Czech penicillin? There are three possibilities where he could go off the lines

Patients ran from pharmacy to pharmacy quite often last year. There were no medicines, but mainly the lack of penicillin was addressed. This year, however, a similar situation should not be repeated.

“Today, we physically have supplies here in boxes until the end of September,” says Jiří Volf, director of BB Pharma, which imports penicillin to the Czech Republic.

The company also recently signed a memorandum of cooperation with the Ministry of Health. Among other things, a project is being prepared for a penicillin factory in the Czech Republic, where the tablets would be packaged. In an interview for Seznam Správy, Volf describes the details.

The last time we talked, you said that you hoped that by the beginning of the year “penicillin would be out of the media”…

I was putting a bit of cotton wool on myself because I was confident that it would be done by November, but something can always happen in that chain.

But it worked, didn’t it? Because penicillin, unlike other drugs, really fell out of the media.

Except for the List. I’ll dig a little. Strangely enough, even at work sometimes I can read. Your colleague in an interview with the CEO Dr. Max wrote three or four weeks ago that he had trouble getting penicillin at two pharmacies and was only lucky at the third. Others may get over it, but I jumped because there was and is really enough penicillin.

To date, we have over 90,000 packs of penicillin in stock, and another is on the way, because it’s not worth keeping half a million in stock again. If they don’t have penicillin somewhere, then the fault lies elsewhere.

And can it be expected to be like this in autumn and winter? That the situation from last year, when there really was no penicillin, will not be repeated?

It was not an active substance then. Everything can be replaced, but if the active substance drops out worldwide, you can’t do anything about it. Of course, it can be produced again, but we are talking about the medium or long term. Today, we have the active substance, the packaging material and production capacity are also secured. Today, the only thing that threatens us is a plane falling into production or into storage.

Penicillin just will. With today’s consumption, which is around 10,000 packs per republic, we already have supplies here physically in boxes until the end of September. In addition, the competition will also bring something here. For this, we have an active substance that “just” needs to be processed and then packaged to be imported to the Czech Republic.

And is it possible to increase production if needed?

We are ready for it today. We will not need some ten to 12 months like last year, but we will talk about a month or a month and a half at the most. We also have this time covered in stock.

Is this the reason why the price of penicillin was also increasing?

Yes, these costs must also be included. We pay for everything in advance, from the active substance to raw materials to packaging material and energy. We can’t want a Mercedes when we only have money for a Trabant.

How far is the registration of syrup antibiotic for children? Because the Ministry of Health also talked about it. There were also problems with deliveries last year.

We are currently developing it. The biggest problem is finding a supplier of excipients. We should have a recipe, but according to the pharmacopoeia, many of those substances may no longer be used. So we are inventing a new one and hope to produce stable batches within this year. It then takes six months before we get the initial results, with which we can then proceed to registration. So we are working on it, but we are not able to say when it will be.

Unfortunately, we are not the owner of the registration. If the competition provided it to us, we could start production within a year.

And did you discuss this with anyone?

I don’t want to comment too much on it, because it is a meeting between two private entities. But we approached an unnamed company, we told ourselves what we needed. But they didn’t get back to us, we were just discussing it at the board of directors.

Today, we already arrange Czech batches of medicines for some manufacturers, because it is not worth it for them to deliver to small countries like us. This is how we expand the amount of our medicines. Specifically for penicillin, we want to propose that we invest in a production line, either in the Czech Republic, Slovakia, or a combination, and we will make small batches for other countries as well. That is, for example, the Czech Republic, Hungary, Austria, Slovenia or the Benelux countries.

Every country can do it on its own, but it is not economically worthwhile. But it depends on the agreement at the European level. Unfortunately, they are looking for reasons why it is not possible.

So in the Czech Republic, are we talking about the possibility of a penicillin packaging line?

Thanks to the fact that we have production capacity in Slovakia, we are also able to tablet it there. In the Czech Republic, we can help ourselves by blistering here (tablet packaging, editor’s note).

So does it matter if an investment incentive will be sanctified from the European level?

We said under what economic conditions it is realistic for us. But such an agreement is beyond the possibilities of the Czech government, because it already hits the limits of economic competition. We calculated that the return on investment is about 48 years, and of course no private entity can go into that.

Is it already clear where such a line could be located in the Czech Republic?

Since it has not yet been decided, we have three options worked out. And it depends on what will be the most advantageous in the end, for example in terms of approval speed.

And how big an investment are we talking about?

It depends on what it ends up being. But let’s say that we are talking about 120 to 150 million crowns.

What the Ministry of Health says

Would it make sense not only to package penicillin in the Czech Republic, but also to produce tablets?

We also discussed this with the Ministry of Health, but since everything from granulation to final packaging is approved in Slovakia, it makes no sense to invest like this 400 kilometers apart. In the Czech Republic, we can help ourselves with that packaging.

How do you evaluate the amendment to the Medicines Act, which, according to the Ministry of Health, should also help prevent drug shortages?

I am not sure that in practice it will be possible to eliminate everything that is written about in the amendment.

Some pharmaceutical companies criticize precisely the part that they should be obliged to keep stocks of medicines.

Of course, there are some penalties, but the problem is when you find out that the drug may be in danger of being discontinued. For example – we have one antibiotic that for a long time was the only one that didn’t have an outage, but now it has also happened. And why?

We knew we had supplies until May. We therefore ordered the active substance for March, but at the end of March we received a letter from the supplier saying that the delivery would be delayed by four months. And we were making sure that it would arrive 14 days before. When you find out like this day by day, how can you stock up?

So isn’t there a risk that due to stricter legislation, suppliers will cancel the registration of some medicines?

This is something that we also criticized. I cannot imagine how the Czech Ministry of Health wants to convince the Portuguese manufacturer of anything. He just throws the registration off the table because the two thousand packs sold aren’t worth him risking a fine.

But it will be a problem for patients.

Of course it is. In addition, I see a second risk for a smaller market like ours, which has already hit us. We had one hormonal drug and used approximately 500 grams of the active substance per year. But after supply chains were disrupted during covid, it was said that Asia could not be relied upon.

But the European company told us that the minimum purchase is ten kilos, which for us would be for 20 years, but the expiration is in three years. In addition, they charged us a fee for each registration. So we canceled the registration. Small countries can therefore have a problem getting access to medicines, because it is simply not worth producing for them.