and pushing small ones out of the market.

When?

The main question is whether such a legislative change is currently necessary? The only argument for it is that due to the emergency situation in which the world finds itself, there is a danger of a shortage of certain medicinal products from the shelves of pharmacies. On the other hand, however, there is no analysis and assessment of the impact. There is also no information about potential shortages of specific medicines in the pharmacy network. In terms of availability - due to the good coordination between Bulgarian and foreign generic drug manufacturers, there is currently no shortage of medicines in Bulgaria.

Also, with the cooperation of all manufacturers and importers of medicines under the leadership of the Ministry of Health, a system for collecting data on possible problems with the production or supply of medicines was created at the Executive Agency for Medicines. A similar system has been organized at the European Commission, and so far no data on shortages have been announced. The so-called "green corridors" have also been created for the supply of medicines and raw materials for production, which will prevent the emergence of deficits on the Bulgarian market . That is why the arguments for introducing generic substitution are currently exaggerated. Any unmeasured and thoughtless change to the legislation may now be detrimental to both Bulgarian patients and their treating doctors, as well as some pharmacists.

How?

We come to the most important issue in the equation – the conditions and procedure by which the progeneric policy in Bulgaria should be implemented. Healthcare is a system of interconnected vessels, therefore, first of all, there needs to be an agreement between all stakeholders in the process, namely – the professional organizations of doctors, dentists, pharmacists, but also the patients. The second necessary condition, which exists in all countries that have introduced generic substitution , is the availability of an electronic prescription and patient file. The goal is for health funds and institutions to have timely information regarding the availability and prescription of medicines in the network. The electronicization of the system also serves for communication between treating doctors and pharmacists, so that when changing the therapy in one of the two parties, the other will be informed in a timely manner. The third condition is social – minimizing the co-payment by the patient, regarding medicines for socially significant diseases, such as cardiovascular diseases.

In Bulgaria, about 1.5 million patients pay between 60% and 70% for these medications. Countries that have introduced generic substitution have done so with the aim of optimizing their public resources, but also the resources of households, since the costs of treatment for large groups of patients increase annually. The fourth condition is that substitution must always be to the financial benefit, not to the detriment of the patient, namely with a medication at a lower price. The fifth necessary condition is the limitation of vertical integration in order to prevent abuses of a monopoly or oligopoly position on the market, which could lead to an outflow of competition and subsequently an increase in the prices of medications. The sixth necessary condition is the elimination of internal price referencing in relation to medications paid for by the NHIF, which harms competition between different manufacturers and leads to the absence of specific medications from the Bulgarian market.

The decision is not well thought out and discussed.

At the moment, there is no official information from the Executive Agency for Medicines about the lack of specific products from the pharmacy network in Bulgaria. The proposed changes regarding generic drug substitution require an impact assessment and agreement of all stakeholders in the field. Otherwise, their adoption can and will lead to very serious health, economic and political turmoil at a time when society, medical professionals and institutions must be united to combat the threat of COVID-19.

The article was originally published in the newspaper "Trud"

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