What next for prescription medicines? New regulations a threat. Episode 31

27.12.2023
00:38:20

The new reimbursement law could turn the world of Polish pharmacy upside down, especially in the area of prescription medicines. These specially prepared preparations are essential for 3 million patients, including animals, which often require individually tailored therapy. In the latest episode of the programme 'Po pierwsze Pacjent', Monika Rachtan talks to Magdalena Bogucka, President of the Management Board of Zakłady Farmaceutyczne AMARA, about prescription drugs and the negative effects that the new regulations may bring. Do the changes mean the end of access to personalised medicines? What will be the consequences for patients who have benefited from this type of therapy so far?

Prescription medicines

Prescription medicines are individually prepared medical preparations, made in the pharmacy according to the exact instructions of the doctor. They respond to the individual needs of the patient, including their age, gender, co-morbidities and particular reaction to the components of the medicine. These medicines differ from standard ready-made medicines because they are tailored to a person's unique medical requirements.

They are characterised by a simple formulation, e.g. without preservatives, which clearly reduces the risk of allergic reactions, which is particularly important for patients with allergies or intolerances. They can be used in situations where there is a shortage of ready-made medicines on the market or where standard doses and forms of medicines do not meet the patient's needs.

Prescription medicines are particularly important in paediatrics, dermatology and gynaecology, but are also used in other areas of medicine. They are essential for patients who require precisely tailored therapy, especially for rare diseases or specific health conditions.

The benefits of using prescription medicines for patients include:

  • individual adjustment of the dose and form of the medicine,
  • reducing the risk of allergic reactions,
  • the answer to the lack of available ready-made medicines,
  • the possibility of treating rare and specific conditions,
  • flexibility to adapt therapies,
  • optimising treatment,
  • reduction of excipients,
  • treatment options for intolerance to standard forms of the drug.

The new Reimbursement Act and drug prescriptions

The new reimbursement law poses a serious threat to the future of prescription medicines in Poland. The limits on funding per unit of pharmaceutical raw material for these medicines, set by the President of the National Health Fund on 27 November 2023, could make them significantly more expensive and limit availability. Using the example of the drug Dioninum, used in the treatment of cancer pain, we can see that the patient's fee may increase from PLN 18 to a multiple of this amount.

Pharmacy prescribing is extremely important in the treatment of rare diseases that affect a significant proportion of our population. The AMARA Pharmaceutical Plant, as the only Polish manufacturer of raw materials, draws attention to the negative consequences of the new list of limits. These restrictions may lead to shortages of raw materials and inhibit the production of prescription drugs, which are often the only therapy option for patients.

ZF AMARA invests in the development of pharmacy formulations, introducing new substances and grammages. It also cooperates with Polish scientific institutions such as Jagiellonian University and the Cracow University of Technology, supporting the development of personalised medicine. However, the legal changes that are being introduced may inhibit these activities, limiting access to individually tailored medicines and negatively affecting patients with chronic diseases.

Regulatory change and the activities of pharmaceutical companies

The introduction of the new reimbursement law may have serious consequences for manufacturers of prescription drugs in Poland, such as Zakłady Farmaceutyczne Amara. Magdalena Bogucka points out that the price limits set are extremely low and do not cover actual production costs.

- This poses the risk of interrupting the production of prescription drugs, which will directly affect patients, especially those being treated for rare diseases, for whom these drugs are often the only therapeutic option, says Magdalena Bogucka.

The changes to the law could also negatively affect employment and the financial stability of pharmaceutical companies. The guest of the episode stresses that these restrictions not only threaten the continuation of production, but could also lead to company closures and job losses. In the face of these challenges, companies such as AMARA call for a thoughtful and realistic adaptation of price limits to market realities to ensure the continued supply of essential prescription medicines to Polish patients.

The patient's perspective

The introduction of the new reimbursement law is causing concern among patients treated with prescription medicines. These individually tailored medicines are crucial for people struggling with, for example, chronic dermatological conditions or rare diseases, for whom standard ready-made medicines are not suitable or sufficient for treatment. These changes put the health and lives of many patients at risk, especially those who rely on specialised drug formulations on a daily basis.

Patients' concerns focus not only on the potential increase in the price of medicines, but also on the risk of their unavailability. Such changes could have a drastic impact on people struggling with chronic and rare diseases, for whom medicines are an important part of treatment. Additionally, the new regulations could result in the closure of pharmacies and laboratories producing these specialised medications, further limiting access to essential medicines and treatment options for many patients.

In this situation, it is crucial that the Ministry of Health and the National Health Fund focus on the needs of patients and adapt the regulations to the current market situation. It is important to ensure that patients in Poland do not lose access to important treatment options, which would have a significant impact on their health and quality of life.

Use of Prescription Drugs in Veterinary Medicine

Prescription medicines are crucial not only in human treatment, but also in veterinary medicine. Many of the domestic, exotic and wild animals that end up in rehabilitation centres or asylums are treated specifically with prescription drugs. Decisions regarding restrictions on the production of raw materials for these drugs therefore have a direct impact on the health and lives of these animals.

The most common prescription medicines for animals are powders placed in capsules, which are used, for example, to treat epilepsy in dogs. Veterinarians also prescribe eye or ear drops to relieve infections, and ointments for use on the skin. Sometimes these medicines are the only treatment options available for animals, as there is a lack of ready-made products on the market dedicated to their specific needs.

In addition, there are rehabilitation centres for wild animals and asylums for invasive species such as raccoons and suricates. These facilities also use prescription medicines, as the pharmaceutical market does not offer ready-made medicinal preparations for these animals.

The 'Patient First' programme is available on multiple platforms, including Spotify, Apple Podcasts and Google Podcasts.

Transcription

Monika Rachtan
I invite you to listen to the podcast. First of all, the patient. I think every one of you has at some point received a prescription for a made-up ointment. The doctor wrote you down the exact ingredients from which the pharmacist would create the medicine for you. And such a medicine was created, and you picked it up at the pharmacy and paid a few zlotys for it. But what if I told you that for the same medicine you would have to pay perhaps as much as PLN 500 700 in a moment? Why is this happening? Well, that is why. Today I am going to talk about it with Ms Magdalena Bogucka. President of Zakłady Farmaceutyczne Amara. Welcome,

Magdalena Bogucka
A very warm welcome to you. Good morning, Madam Editor, Thank you for the invitation.

Magdalena Bogucka
Well, I have just talked about the fact that these made-up medicines can get very expensive, and it appears that the new reimbursement law may do away with pharmacy prescribing altogether. Why is this happening?

Magdalena Bogucka
Why is this happening? This is a very complex question. However, it is probably best to start at the beginning, and that is with legislation, with legislation. Optical prescription is quite specific, because until now, until the Reimbursement Act came into force, it was only present at a certain stage in a certain system in the reimbursement process, namely only at the point when this medicine was dispensed to the patient. The entire distribution chain, starting with the manufacturer, was not included in the Reimbursement Act. It was not dealt with in the same way as for finished medicines. It was decided to regulate this market, which is always a positive aspect, so that certain things that are not regulated are regulated and each recipient, each addressee is able and can function properly in this market. A consequence of the introduction of the Reimbursement Act with regard to substances for pharmacy prescriptions was that limits were also set for the prices of pharmaceutical raw materials,

Monika Rachtan
These are the raw materials from which the medicine is made. In a pharmacy, just like that, they come into the pharmacy, they are mixed and then in this box they are found in a white box with a card.

Magdalena Bogucka
Yes, and now, as a manufacturer, I can list a number of factors that affect the cost of producing such a raw material for a pharmacy formulation, in the same way as for a finished drug, which we also market. In every field, in every industry, something that is manufactured has its value in terms of labour time, the time of components used in production or the time or, in general, the cost of organising the place where such products can be manufactured. In the case of medicines, these are known to be the very stringent requirements of good manufacturing practice.

Monika Rachtan
And now we will explain in simple terms, and well, because that is what you say, that there are components for the patient. A person comes into a pharmaceutical plant, just as in your case he stands on the production line. There is a need for electricity, right? So that, so that this medicine or these substances can be produced. This man also gets paid, he has to go on holiday, he can go on leave. That's all. And then there's the medicine that has to be packaged in something,

Magdalena Bogucka
examine it in order to market it, to comply with all quality standards. Yes, these are all elements that affect the price of such a raw material. And now comes the list of price limits for pharmaceutical raw materials. It turns out that, for example, one gram of a particular substance is priced at one penny.

Monika Rachtan
So sorry, but the man who works there will not get paid if it costs that much. You will not pay for that electricity either,

Magdalena Bogucka
then we probably won't even buy a package in which we can pack anything, if we have the component, the raw material, to pack it in anything at all. This is some kind of abstraction. Well, now how are we supposed to produce raw materials for pharmacy formulation if the limit set is below any manufacturing cost? Of course, I cannot generalise here, because not all valuations are down to a penny, but the vast majority are priced below any manufacturing cost. So now, on the one hand, the issue of the availability of these raw materials for pharmacy formulation to the patient at all, the fact that it may happen that the patient has to pay such a high amount for the medicine is one but. I believe that the bigger problem is that he or she will not be able to fill the prescription at all, quite apart from its pricing, because the raw material will simply not be there.

Monika Rachtan
This is precisely because it may turn out that companies such as yours will cease to manufacture these raw materials at all, and will abandon this branch of their activity. However, I would also like to ask exactly what a pharmacist's formula is, because in Poland, I have the impression that we slightly underestimate it. However, in the West, this pharmacy formulation is used very often. So if we could explain to our viewers exactly what drugs are, prescription drugs,

Magdalena Bogucka
Yes, unfortunately, there is still an underestimation of prescription medicine in Poland, although I hope and invariably believe in the trend towards personalisation, individualisation of treatment, and that this mega-trend will also be noticed in Poland.

Magdalena Bogucka
This is because a prescription medicine is, on the one hand, a medicine that has no equivalent in a ready-made medicine and, on the other hand, it is a medicine in which we can target an already defined dose of the active substance to the patient's condition, taking into account the patient's age, gender, all co-morbidities, simply targeting a specific medicine for a specific patient individually, specifically for that specific patient, without treating him or her in general at the point where ready-made medicines are used. Another aspect is the allergy issues that more and more patients are facing and dealing with when preparing a prescription medicine. It has a simplified formulation, a negligible amount of excipients, in fact a negligible amount of any preservatives. There are no colourings that can cause such allergies. The prescription drug meets the needs of patients who, for example, have swallowing difficulties by adapting the appropriate form of administration of such a drug. Receptura meets the needs of the patient in terms of his or her illness, but also in terms of various other predispositions.

Monika Rachtan
I'm thinking about the fact that we just underestimate a little bit this possibility that we come, we come to the doctor first and this individualised therapy just for our needs. Yes, we all say that doctors treat in bands. And here we have an example

Magdalena Bogucka
The answer actually to this allegation is that the doctor can create a treatment protocol, also complementary with a ready-made medicine. But this is something that allows you to individualise, to target appropriately under a specific patient.

Monika Rachtan
I also think that such a prescription drug allows us to use the finances, the resources invested in the education of pharmacists, because today, however, the role of the pharmacist. This profession is a bit reduced to a person who sells medicines. But these people are very well educated people.

Magdalena Bogucka
Of course, after all, they have been in education for nearly six years,

Monika Rachtan
have amazing abilities and when there is such a place in a pharmacy, because let's also say that it is a special place that is equipped with special.

Magdalena Bogucka
which are actually equipped with specialised equipment, and the people who make these light formulations have the specific knowledge and skills to prepare this medicine.

Monika Rachtan
Well, that is exactly it. And the moment we take away this possibility of preparing these medicines, these prescriptions, it is not we, but the National Health Fund and the Ministry of Health which will take away this possibility. This will be to the detriment, first and foremost, of patients, to the detriment of companies such as yours, which allow these medicines, these recipes, to be prepared in pharmacies, but also to pharmacies themselves, because pharmacists will simply not have these medicines.

Magdalena Bogucka
I definitely agree. On the one hand, pharmacy professionals who make medicines, prescription medicines, who, when providing pharmaceutical care services, can also use prescription treatment here, because it is concretised for the patient in question, but above all this patient at the end of the day. What about patients who have problems? Maybe let's talk about examples with psoriasis, where there is no ready-made medicine in which the active ingredient is X in the morning? If we are to make an ethanol ointment it is only in a pharmacy formulation, because this raw material for a pharmacy formulation imported by us, for example. What about substances that are not introduced by anyone other than a measure such as EU, which is a morphine derivative used in pain management?

Monika Rachtan
We are not talking here about the conditions of some pimples, but these are serious chronic conditions.

Magdalena Bogucka
Of course they do. What about the small patients lying in the wards ontologies who have heart problems? There, too, only very low-dose powders are used to cure small hearts. What about children who are just being born? After all, every little kid has their eyes sprinkled with ointment or silver nitrate drops.

Magdalena Bogucka
It is not possible to prepare such drops on an industrial scale because they have a very low shelf life. I really cannot understand this perception and this erroneous narrative that why do we need medicines, formulas, when we have ready-made medicines and can replace them. I must clearly emphasise the fact that a prescription medicine is not a substitute for a ready-made medicine. It complements the treatment protocol and is there where the ready-made medicine is absent.

Monika Rachtan
It is my question whether the Ministry of Health, the National Health Fund does not see these needs that we are talking about, Because you said that the narrative at the moment is that you can nevertheless replace a medicine with a prescription or a ready-made medicine and that all those patients who need such an individual therapy, who need it, can nevertheless come to buy it in a pharmacy. All this time it's ointment in a tube and that nothing bad will happen. What is going on in this narrative?

Magdalena Bogucka
Me honestly. I've been trying to understand this for a while still and I haven't been able to figure it out, but maybe there's just been a lack of substantive dialogue with the pharmacist and with the doctors, with the patients who are using these drugs and why they're using these drugs.

Magdalena Bogucka
I understand. I also thought about this when you were talking about those examples where medicines and recipes are used, and it is not just the pharmacy we know, the one we go to, but medicines and recipes are, above all, prepared in hospital pharmacies. These are, above all, the examples of paediatric pharmacies which I have mentioned, these are mainly hospital pharmacies, although, on the one hand, hospital pharmacies, where, I should point out, we do not yet have the subject of reimbursement of raw materials for pharmacy prescriptions, and it also looks analogous. The manufacturer supplies substances for the prescription both to hospital pharmacies and to pharmacies open to the public, while the whole process of reimbursement already during the procedure looks completely different. It also seems to me that the Ministry of Health has focused more on the value of the reimbursement in a given year. It only pointed out that the reimbursement of substances for pharmacy prescription is no more than 4% of the total reimbursement budget, because on an annual basis it is also a virtually negligible value. However, it would be worth looking at the welfare of the patient and not necessarily just the value of this reimbursement. Because if there is such a low value of reimbursement, it means that there is a need and there is a significant use of medicines, prescriptions and prescribing of these medicines to patients.

Monika Rachtan
I will ask you this, because I know that our conversation is not your first step in this dialogue with the National Health Fund, with the Ministry of Health, but you have already been having these discussions for many months. When? When?

Magdalena Bogucka
Two hours before the meeting? There was an auto-amendment to the reimbursement law that she introduced. At the time, it still proposed to introduce limits for the price of pharmaceutical raw materials,

Monika Rachtan
But Generally in this whole draft, in these publications of the Ministry of Health, of the National Health Fund. There are very many mistakes in this bill, which you also point out. And in fact, when we were reviewing this document together, it's. I have a bit of a feeling that it was written by some sorry child. There are so many factual errors in there that it couldn't have been prepared by a person who knows what he's talking about, knows about. anything about prescribing.

Magdalena Bogucka
I really don't know how to explain it. Maybe it is a matter of haste, maybe not having verified all the data, maybe a lack of such a skilful approach, interpretation of the facts. It is really difficult for me to comment on this, but I do have faith in the dialogue, in the substantive dialogue, and in the fact that it will still be possible to take steps to regulate the situation of raw materials for pharmacy prescriptions, on the one hand, and to eliminate abuses, if any, on the other, and, thirdly and most importantly, to make medicines and prescriptions available to patients.

Monika Rachtan
All right, but let's get back to what is currently happening in terms of this situation, because it is December. We have a new Minister of Health who, as she promised, is going to deal with all these issues that are important for patients. We can see that she has been acting vigorously for a few days now. And now the question is what do you expect from the Ministry of Health? What changes and what dialogue? Because we know that this matter related to the law has been going on for several months. De facto today, a patient who goes to a pharmacy for a prescription medicine will pay

Magdalena Bogucka
us still 18 from January 20.10 but may have to pay a surcharge on this prescription due to the higher price. Raw materials for pharmacy prescriptions exceeding the list value

Monika Rachtan
Your substances in pharmacies. It won't. I understand in January, if this law is not amended, if these limits are not fixed. Simply after the publication of the list of raw material prices, the formulation was not forced to stop production either. At this point, we are not producing substances for pharmacy formulation. The fact is that many of these substances are in our warehouse, because the process of manufacturing substances for pharmacy formulation is very time-consuming.

Magdalena Bogucka
So I can't say that from January onwards these substances won't be there, because we still have some stock. But given that we have been out of this production for a fortnight now, it is clear that this stock will run out at some point. I don't know how we are supposed to produce something that is priced at 1 penny per gram of a substance.

Monika Rachtan
OK, then I'll still ask about whether the Amara Pharmaceutical Plant might close over time because of these limits that have come up?

Magdalena Bogucka
The limits are set on the basis of 2022 data. They are supposed to be in force and apply to the economic and economic situation in 2024. So this jump of two years, where we know what the economic situation is, what level of inflation we have, how costs are rising, how workers' salaries are rising, is a rather risky assumption. That is one side of it, and the other side of it is also that these limits would have to be adjusted to the current economic situation. This is probably what I expect the most, and what I hope for the most is that the Ministry of Health will look into this so that there will be continuity of production.

Magdalena Bogucka
It is really difficult for me to talk about stories that have such a huge impact on the plant I manage, which as recently as July employed nearly 350 people, which pays PLN 28 million in taxes to the state budget every year. When I have to put a significant part of my organisation on hold, it's hardly cause for optimism. And for this reason I am also in such a dilemma that on the one hand it is. This is three million patients, because so many patients are treated with medicines, with new prescriptions, but on the other hand, this is also nearly half a thousand families who are alive and who. Whose households are supported as a result of the wages taken from the company they work for today.

Monika Rachtan
Well, this is a very important problem, because, of course, we are talking here about patients, we are in the patient first programme, so it is the good of the patient that is most important to us. But, on the other hand, such decisions by the Ministry of Health, and this does not only concern your company Ambra, your pharmaceutical plants, because there are more companies in Poland which produce these raw materials. You are not the only ones, and now the fate of people who work, who have just been paying taxes for many years, is at stake. And where is the dialogue, Because we are again at such a point that we are waiting a little bit for the decisions of the new minister. We can talk a little bit about the decisions of the former minister or deputy minister, we can talk about the decisions of the health committee that were made, but de facto no one here is taking into account this social situation, the one related precisely to employees, to your company. Did you also mention this in your talks with the Ministry of Health?

Magdalena Bogucka
We definitely mentioned in our discussions with the Ministry, also the economic situation, the economic situation, the factory that I manage, the employees who work there. Of course we did. All the more so, too. On the one hand, the socio-economic problem of the company, and not even just one, because, as you rightly pointed out to the editor, we are not the only entity that puts a substance into a pharmacy formulation, well, on the other hand, those patients too. The scale is huge, but does this move anyone at all? I do not know.

Monika Rachtan
All the time, the new Prime Minister, Donald Tusk, has been stressing that Mrs Leszczyna was chosen as Minister for Health because she was previously in charge of finance, so it seems that she is someone who will be able to take this list of limits, check and consider that something cannot cost one penny if the package costs one penny. And I see it as a great hope that I will enter into discussions with you, because I know that you have already taken the first step towards those discussions.

Magdalena Bogucka
We have definitely submitted a paper version to the Minister. At this point in time, the factual situation related to pharmacy formulation substances. I am invariably counting on this factual dialogue, the opportunity to meet and talk about this complex and important problem from the point of view of economic and financial knowledge. Above all, I am also counting on human kindness, on the one hand, and, on the other, on verification of the data on the basis of which this list was prepared. We talk all the time about reliability.

Monika Rachtan
We talk all the time about talks, about dialogue, about fairness. I know that in those talks that were held with the previous ministry. You were active, you were on the committees, you were on the committees. You took an active part, you sat on committees, you also wrote complaints, letters, requests. It's not like we woke up the day before you had to stop production and you say But Minister, all that has been done is wrong. What has happened? Could you talk about the process? What did it even look like? What discussions did they participate in? What was promised to you? Not to you, because the patients were promised. And what happened?

Magdalena Bogucka
First of all, from the day this auto-amendment to the Reimbursement Act appeared, the first thing we did was to obtain data from the National Health Fund. What is the basis on which these limits will be calculated, and what is the specific calculation already made in order to be prepared to operate within this new framework? I was taking into account the fact that I might in some way have to remodel production or change the grammages of raw materials to be sold. Although I would still invariably argue that small grammages are a more appropriate way to package substances for pharmacy formulation due to the reduced risk of contemplating these substances. So So So first and foremost, we wanted to know the system in general calculation. We wrote letters, we came to the National Health Fund, we spoke to the Ministry, asking for such data to be made available to us. The data were not made available to us. By explaining that we have no public interest in such data being made available, I will only point out that, on the basis of this data, we wanted to adjust to the possibilities, to the possibility of manufacturing the substance, to the receptor, with which three million patients in Poland are treated. However, it seems that this public interest is quite important. It has not been. Our requests have been heard. To this day, we have not received information on how this list was prepared. However, as a result of its publication, erroneously, as according to the wording of the Act, it should also be published obligatorily in the Public Information Bulletin of the National Health Fund. They sent a letter with a number of objections to this list itself, to the way it was prepared, to the repetition of the included synonyms of 136 items, eight of which are repeated. Substances listed, many of which are not on sale from 2019, substances not on the list at all. Also, a number of allegations we applied to the National Health Fund, hoping that someone would take another look at the archived data and look at it honestly so that this list would simply be relevant to reality. At the moment we have not received any response, so we are stuck at this point of suspension. In fact, we are all even at a point of suspension, because actually this list has not been published in accordance with the law. So maybe if it has not been, then maybe it is not functioning, there is not so much doubt anymore. That it is really difficult for me to talk about it at all and to find a solution to adapt to this situation. On the one hand there is a list inadequately prepared, not reflecting the economic and economic situation at all. On the third hand, it is published in a way that does not adapt to the wording of the provision of the law that provides for it. Also, ambaras and total chaos in this situation. It is just a pity that in all this ambaras, it was just going at the end of the day. There is a patient who will either not be able to fill this prescription or will fill it at some abstract cost.

Monika Rachtan
Well. We were talking earlier about such a problem for patients that. I have the impression that the majority do not expect this at all, that they will go to the pharmacy with the new year and want to buy the prescription medicine that they have been using so far. Because let's remember that these drugs are used for chronic illnesses. Patients go to the pharmacy every month. And now the patient hears at the window that this medicine costs PLN 657. I'm shooting that because he has to pay the difference, if of course the medicine will be available, but we assume it will be, because they still have pharmacies, these stocks. And now what happens? The pharmacist reports. In my opinion, most patients won't have the courage to do that simply, but they will also be surprised. It's not even about courage, but the moment I come to my lady pharmacist, whom I have known for years, whom I talk to about my problems, about my various illnesses, whom I advise and she suddenly tells me. Mrs Monica, £657. You ask, most will answer yes. And then she won't come back for this medicine. The patient loses, but the pharmacy also loses. Because what about these medicines? Who will pay for them if this surcharge is out of the patient's wallet and this reimbursement is so low?

Magdalena Bogucka
This is frightening. And in my opinion, it is even more frightening if a patient comes in and wants to fill a prescription, but with a prescription. And even leaving aside the amount of manufacture of that medicine, he just won't get it. And, for example, he is being treated for a rare genetic disease. His only possible treatment protocol is related to a pharmacy prescription substance, over which Phosphor loses the bases and there is simply no way of any other cure.

Monika Rachtan
I keep wondering what the Ministry of Health had, because we do not talk much about the Ministry that was in mind when creating such provisions of the reimbursement law, but also not listening to these appeals and requests of yours, because the situation of patients. When we look, for example, at the reimbursement list, at the draft reimbursement list from January of this January 2024, which was still being created by the Ministry of Health, the Ministry of Health at that time, it seems that here the good of the patient is very much fought for, because even in rare diseases, such as thyroid cancer, where the therapy is for perhaps only 40 patients a year dedicated, this reimbursement appeared, and here we certainly have a large group of patients who use the medicines, the prescriptions, and these needs of theirs were not noticed

Magdalena Bogucka
Rare diseases affect approximately 7% of the population, that is, roughly 350 million according to 2016 data. Rare diseases are characterised by the fact that they occur, as the name suggests, rarely. Also, it may simply be that someone has missed the fact that there are other rare diseases besides thyroid cancer. And there are another handful. A small negligible number of patients who suffer from such diseases and for whom, again, the treatment is the substance.

Magdalena Bogucka
Treatment can be helped by a pharmacy formulation substance. It is important to consider that not all medicines are cost-effective to produce on a large scale. In the pharmaceutical industry, these are not high-volume quantities, such as a few packs of a particular drug for a patient with a rare disease. We have always kept such patients in mind when introducing a substance into a pharmacy formulation and have often produced a small quantity of literally a few kilos divided into appropriate packages of the raw material, disposal or the vast majority of it just so that a few such packages of the raw material for a pharmacy formulation could be distributed to patients. We have also received such enquiries from the Drug Policy Department of the Ministry of Health on more than one occasion, have you been working at a good level? If we have been receiving enquiries about when a particular raw material will appear, it means that someone has noticed that there is a patient who can only be cured with this raw material. Also, I don't know why it has now been forgotten.

Monika Rachtan
I would like to put this question to the Ministry of Health, maybe I can talk to them in some way. But I would still like to ask about the measure and about this future of yours. Because I also know that you don't only deal with raw materials, but you also have many other medicinal products in your portfolio. Could we perhaps talk about these products? In addition to raw materials, what is produced in pharmaceutical plants? In addition to raw materials for pharmacy formulation, we market medicinal products, primarily spirits, tinctures, syrups.

Magdalena Bogucka
Virtually every patient drinks trace syrup during a cold. My daughter very much is, for example, a syrup that comes out of our factory. In addition to such basic medicinal products, mainly herbal products, which we introduce to pharmacies, there are also probiotics, probiotics under the Tri Lek brand. Because we invariably believe in the trend of individualisation and personalisation of treatment and this elementary supplement. That's where we got the idea for probiotics, which are also a phenomenal idea for treatment and support in many patient conditions. And going from raw materials to pharmacy formulations in the context of, for example, dermatological conditions, we have created a brand of specialised, dermatological, cosmetics under the Amadem brand.

Monika Rachtan
And I can see that these patients' needs are such a guiding, guiding thought in your actions. And I think to myself that the fact that you are here with us today talking about these issues is not only a concern for your own company, for your own employees, but it is first and foremost a concern for patients.

Magdalena Bogucka
Because you keep pointing out that what is going to happen to that patient who comes into the pharmacy and doesn't get it. That medicine. Well, exactly why should this patient come first for the Ministry of Health, for the National Health Fund? Why is it so important to take another look at these regulations and to. Adjust them so that it is the patient who benefits first and foremost. Editor, everyone has a motivator. My motivation is to support doctors and pharmacists in creating treatment protocols for the patient. Health is one of the highest values of every human being. Therefore, we and all those who have any influence on supporting this health of the patient should do everything they can, what they can, what they influence, to support this health. I, for my part, am preparing in my mind with my team. Products that can complement therapy, that can target the wellbeing of this patient, because this patient comes first. I believe that for the institutions, for the state, health, which is emphasised in all normative acts and even in the Constitution, is such an important element of functioning in society, that it will find recognition and that the patient will be able to be treated not only with these substances for pharmacy prescriptions, but in general, it will be an important concern.

Monika Rachtan
We are in the programme patient first, but we are also all patients. Are you? Because I know that you are very active when it comes to patients, that you have contact with patients, that you create a lot of training for pharmacists. Are these voices that are from outside, not only from your staff, not only from you, reaching you as well? Do you see that there is already such a concern emerging that these medicines, the prescriptions, could run out in a moment?

Magdalena Bogucka
Unfortunately, yes. And this is another element of my current functioning that also sort of overwhelms me. On the one hand, there is the vision that, in Poland, pharmacy formulation should come at least a little bit closer to what pharmacy formulation looks like in the United States. It is wonderfully developed, supplemented, new substances are constantly being introduced into pharmacy formulation. And this innovation in medicine, about which there is so much talk, actually finds use there, while with us it is quite the opposite.

Monika Rachtan
I would also like to ask you about medicines, prescriptions, because we all hope that they will not disappear and that they will be available to patients. You said that this is only a few percent of all the medicines that are prescribed in our country. Why is it that this prescription is not being developed in Poland? Is it the fault of the Ministry of Health? Is it the fault of the National Health Fund? It is the fault of doctors, pharmacists and patients.

Magdalena Bogucka
Surely it is a question of patient awareness. Does the patient know that he can ask for the doctor to prescribe a medicine made especially for him? Does he have this awareness that he can get a prescription for a medicine, a prescription, for a medicine, individualised for this particular patient? And, on the other hand, it is not easy to introduce substances into pharmacy prescriptions in Poland, also because of the legislation. It is a very long process to obtain such a marketing authorisation, which is the same as obtaining a marketing authorisation for a medicinal product, i.e. the same path for preparing the registration dossier, for example for a syrup, as for a substance for a pharmacy prescription. This is made very difficult. The dossier itself is complex, expensive and this certainly does not make it any easier either. I think that it is these procedures, these complexities, these waiting times resulting from the law on the one hand, and on the other hand, as in administrative proceedings, which are perpetually extended for some reason.Also, this legislation does not help.

Monika Rachtan
It would be so good if indeed all this were simplified. But above all, this appeal to the new Minister of Health that we are coming with today. I know that you also sent a letter to the new Minister a few days ago, and perhaps if the Minister happens to be listening to us, or perhaps a colleague, what is in that letter? However, if it had got lost, it is certainly in the pile of papers that it is now going to the Minister, because all these problems have to be solved.

Magdalena Bogucka
I sincerely hope that it does not get lost and that this matter will be as important to the Minister as it is to me. And given the sensitive nature of the whole thing and the functioning of three million patients. The letter sets out the facts relating to substances for pharmacy formulae and explains where the cost of raw materials for pharmacy formulae comes from, as well as the advantages of using treatments with substances for pharmacy formulae.

Monika Rachtan
So we have this appeal to you. To the Minister, And I also thought that when we are talking about patients, it is worth mentioning. The quadrupeds that are closest to us, that are in our homes, but are also in other places. I mean animals, that medicines, formulas are also medicines that are just dedicated broadly to veterinary medicine. Of course they are.

Monika Rachtan
I understand that if you stop producing raw materials, that includes for animals. These are the same raw materials with which we treat people and treat animals, So if there are no raw materials, then in the same way there will be no possibility to treat and pets or exotic animals. I understand. So it turns out that these decisions affect not only patients, not only pharmacists, but also our friends, the animals. So I will again appeal to the Minister to deal with this matter as soon as possible. I would like to ask one more question, which we have not discussed, but I think is very important in the context of our discussion today. My programme partner is the Institute for Patients' Rights and Health Education, which talks a great deal about the humanisation of medicine. As a human being, but also as someone who manages a very large company, what is this humanisation for you?

Magdalena Bogucka
Humanising medicine The first association of patient patient, patient welfare, patient at the centre is, in my view, humanising everything around the patient. I recently spoke to the president of the Association for the Personalisation of Treatment Strategies, who just talked beautifully about the topic. The patient is the centres of humanisation, which is the patient at the centre and how the wellbeing of the patient should be as the most important element. And next to that located pharmacist, pharmacy, hospital, doctor. The pharmaceutical industry in the distance. But all these people should be complementary, complementary precisely for the sake of the patient, who should be at the centre and should be treated as such by everyone.

Monika Rachtan
Well, that patient. Centrism is such a strong trend right now. There is a lot of talk about it, a lot of decision-makers talk about it, but I would like it to be not only on the lips of decision-makers, but also in the hearts. And that is what we are all fighting for. Also with this conversation. Definitely like the patient at the centre. It all starts with him. Ladies and gentlemen, thank you very much for your attention. I thank you very much for our conversation today. Thank you also.

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