WARSAW, 19 Oct (APM) - More than 50% of all reimbursable drugs could soon become unavailable if the officials fail to come to an agreement with the pharmas, reported Gazeta Wyborcza (p3) on Monday.
Reimbursement decisions for almost 2,600 drugs will expire at the end of this year and, if no action is taken, the National Health Fund (NHF) will no longer finance them for patients.
However, the manufacturers first need to apply for the renewal of the reimbursement, after which the officials will renegotiate the prices with the pharmas, which takes time. With only 60 working days until the year end, it is already certain that 400 drugs will be removed from the reimbursement list, but it is still unknown whether they will be replaced by equivalents, as the Ministry of Health (MoH) does not have the manpower to conduct all the analyses.
In the case of the remaining 2,200 drugs, the MoH claims that 50% of them have already been formally assessed and 100 have entered the final evaluation stage.
The short deadline is favourable for the pharmas, as it gives them a negotiating advantage if talks are held. Meanwhile, the pharmas say the negotiation process should be eliminated for drugs that are already reimbursed and the decision should be renewed automatically for another two-year term.
The organisational problems in the MoH’s Drug Policy Department arise from the recent conflict between its former head, Iga Lipska, and the rest of the team. The department is currently suffering from power struggles and is short-handed because of exceptionally high staff turnover since the PiS (Law and Justice) party came to power.
The deputy health minister, Marcin Czech, who has been an open supporter of Lipska, refused to comment on the situation. If the officials fail to renew the reimbursement decisions for drugs, patients could encounter problems with continuing their treatment and, if the officials fail to renegotiate the prices, patients and the NHF could be forced to pay more for the medicines.
The reimbursement situation in 2018 is also far from good, as the NHF’s planned budget has been exceeded by 330 million zlotys (€76.7 million) due to various reimbursement decisions of the MoH, while spending on free drugs for the elderly had reached 440 million zlotys (€102.3 million) by the end of August, with the annual limit being 640 million zlotys (€148.8 million).
Debate on drug policy regulations
Officials and health experts have debated the strategic regulations regarding the Polish drug policy which are currently under consultation, reported Rzeczpospolita (pA21) on Monday and Dziennik Gazeta Prawna (pB10 & B11) on Thursday.
The participants agreed that the creation of the national drug policy is a major success overall, but expressed their concerns about particular aspects of the healthcare system that need further improvement.
Marcin Pieklak, lawyer from the Domanski Zakrzewski Palinka law firm, said, while the national drug policy document is a good framework, it has to be followed by other regulations arising from its concepts.
Stefan Boguslawski from PEX PharmaSequence expressed a similar opinion, adding that, while some details in the national drug policy are too specific and should be regulated by separate acts of law, the document opens numerous unresolved subjects, such as the matter of the drug reimbursement limit, which was finally set at 16.5% of the National Health Fund’s budget.
Boguslawski added that the document does not provide any forecast of drug demand in the coming five to ten years and does not mention the drug distribution market, which is currently dominated by domestic companies and should be properly handled to ensure is stays that way, reported Gazeta Prawna.
Former health minister Krzysztof Chlebus said the reimbursement system is insufficiently transparent and access to innovative therapies is inadequate, although there are drugs with an excellent clinical track record that are also cost-effective. Even so, this places the Polish system behind other countries with a similar GDP per capita, such as the Czech Republic, Slovakia and Hungary, reported Rzeczpospolita.
Robert Moldach from the Institute of Health and Democracy is concerned that the document lacks substance in terms of numbers and predictions in terms of improving access to drugs. Although the general objectives are stated, the promises are not substantiated by hard quantifiable objectives, reported Gazeta Prawna.
The former head of the Drug Policy Department at the Ministry of Health and co-author of the regulations, Artur Falek, said the document is open to innovative therapies, but additional financing, such as supplementary health insurance, would be required for this, reported Rzeczpospolita.
Former health minister Igor Radzikowski commented that, while the regulations say access to vaccinations should be improved, they do not obligate the National Health Fund to finance them all, reported Rzeczpospolita.
Former health minister Krzysztof Landa reiterated that, according to an analysis by Delab, the Polish pharma industry could start to decline in the coming five years, which makes the introduction of the reimbursement incentives system (RTR) for companies investing in Poland critical. This was supported by the vice president of the Polish Association of Pharma Industry Employers, Barbara Misiewicz-Jagielak, who said domestic pharmas have every intention of providing patients with good access to drugs, but need a rationally functioning reimbursement system to make it happen. She added that the R&D of a new biologic or biosimilar can last between seven and nine years and costs between 200 and 400 million zlotys (€46.5-93 million), for which the RTR is necessary, reported Rzeczpospolita.
Prison threat for incorrect storage of OTC drugs
According to the new regulations being prepared by the Ministry of Justice (MoJ), all entities distributing over-the-counter (OTC) drugs could face up to five years’ imprisonment for incorrectly storing such products, reported Dziennik Gazeta Prawna (pB6) on Monday.
This applies to hypermarkets, petrol stations and many other small shops, which often sell basic OTC drugs, such as analgesics. Pharmacists have been flagging the issue of improper storage conditions of these drugs for a long time, but experts say the new regulations are absurd and the punishment is far too severe. They add that the regulations should only apply to products which could threaten patients in any way if stored incorrectly and not all OTC drugs across the board.
The MoJ says the current system of administrative fines is ineffective and the new penalties would be applied in cases where entities are fully aware of the dangers created through incorrect storage.
Poland's biotech industry lags
Experts say that although R&D spending in the Polish biotech industry is increasing and overall market conditions are improving, Poland is still far behind many other EU member states, reported Dziennik Gazeta Prawna (pA1 & pA12) on Monday.
Bogna Cichowska-Duma from INFARMA said biotechnology is a very risky sector, as the development of originator drugs requires an average of 12 years of R&D, involvement of 1,000 scientists and funding of up to 8 billion zlotys (€1.86 billion). She said only one in 8,000 molecules are commercialised, which is why very few Polish companies go down this path.
According to Polpharma, Poland’s biggest pharma, the three main barriers to growth of the industry are poor access to funding, inadequate infrastructure and a lack of cooperation between scientific institutions. Company experts also say the EU funds disbursed by the National Centre for Research and Development are simply insufficient to help entities working on new drugs throughout the entire R&D process.
The cooperation between pharmas and scientific institutions is improving due to regulatory changes, including the government Biotech Development Programme, the idea of establishing the Biotech Pharmaceutical Institute and the confirmed establishment of the Medical Research Agency. Furthermore, Poland has 4,000 new biotech graduates every year and an increasing number of Polish pharmas, including Adamed, are starting to work with scientific institutions on clinical trials on their own.
Cichowska-Duma said an ecosystem is needed to promote innovative development, which should encompass Polish and international pharmas, start-ups and scientific institutions. All this could lead to the development of Polish originator drugs or biosimilars, while one way of achieving this would be to encourage companies to invest in Poland by introducing a transparent tax relief system and reimbursement preferences.
The global biotech industry grew from $270.5 billion in 2013 to $414 billion in 2017. Around 180 Polish companies are broadly involved in the biotech industry, while their internal spending on biotech-related activities is almost 800 million zlotys (€186.1 million) per year.
Officials want to vaccinate foreigners and refugees
The Ministry of Health (MoH) wants to introduce new regulations requiring foreigners and refugees from outside the EU to be vaccinated against contagious diseases, such as measles or tuberculosis, reported Rzeczpospolita (pA1, pA2 and pA12) on Monday.
The former chief sanitary inspector, Marek Posobkiewicz, said the cost of these vaccinations would be several tens of millions of zlotys, but it would be worthwhile given the potential dangers arising from several hundred thousand unvaccinated students and workers from the East, especially Ukraine, living in Poland.
It is said that such changes are unwarranted and business owners are concerned this could lead to difficulties for their potential employees.
The MoH also wants to increase the list of professions allowed to perform vaccinations, including qualified pharmacists, nurses and midwives.
Another contaminated active ingredient from China discovered
The European Medicines Agency has discovered that another active ingredient from Chinese suppliers, irbesartan, is contaminated, reported Dziennik Gazeta Prawna (pB1) on Wednesday.
The EMA is currently verifying the quality of other sartans, such as candesartan, losartan and olmesartan, which are supplied by Asian companies to European pharmas. These ingredients are mainly found in drugs used for cases of high-blood pressure and after strokes.
The officials have already confirmed that some tested samples of irbesartan contained a carcinogenic compound similar to NDMA-NDEA. NDMA was recently found in valsartan, also from China, which resulted in many high blood pressure drugs being recalled from the EU markets.
Experts were warning that the system of checking the quality of active ingredients imported to Europe from Asia has shortcomings long before the valsartan case and that contaminations may only be detected after several years, sometimes by accident.
Professor Zbigniew Fijalek said each of the 16,000 drugs available in Poland is properly tested once every 25 years, which shows the scale of the problem.
However, the EU officials seem to be opposed to imposing stricter quality control systems for drugs, as this would increase prices.
Dziennik Gazeta Prawna published an interview with two of Amgen’s executives, Philip Tagari and Brian Bradbury, on the company’s areas of focus and the future of the Polish biotech industry on Thursday (pA11).
Tagari said the company is focusing on six therapeutic areas, namely oncology, haematology, nephrology, neurology, as well as cardiovascular and inflammatory diseases. He added that Poland should be focusing on aspects such as gathering and analysing data, but also developing technologies used in cell or gene therapies and cancer vaccines, as the level of education provided by Polish universities in mathematics and statistics is high.
Tagari believes future therapy will be based on highly personalised drugs and those that target genetically defined segments of the population.
Bradbury said cooperation between pharma companies and public institutions is necessary, as the synergies arising from it bring patients phenomenal results.
Dziennik Gazeta Prawna carries an interview with Bioton’s CEO, Slawomir Neumann, on the company’s current activities and plans for the future on Friday (pA18 and pA19).
Neumann said Bioton is focusing on adding insulin analogues to its portfolio to have a complete range of insulin products and provide more therapeutic options for doctors and patients. He added that the molecules are already developed, the company has gone through the entire production process and is working on optimising this for mass production.
Neumann claims Bioton’s insulin analogues should be available on the market within four years and that reaching the expected production capacity does not pose any risks, as the company has the know-how and experience to achieve it.
The company is also actively increasing its human insulin output, because, although the market is smaller than in the case of insulin analogues, the maintenance of this segment and expansion to additional markets will help the company obtain funding for the development of the analogues segment. Neumann said the company still needs €100-120 million, while the funding could be secured through cooperation with a bigger player.
Neumann also referred to the recent conflict with one of the company’s minority shareholders, who questioned the sales of Bioton’s Singaporean subsidiary, SciGen. He said the turmoil caused certainly does not help Bioton and consumes a great deal of resources, but he hopes it will be resolved as soon as possible without overly affecting the business. Although the investment in SciGen failed, Bioton managed to retrieve 100 million zlotys (€23.3 million) in cash and an insulin licence by selling the company.
Ukrainian health expert on anti-vaccination lobbies
A renowned Ukrainian health expert, Jewhen Komarowski, believes Poland should oppose the anti-vaccination lobbies to prevent a measles outbreak such as that currently taking place in Ukraine, reported Dziennik Gazeta Prawna (pA1 and pA4) on Thursday.
Ukraine has had 33,000 cases of measles just this year, which led to 14 deaths and, with the highest percentage of unvaccinated citizens in Europe, the country is struggling to regain control over the situation.
Komarowski claims the issue arises from anti-vaccination lobbies growing in strength in recent years following isolated reports of complications caused by vaccines and the ongoing anti-vaccination propaganda. He added that Poland should learn from the mistakes of others and take all the necessary steps to avoid the Ukraine’s current situation.
Poland has had 114 cases of measles this year, but the number of parents refusing to vaccinate their children is growing rapidly, reaching 30,000 in 2017, whereas the government is considering the possibility of making vaccinations voluntary.
UK legalised medical cannabis
The UK Home Office is allowing doctors to prescribe drugs based on medical cannabis to their patients from 1 November, reported Puls Biznesu (p20) on Monday.
The decision to prescribe such drugs will be limited to specialist doctors, such as neurologists and paediatricians, but only if no suitable equivalents are available on the market. The new regulations are primarily supposed to improve the situation of epilepsy patients.