Is our drug policy economically effective?

What is the problem with medications?

The problems in Bulgarian healthcare are not only with medicines. The problem of the entire system is actually the inefficient spending of funds, which is getting worse every year. The second problem is that since the establishment of the National Health Insurance Fund (NHIF) until today, its budget has been growing by an average of about 7% per year, and since 2009 it has grown by 40%.

In the area of medicines, the situation is no different. Many lobbying interests are involved in it, as well as in the overall state of the health fund. Since 2009, the NHIF budget for medicines has increased by approximately 70%. There are many interests behind this - recently, a publication appeared in the media about the financing of conferences of medical experts by large pharmaceutical concerns, which can be traced to certain changes in the positive drug list, as well as in the prescription of certain medications without a prescription.

The problems in healthcare systems, both in Bulgaria and around the world, are that healthcare costs are constantly growing and will continue to grow in the future due to demographic changes and advances in medicine– the increase in life expectancy and the chronicization of some diseases that until recently were rapidly fatal. The problem with medicines in Bulgaria is that public resources for them are not spent optimally – the percentage of co-payment by the patient is one of the highest in the European Union – 60-65%, which is why access is also reduced. The National Health Insurance Fund pays for expensive originals, instead of paying for equivalent generics with the most competitive price. Doctors rarely inform their patients about existing alternatives to their treatment.

What are generics?

When an original medicine is invented, standard patent protection in the EU lasts for 20 years, although the pharmaceutical sector is unique in that this protection can be extended by a Supplementary Protection Certificate (SPC). It aims to compensate manufacturers for the period between the filing of a patent application for a new medicine and its marketing authorisation. Generic medicines can only be made available to patients in the EU after the relevant patents and SPCs for the original product have expired.

After the patent expires, the generic industry has the right to start producing a generic drug. The generic drug itself contains the same active substance (molecule) as the original, and also has the same therapeutic properties, as well as interchangeability with the original. The only things that should differ are the shape, color and name of the original drug. The difference between the original and the generic in economic terms is that the generic is cheaper, but it is just as good. In Bulgaria, the quality of drugs is guaranteed by the Bulgarian Medicines Agency (BDA).

Generics are important for several main reasons:

One of the major problems that the European Commission (EC) highlighted in its latest report on Bulgaria was access to healthcare. The access we are talking about does not only concern physical access to medical care, but also to medicines, which includes several points:

The co-payment percentage– In Bulgaria, the co-payment percentage in the field of medicines is between 55% and 60%. This is the highest co-payment percentage in the EU, where the average co-payment level is around 18-19%. That is why there is a deep-rooted feeling among many of the population that medicines in Bulgaria are expensive. In practice, this is not the case, they are actually the cheapest in Europe, we just pay much more for them. Even if the co-payment percentage remains the same, we can agree that there is a difference in paying 5 leva for a generic and 15 leva for an original medicine.

Awareness– The awareness of patients in Bulgaria is minimal when it comes to their treatment. In the field of medicines, their awareness is also one of the lowest in the EU, and hence one of the main problems. Since certain medical specialists in Bulgaria prefer to prescribe certain medicines (in many cases these medicines are originals), they rarely consult the patient's needs, and also rarely take into account the NHIF budget when doing so. One of the main problems in this area is that doctors do not inform their patients about cheaper and more effective methods of treatment, as well as cheaper therapies. There is nothing wrong with the doctor choosing a therapy at his own expert discretion, the problem is when this therapy is paid for with public funds, and there is also an equivalent and cheaper alternative.

Myths and facts about generic drugs:

Myth 1: Switching from brand-name to generic drugs can worsen a patient's health. Generic drugs have more side effects than brand-name drugs.

Fact: Any type of drug can potentially cause side effects, whether it is an original or a generic. The occurrence of such side effects depends on the clinical condition and predisposition of the patient, his allergic reactions to certain substances in the drug. The brand of the drug is not relevant in this case.

Myth 2: Generic drugs are cheaper because they are inferior versions of brand-name drugs.

Fact: Generic drugs are just as effective as their original “cousins”. The difference in price has nothing to do with the active ingredients used. When producing original drugs, pharmaceutical companies invest in marketing, advertising, research and development, which have a strong impact on the price.

Myth 3: Original drugs are safer than generics.

Fact: Both brand-name and generic drugs use the same set of active ingredients, with the preservatives and flavorings used being the only differences in the composition. Generic drugs are safe. The BDA would not allow unsafe drugs to be sold to the general public.

Myth 4: Generic drugs are poor copies of the original medications, which is why they appear on the market later.

Fact: This is far from the truth. Original drugs appear in pharmacies earlier because their development is funded by drug manufacturers who hold the patent. After the patent expires, generic drugs can be manufactured and then released into pharmacies. As stated above, the same active ingredients and the same manufacturing process are used. The strength and effectiveness of both original and generic drugs are identical.

Myth 5: Doctors prescribe brand-name drugs, therefore they are more effective.

Fact: While it's true that doctors often prescribe brand-name medications, that doesn't mean generic drugs are less effective. In fact, patients can ask their doctors if the prescribed medication has alternatives.

Who is against it and why?

It is difficult to generalize groups that are against, but we can say that certain interests may be affected by changing legislation in favor of economic efficiency.

It is a public secret that doctors are courted by one or another pharmaceutical company in order to prescribe its product to their patients. This is not wrong in itself, because the doctor still has the right to choose what therapy to schedule for his patients. The problem arises when he prescribes medications paid for by the National Health Insurance Fund, for which there are cheap generic alternatives, while failing to explain this to his patients. That is why we have cases of people of retirement age who share in interviews that medications for one disease or another are expensive. In reality, they pay extra for the expensive original that their doctor prescribed.

Others who may be against it are the representatives of patient organizations, whose main goal (and should not be) is to lobby for the inclusion of certain medications in the positive drug list (PLS) in order to be partially or fully paid for by the state. Here we must emphasize very strongly that patient organizations in themselves are not a bad thing, on the contrary, they should be the feedback from patients to doctors and the state on certain pressing problems, but in Bulgaria we rarely see quality feedback from them when it comes to patient rights, access, care and good practices.

How will it help people?

By optimizing drug costs and switching to a progeneric drug policy , the cost of treatment will be significantly reduced. As a result of this policy, economies of scale will be achieved or the cost of medications will decrease with each additional unit of drug produced. The money that patients pay extra for drugs, if generic equivalents exist on the market, will be many times less. Access to drugs will increase and fewer people will drop out of the system due to financial reasons. When dropping out of treatment therapy, the risk of negative health consequences increases for many patients, and sometimes even leads to a fatal outcome.

How will it relieve the healthcare system?

It is a fact that healthcare costs are constantly increasing worldwide. From 1995 to 2014, healthcare costs as a percentage of global GDP increased from 8.5% to 10%. The factors behind this are the progress of medicine, which has led to an increase in the average age of mortality, and the discoveries in the field of innovative medicines, which allow some diseases, until recently considered a death sentence, such as Hepatitis, AIDS, etc., to be controlled and turned into chronic ones.

Taking into account all the above factors and the current situation in Bulgaria, the most sensible move is to optimize healthcare costs - where they can, without negatively affecting patients.

The solution is clear – pro-generic policy has proven its effectiveness in Europe and around the world. The countries in Europe where it is implemented effectively are Germany, the Netherlands and the United Kingdom.

Generic medicines save around 100 billion euros per year for healthcare systems in the European Union, having doubled access to medicines in the last 10 years. The treatment of socially significant diseases such as hypertension and diabetes has become easier and more cost-effective. A pro-generic policy means better access at a lower price and guarantees a long duration of treatment with minimal risk of drop-out due to financial factors.

This article was originally published on OFFNews.

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