WARSAW, 15 Mar (APM) - National Revenue Administration (KAS) will continue fighting drug exporting mafias in Poland after its early successes, reported Dziennik Gazeta Prawna (pB4) on Wednesday.
In an interview with Dziennik Gazeta Prawna on the problem of the drug exporting mafias in Poland, Piotr Walczak from KAS said the pharma market is extremely attractive to criminals as the potential profits from exporting certain medicines are very high, while the risk of getting caught is lower than in the case of distributing narcotics.
He added that organised crime is involved in the pharma market, worth 35 billion zlotys (€8.1 billion), while the value of drugs exported each year could be as high as 2 billion zlotys (€465 million).
While Walczak admits the complete eradication of illegal drug exports is unrealistic, the tightening of the drug distribution supervision system, the provision of additional tools to the KAS and the introduction of more restrictive regulations have resulted in a 40% decline in revenues of pharma wholesalers since June 2018.
Walczak said the KAS will continue to help the Chief Pharmaceutical Inspectorate track and deal with individuals and organisations involved in illegal drug exporting activities. He believes the most effective way of dealing with the issue is prevention and clearly defined, severe penalties that can be swiftly executed by the institutions that have all the tools required for this at their disposal.
Patients with Crohn’s disease have limited access to drugs
Access to modern drugs that could be used for treating Crohn’s disease instead of invasive surgery is restricted, reported Rzeczpospolita (pA11) on Tuesday.
Maria Klopocka from Collegium Medicum in Bydgoszcz said the standard therapy with steroids and immunosuppressants is not always sufficient, in which case infliximab and adalimumab, which are available through drug programmes, are administered to patients.
Unfortunately, patients not responding or no longer responding to this treatment are only left with the option of surgical procedures. Klopocka said such drugs as ustekinumab and vedolizumab are already registered and could be used to the benefit of patients, the latter being available to patients with ulcerative colitis.
Around 15,000 Poles suffer from Crohn’s disease, of whom 40% do not have access to the treatment they require.
Greater regulation on sales of pseudoephedrine drugs
The Ministry of Health admits that changing the status of drugs containing pseudoephedrine, dextromethorphan and codeine to prescription-only may be the only way to prevent overuse by patients, reported Dziennik Gazeta Prawna (pB10) on Tuesday.
The case primarily applies to drugs used to treat colds and upper respiratory infections, which contain psychoactive substances. While there are already certain regulations restricting sales of such drugs, limiting the dose of active ingredients purchased during one visit to a pharmacy, specifically 720 mg pseudoephedrine, 360 mg dextromethorphan and 240 mg codeine, the problem is that, despite those restrictions, young people still buy them as narcotics, while criminals from neighbouring countries, where such drugs are prescription-only, buy them in bulk to produce methamphetamine.
The officials are now considering limiting access to such drugs, although the responsibility for changing their status lies with the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products.
The officials add that sales of drugs containing pseudoephedrine, dextromethorphan and codeine are being monitored by the Chief Pharmaceutical Inspectorate and that regulations applying restrictions similar to those introduced in Poland were also in place in the UK, France, the Czech Republic and Germany, while research conducted in the UK has shown that such restrictions were effective.
Shortages of tuberculosis vaccine
There is a risk that supplies of a tuberculosis vaccine could be depleted in April because the only supplier, Biomed Lublin, has production problems with its BCG-10 product, reported Dziennik Gazeta Prawna (pA1 &pA4) on Tuesday.
The problem started in December 2018, when Biomed notified the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products that it was forced to temporarily stop producing the vaccine.
As a result, the Ministry of Health decided to use the vaccines from its reserves, which will last until April, while the Chief Sanitary Inspectorate recommended vaccinating children in larger numbers at once to prevent wasting the vaccine, as, under normal conditions only 30-40% of the product is used, while the rest is wasted.
However, this arose from the vaccination schedule which required that the vaccine is administered within 24 hours of childbirth. This changed in 2019 and vaccination is now possible within three days of childbirth, which will give much better usage of the product.
Biomed recently announced that the company has already identified the factors that are adversely affecting the production of BCG-10 and introduced procedures to counter them. However, time-consuming manufacturing and evaluation processes mean the effects will only be visible at the beginning of the second quarter of this year.
Competition authority investigates potential abuse regarding IT systems for pharmacies
The Polish competition authority held inspections at three companies providing IT systems to pharmacies, namely Kamsoft, OSOZ and PEX PharmaSequence at the end of February, reported Dziennik Gazeta Prawna (pB4) on Wednesday.
The inspections were a result of numerous complaints filed by pharmacies about being forced to use particular IT systems recommended by pharma manufacturers in order to take part in promotions of medicines. The problem first started in July 2018, when access to two anticoagulants, Xarelto and Pradaxa, was limited because of shortages in pharmacies not using particular IT systems.
After conducting its inspections, the competition authority admitted the practices could have restricted the competitiveness of pharmacies not using the IT systems recommended by the pharma manufacturers and could have had an adverse effect on the market position of alternative IT systems providers.
Some of the companies providing IT systems preferred by pharma manufacturers argue that they were not in collusion with the pharma manufacturers on discounts, whereas the vice-president of the Supreme Pharmaceutical Council claims such practices restrict access to medications for patients in some pharmacies and it is important to determine what the role of pharma manufacturers is in the potential malpractice.
Importance of personalised cancer treatment
Experts discussing the state of cancer treatment in Poland during the Health Challenges Congress in Katowice agree it is important to introduce a personalised approach and treat patients more individually, reported Dziennik Gazeta Prawna (pA11) on Wednesday.
Professor Marzena Welnicka-Jaskiewicz from the Medical University of Gdansk said one of the solutions to improving cancer treatment is to focus on sequential therapies, including chemotherapy, hormonal therapy and radiotherapy, depending on the type of cancer and individual needs of patients.
Professor Tadeusz Pienkowski from the Oncology Centre in Radom said new therapy options and schemes are becoming available, enabling the complete recovery or substantial extension of life expectancy, but the biggest barrier is still the lack of reimbursement. Another issue is that the time between the registration of new drugs and their actual availability in Poland is extremely long, while numerous reimbursement restrictions and conditions result in limited access to treatment.
Professor Barbara Radecka from the Oncology Centre in Opole added that the bureaucracy around cancer treatment in Poland is very cumbersome for doctors, which often limits treatment options and takes up a lot of their time that could be used more effectively.
Drug recycling could be dangerous for patients
The Ministry of Health (MoH) said leftover drugs brought to medical institutions by patients could be potentially dangerous to patients, reported Rzeczpospolita (pA15) on Thursday.
An inquiry was presented by Jaroslaw Porwich, an MP from the Kukiz’15 party, who claims such a solution would enable the state to cut spending on drugs and reduce the probability of the improper use of leftover opioid drugs.
However, the MoH opposes this idea, adding that there is no way of verifying whether the drugs that are returned to medical institutions by patients had been stored in appropriate conditions, which poses a potential threat. The officials add the only possibility of reusing leftover drugs is humanitarian aid, but this also applies only to drugs which do not require special storage conditions in temperatures of between 2 and 15 degrees Celsius.
5,000 pharmacies could disappear
A recent ruling of the Supreme Administrative Court (NSA) could result in the closure of up to 5,000 pharmacies in Poland, reported Dziennik Gazeta Prawna (pA1 & B4) on Thursday.
The NSA ruled in February that a pharmacist with at least five years’ experience or three years’ experience and an academic specialisation must be present at the pharmacy at all times for it to be open for business.
The problem is that pharmacies often stay open for more than eight hours a day and during weekends, which means that, with a shortage of experienced pharmacists on the market, up to 5,000 pharmacies will no longer be able to operate regularly.
Pharmacists warn that the ruling could have a catastrophic effect for many pharmacy owners and inexperienced pharmacists, as they could be simply replaced by cheaper pharmacy technicians, while the only way of preventing this catastrophe is to immediately amend the regulations.
Puls Biznesu awards Selvita
Selvita received an award from Puls Biznesu for being the second best company listed on the Warsaw Stock Exchange in 2018, reported the newspaper (PB+ supplement, pVI) on Thursday.
Selvita is a Polish biotech primarily focusing on R&D of new cancer drugs. The company currently finances its R&D work through grants, money from investors and revenues from services provided to larger pharmas.
Selvita’s most advanced project is the development of its potential leukaemia drug, SEL24, which is currently in Phase I.
The company sold the rights to it to the Italian group, Menarini, in 2017 for 20 million zlotys (€4.7), but could receive up to 360 million zlotys (€83.7 million) more for reaching milestones and a dozen or so percent from the sales of the drug.
The second project is the R&D of a malignant and solid tumours drug, SEL120, which will soon enter Phase I, and is co-financed by the Leukemia and Lymphoma Society from the U.S. The SEL120 project is to be continued by the company on its own until Phase II.