Press review

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Polish legal expert says EU plans to combat drug counterfeiting could hit hurdles

Country : Germany, Poland

Keywords :
WARSAW, 7 Dec (APM) - A legal expert from the GESSEL law firm, claims that, while the EU wants to eliminate counterfeit drugs from the market by introducing directives curbing it, member states and entities operating within the pharma industry could have difficulties implementing them, reported Rzeczpospolita (pA18) on Monday.
The EU wants to create a system for monitoring drug sales, which is to include most prescription and selected over-the-counter medicines.
However, the system will have to be properly implemented in all EU member states to guarantee that it will work. All drugs included in the system will require special labelling to verify their origin at every stage of distribution. If, at any stage, the origin of a drug cannot be confirmed, it will be automatically flagged for withdrawal.
Adam Kraszewski says that, in order to get the system to work properly, marketing authorisation holders and importers need to be prepared to introduce special labelling and input the drug information into the central register run by the European Medicines Verification Organisation and its country-specific counterparts.
According to the regulations, all costs of the new labelling will need to be covered by the pharmas, although wholesalers and pharmacies will be forced to buy special scanners and software needed to track the medicines and train their staff to ensure the proper operation of the system.

Ruling on hospital drug tenders and best medical knowledge

According to the ruling of the administrative court in Warsaw, which supported the claims of the Patients’ Ombudsman, hospitals should treat patients on the basis of their best medical knowledge instead of the outcome of drug tenders, reported Dziennik Gazeta Prawna on Monday (pA3) and on Friday (pA19) and Rzeczpospolita (pA15) on Thursday.
The case applied to a therapy which could be conducted with two equivalent drugs, the first being a biologic that costs 5,000 zlotys (€1,165) and the second being a biosimilar costing 4,000 zlotys (€932), reported Dziennik Gazeta Prawna on Monday.
In the tender, the hospital in question decided to choose the cheaper biosimilar with the same active ingredient as the biologic and switched patients to the new therapy. The hospital admitted that it would still base its future decisions on the outcome of tenders, even if switching patients to the cheaper drug results in complications. However, the Patients’ Ombudsman argued that such decisions should always be based on best medical knowledge, reported both newspapers.
The National Health Fund encourages hospitals to keep switching patients to cheaper equivalents of drugs already used when new medications are added to the reimbursement list. This approach is questioned by patients, manufacturers of originator drugs and some doctors. However, experts are divided, as some claim that patients should be treated in accordance with the best medical knowledge, while others say choosing cheaper equivalents offers greater access to treatment, reported Dziennik Gazeta Prawna on Monday.
Agnieszka Jagiello-Gruszfeld, a doctor from the Oncology Centre in Warsaw, said that, based on her experience with three clinical trials of Herceptin equivalents, she has no objections to prescribing therapies based on biosimilars to new patients, or those already on intravenous Herceptin.
The only exception applies to Herceptin administered subcutaneously, as she would prefer not to switch patients already receiving it, unless forced by management. She added that doctors are concerned that, even if they switch patients to cheaper biosimilars, there is no assurance that the additional money will be used to treat more patients, as the officials may use the savings in other areas. She added that such an incentive would certainly make the process of switching patients to biosimilars easier and more effective.
Jagiello-Gruszfeld said that the list of reimbursable drugs is fairly complete, but there are some niches that could be improved, such as access to TDM-1, reported Dziennik Gazeta Prawna on Friday.
The ruling is strongly criticised by the Polish Association of Pharma Industry Employers and the Polish Society of Rheumatology, which claim that all recent research shows that biologics and biosimilars can be safely switched and that, in view of how the reimbursement regulations work, the big advantage of biosimilars is that they must be at least 25% cheaper than their biologic equivalents, reported Rzeczpospolita.
The court’s ruling is not final, so the case may be taken to the Supreme Administrative Court, reported both newspapers. However, if the Supreme Administrative Court decides to uphold it, experts are concerned that it will be applied to all biologics and biosimilars, resulting in much higher spending of the National Health Fund, reported Rzeczpospolita.

Access to prostate cancer treatment should be improved

While prostate cancer is the second most frequent cancer affecting male patients and the number of innovative therapies is increasing, access to them is still restricted in Poland, reported Rzeczpospolita (pQ1) on Tuesday.
Professor Pawel Wiechno from the Oncology Centre in Warsaw claims it is extremely important to give patients access to the most innovative prostate cancer therapies, as research shows they enable this type of cancer to be treated as a chronic, rather than an outright deadly disease.
Patients also say the prostate cancer drug programme, which was expanded last year, is still very restrictive, as it does not allow for the sequential administration of the drugs from the drug programme in treatment after chemotherapy. Furthermore, in the case of patients before chemotherapy, the programme allows for the use of only one drug that does not always prove effective.
Lukasz Szmulski from the Ministry of Health said some of the restrictions arise from the way the reimbursement system is organised and the officials are forced to consult pharmas on some of their decisions. However, he added that the regulations are currently being revised and the officials are in the process of assessing the potential reimbursement of two new drugs, cabazitaxel and enzalutamide.

Poland could be classified as a country spreading measles

Poland is at risk of the World Health Organization (WHO) classifying it as one of the countries spreading measles because of the recent outbreak of the disease, reported Dziennik Gazeta Prawna (pA1-A2 ) on Wednesday and Gazeta Wyborcza (Tylko Zdrowie supplement, p3) on Friday.
While the WHO is to make its decision within a month, experts are concerned that Poland could be shown a red card, as the number of measles cases increased from 62 in 2017 to over 220 in 2018 and the risk of developing a Polish strain of the disease is high.
Poland received the status of a measles-free country in 2016 and kept it in 2017, but the percentage of population vaccinated against the disease dropped this year below the 95% mark, reported Dziennik Gazeta Prawna.
The WHO says the number of cases of measles increased by 30% from 2016 to 2017 and that the disease kills 100,000-110,000 patients globally each year, even though vaccines are available, reported both newspapers. The percentage of the global population vaccinated with one dose has not exceeded 85% in recent years, while the percentage vaccinated with two doses, which practically guarantees immunity, has been around 67%, reported Gazeta Wybrocza.
One of Poland’s neighbouring countries, which are very likely to lose their measles-free status this year, is Germany, where parents make the decision on whether to vaccinate their children, reported Gazeta Wyborcza.

Access to medical cannabis still restricted

While medical cannabis was legalised in November 2017, products based on it are still not available in pharmacies and patients resorting to illegal sources are persecuted, reported Gazeta Wyborcza (p7) on Wednesday.
Doctors who want to prescribe medical cannabis to their patients have to request approval from the national consultants, which then has to be approved by the Ministry of Health.
Furthermore, medical cannabis cannot be grown in Poland and must be imported. The first and only company willing to enter this business filed its application with the officials in June. Even after all the approvals are granted and medical cannabis becomes available in pharmacies, there still is a problem of the small number of doctors and pharmacists fully qualified to prescribe and prepare such drugs.
So far, only one registered cannabis-based product is available on the Polish market in the form of an aerosol.

Chief Sanitary Inspectorate wants to reduce the threat of measles epidemic

The Chief Sanitary Inspectorate (GIS) is looking for ways to reduce the threat of a measles epidemic in Poland and contain the current outbreak, reported Dziennik Gazeta Prawna (pA2) on Thursday.
While a significant number of cases of measles in Poland was recently caused by infected workers from Ukraine, the GIS believes both foreigners and Poles must be vaccinated against the disease to prevent further outbreaks. That is why the officials say employers need to be involved in the process, which would require new regulations and new rules for financing vaccinations.
The Ministry of Health and Ministry of the Interior and Administration say they are working on specific proposals, but refuse to further comment on the situation.

Vaccination supporters have their own bill

Vaccination supporters intend to file a bill encouraging vaccinations with the Speaker of the Sejm on Thursday, reported Gazeta Wyborcza (p4) on Wednesday and Dziennik Gazeta Prawna (pA2) on Thursday.
According to the bill, admission to public nursery schools should depend on having all the obligatory vaccinations. Once the Speaker accepts the bill, the initiators will have to collect 100,000 signatures within three months for the Sejm to vote on it.
The recent bill on making all vaccinations voluntary prepared by the STOP-NOP anti-vaccination organisation raised over 120,000 signatures, but was ultimately rejected by the Sejm, reported both newspapers.
Some doctors and legal experts also believe obligatory health insurance contributions should be increased from the current 9% to 12% of income for parents refusing to vaccinate their children, reported Gazeta Wyborcza.
The number of cases in which parents refuse to vaccinate their children was over 30,000 in 2017 and, while such actions can result in fines of up to 10,000 zlotys (€2,331), in practice, the officials have no way of enforcing them, reported Gazeta Wyborcza.

Debate on biotech industry in Poland

Experts debated the development and future of the Polish biotech industry, reports Rzeczpospolita (pA13) on Friday.
One opportunity for Polish biotechs is the establishment of the Medical Research Agency (ABM), which will be primarily responsible for organising non-commercial clinical trials. Roman Topor-Madry, head of the HTA agency, added that the ABM will be very useful for analysing clinical efficacy and cost-effectiveness for reimbursement decisions.
Jan Stanilko from the Ministry of Entrepreneurship and Technology said that simply pumping additional money into the industry through the ABM will be insufficient; communication between research centres and scientific teams must also be improved. Additional issues apply to the relatively small size of teams and the complexity of projects conducted in Poland, a lack of modern medical registers and insufficient cooperation between researchers and commercial partners.
Marta Gajecka, an adviser to the Polish President, said that, in order to think about the development of the biotech industry, Poland must satisfy two criteria, namely offer a good legal environment and access to financing, which is currently insufficient, even with EU grants. This was confirmed by Amgen’s Peter Grandsard, who said Poland has many talented individuals and great potential, but needs to define its strategy for the biotech industry and invest in the branches with the best prospects.
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