Press review

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Poland's Ministry of Health looks to speed up drug registration procedure

Country : Belarus, Hungary, Poland, U.S., UK

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WARSAW, 9 Nov (APM) - The Ministry of Health (MoH) admits that the drug registration procedure in Poland is slow, which leaves patients waiting for access to innovative therapies and is considering speeding it up, reported Rzeczpospolita (pA16) on Monday.
The solution would be to introduce a “scientific advice” mechanism, according to which officials from the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products would provide pharma companies and wholesalers with guidelines on how to file the documentation to make the process more effective and faster.
Similar mechanisms are applied in other countries and the officials could also introduce it for companies filing for the reimbursement of their drugs, which would be conducted by the MoH.
However, representatives of pharmas say that in order to make the latter happen, the number of officials working in the Drug Policy Department would have to be increased, as the departments is already heavily understaffed.

Pharma industry highlighted in Poland’s development strategy

As the sixth largest pharma market in Europe, with a value of 31 billion zlotys (€7.2 billion) and constant growth, the Polish pharma industry is highlighted as a strategic industry, reports Rzeczpospolita (Najwazniejsze Innowacje Stulecia supplement p54) on Friday.
According to the industry statistical yearbook 2017, 378 pharmas were manufacturing drugs in Poland in 2016, primarily small and medium sized enterprises, with total average employment of 22,800. The industry employed over 1,000 R&D specialists, while R&D spending amounted to 270 million zlotys (€63 million). As a result, the government has highlighted the pharma industry in Poland’s development strategy.
While the market is growing, the structure of products is also changing, with the proportion of sales of over-the-counter products and hospital drugs increasing faster than reimbursable and non-reimbursable drugs.
Cardiovascular, digestive and metabolic, respiratory and nervous system drugs accounted for the largest share of reimbursable drugs, while oncology and immune system drugs represented 40% of the hospital market.
The value of the OTC drugs market in 2017 was 10.4 billion zlotys (€2.4 billion. OTC drugs are taken by 73% of the population and 66% take herbal medicines, while 95% of the population opt for self-treatment.
The value of drug imports was 22.3 billion zlotys (€5.2 billion), while the value of exports was 11.7 billion zlotys (€2.7 billion) in 2016. Trade is primarily with the European Union, whereby expensive originator drugs are imported, while generics are exported.
Although the Polish pharma industry is based on chemical drugs, mainly generics, the availability of originator drugs is greater in hospitals than in pharmacies, while increasingly more Polish pharmas are starting work on the production of biotech drugs.

Reimbursement development procedure may attract large players

Unless Poland introduces the reimbursement development procedure, foreign pharmas may bypass Poland, while those already manufacturing in Poland could relocate their factories reported Rzeczpospolita (Najwazniejsze Innowacje Stulecia supplement p56-57) on Friday.
Two years have passed since the health ministry’s announcements of the reimbursement development procedure, namely reimbursement preferences for pharmas investing in production in Poland. The government was planning to cover up to 10% of the costs of drug reimbursement to a value of 2 billion zlotys (€466 million), giving investors savings of 200 million zlotys (€46.6 million).
The payback on this investment would come later through the creation of new jobs and better availability of drugs. Therefore, the objective was to use reimbursement funds to help future development.
However, the project became stuck in September 2017 at the interministerial agreement stage, with the source of financing being disputed with the ministry of development and health.
Although the State Drug Policy recently accepted by the government refers to incentives for pharma investors, no information is being provided about the types of incentives, which is thought to mean that they are inconsistent with EU law on equal access to markets.
Meanwhile, analysts from DeLab suggest that if Poland fails to introduce the reimbursement development procedure within three to five years, foreign companies are likely to not only not establish production plants in Poland, but may also relocate their Polish factories to other countries.
Krzysztof Kopec, president of the Polish Association of Pharmaceutical Industry Employers said spending on reimbursement is equal to the level of state budget receipts, so the activation of the reimbursement development procedure would be an opportunity that is not currently used.
The association claims this procedure would help increase Polish GDP by 534 million zlotys (€124 million), of which the pharmaceutical sector alone would account for 22 million zlotys (€5 million). It would also increase the legal stability of the pharmaceutical sector and would help stabilise the pricing/reimbursement and regulatory policy.

Poland could become drug development hub

With a large number of expiring drug patents, Poland could soon become a generic and biotech drug development hub, reported Rzeczpospolita (Najwazniejsze Innowacje Stulecia supplement, p58) on Friday.
Polish manufacturers will shortly be able to start producing generics of drugs upon the expiry of their patent protection and, as, in accordance with the reimbursement regulations, such medicines have to be 25% cheaper than originator drugs, there is a big chance they could be included in the reimbursement list.
The advantage of Polish pharmas is that they specialise in producing generics , which could fuel their expansion and provide them with additional resources to invest in innovative projects. The biggest Polish players operating in the generics segment have the experience, know-how, infrastructure and scale to step up to the challenge, with Polpharma and Adamed leading the field.
According to the Central Statistical Office, the Polish pharma industry is the most active segment of the economy in terms in innovation and is growing rapidly. While its share of Polish GDP is still fairly low, resting at 1.33%, it is growing twice as fast as in other EU countries.

Price of a post-transplant drug for children increased again

Parents of children after transplants warn that the price of the only available reimbursable antiviral solution, valganciclovir, was increased again in the most recent reimbursement list, reported Rzeczpospolita (pA16) on Monday.
The price of the drug increased from 316.8 zlotys (€73.7) in March 2017 to 924.3 zlotys (€215) in November this year. While the Ministry of Health (MoH) claims the price increases arise from new drugs being added to the list, parents say all the alternatives are in the form of tablets. This means that they can either pay more for the drug, or take their children to hospitals, where the solution is administered free of charge, but they risk dangerous infections.
Legal experts say that the officials could create a separate reimbursement group for the valganciclovir solution, but the MoH rules out such a possibility, as it could antagonise other manufacturers.

More cases of measles reported in Poland

The number of new measles cases reported across Poland is increasing, which could lead to an outbreak in view of the declining percentage of vaccinated Poles, reported Gazeta Wyborcza on Saturday (p2 and p4), Monday (p5) and Tuesday (p5) and Wednesday (p7) and Friday (Magazyn Warszawa, p10), Dziennik Gazeta Prawna on Monday (pA1 and pA5) and on Tuesday (pA8-A9) and Wednesday (pA1 and pA4) and Rzeczpospolita on Monday (pA1 and pA5) and on Thursday (pA17).
Experts say the risk of a deadly epidemic is realistic and mainly arises from the increasing number of parents refusing to vaccinate their children. The number of such parents increased tenfold, to over 30,000 from 2010 to 2018, reported Gazeta Wyborcza and Gazeta Prawna.
Over 41,000 cases of measles were reported in Europe in the first half of 2018, which was the highest number in eight years. It is believed that many infections are caused by workers from the East, from countries such as Ukraine and Belarus, where the percentage of the unvaccinated population is much lower than in Poland and the rest of Europe, reported Gazeta Wyborcza.
At the beginning of October, the Polish Sejm started work on a bill filed by anti-vaccination supporters, according to which all vaccinations would be voluntary. The bill, signed by over 100,000 Poles, was criticised by the Ministry of Health, the Supreme Medical Council and the Chief Sanitary Inspectorate (GIS), reported Gazeta Wyborcza.
The health minister and chief sanitary inspector held a press conference at which they assured the public that the most recent outbreak resulting in 17 new cases has been contained, reported Gazeta Wyborcza, Gazeta Prawna and Rzeczpospolita. The health minister also said the government opposes making all vaccinations voluntary and the percentage of the vaccinated population needs to be kept over 95%, which is considered safe, although the National Institute of Public Health - National Institute of Hygiene warns that, in the case of measles, this percentage actually dropped to 94% for patients vaccinated with one dose and to 93% for patients vaccinated with two doses, reported Gazeta Wyborcza.
Experts believe 5.5-6 million Poles could be at risk of contracting measles.
The officials have already decided that the second MMR vaccine will be administered not to 10-year-olds but to six-year-olds from 2019, which is supported by health experts. Unfortunately, free vaccinations will still only be available to children, while adults will have to pay 150 zlotys (€35) for them, reported Gazeta Prawna on Wednesday.
The government is also working on new regulations, according to which parents, whose children suffered from vaccination complications, would be eligible to receive compensation of up to 70,000 zlotys (€16,279) if they are hospitalised for longer than 14 days, but the current shape of the bill has been recently contested by the health minister, who is concerned about potential abuse. The idea of paying compensation to parents is supported by the Kukiz'15 party, which is soon to file its own bill, reported Rzeczpospolita (pA17) on Thursday.

Poles do not believe in vaccinations

Poland has one of the lowest levels of trust in vaccinations in the EU, reported Gazeta Wyborcza (p18) on Wednesday.
According to the report prepared by the European Commission, only 75.9% of Poles believe vaccinating children is important, 72.4% that vaccines are safe, 74.9% that they are effective and 59.3% that vaccinations are in line with their religious beliefs.
These results put Poles among the most adamantly anti-vaccination nations in Europe, whereas the number of parents refusing to vaccinate their children reached 34,000 in the first half of the year, and the percentage of vaccinated population in Poland is at the 94% mark, which is 1 percentage point below the 95% mark recommended by the World Health Organisation.

Bill on voluntary vaccinations rejected

The Polish Sejm’s Health Commission rejected the bill prepared by the STOP NOP anti-vaccination organisation on making all vaccinations voluntary on Thursday, reported Gazeta Wyborcza (p10) and Rzeczpospolita (pA29) on Friday.
The voting was most probably affected by a rapid increase in the outbreak of measles throughout Poland, reported Gazeta Wyborcza.
The STOP NOP organisation is unhappy that the bill was rejected and announced further initiatives on the matter, including a bill on the establishment of an alternative medical chamber and the formation of a new political party to stand in the forthcoming general election, reported Gazeta Wyborcza.
The number of parents refusing to vaccinate their children was 30,000 in 2017 and could be as high as 40,000 in 2018, reported Gazeta Wyborcza.

Victims of vaccination complications still have no access to compensation

Despite all the earlier promises, the special compensation fund for victims of vaccination complications has not yet been established, while the Ministry of Health claims that the regulations must be more precise to avoid potential abuse, reported Rzeczpospolita (pA17) on Tuesday.
Originally, according to these regulations, parents whose children suffered from immediate complications arising from obligatory vaccinations and requiring at least 14 days of hospitalisation, would be eligible for compensation of up to 70,000 zlotys (€16,279).
However, patient organisations opposed the rule, saying that the appearance of the complications was supposed to be immediate and the compensation was to be a one-off payment. The officials argued that the intention was to offer quick support to parents and that receipt of the compensation would not rule out taking the matter to court.
However, the current health minister, Marcin Szumowski, claims that the regulations need to be reviewed and made more specific, as their current wording could encourage abuse, filing false reports or pressuring doctors, which would only strengthen the growing belief that vaccines might be dangerous.

GLG Pharma’s clinical trials could be postponed

IQ Pharma, which was supposed to run clinical trials for GLG Pharma’s potential triple negative breast cancer drug, recently decided to withdraw from the deal, which means the trials could be delayed, reported Puls Biznesu (p8) on Tuesday.
IQ Pharma said it would be unable to complete the trials within the agreed schedule and budget because of unforeseen circumstances. GLG Pharma claims it will be able to coordinate the trials with contractors or find another company willing to do so, but it is very likely that the trials will be delayed in such a scenario.
Furthermore, GLG Pharma CEO, Piotr Sobis, decided to leave the company.
The drug the company is working on could be potentially effective in triple negative breast cancer and is based on pyrimethamine used for treating malaria. GLG Pharma was originally hoping to start phase 1 at the turn of the first quarter of 2018 and then, after reaching Phase II, to find a partner securing a deal of up to 40 million zlotys (€9.3 million).

Polpharma is investing in biotechnology

Poland’s largest pharma, Polpharma, has been investing in biotechnology since 2010 reports Rzeczpospolita (Najwazniejsze Innowacje Stulecia supplement p55) on Friday.
The company has already invested 700 million zlotys (€163 million) and ultimately plans to invest 2 billion zlotys (€2 billion), creating approximately 800 jobs. It has been working on the development of bioequivalents to achieve faster and lower cost results, although the development of bioequivalents still lasts approximately 7-10 years and costs approximately 100-200 million dollars. The company has three products at advanced stages of development and others at their early stages.
Polpharma is the only pharma in Poland with the ability to control the whole of the biotech development process from the development of innovative cell lines through product development, to production. Markus Sieger, president of Polpharma said that, as only global marketing of bioequivalents gives the ability to cover development costs, this is an opportunity for Polish pharmas to expand abroad.

AstraZeneca to boost investment in Poland

AstraZeneca is increasing its employment and intends to invest 1.5 billion zlotys (€348.8 million) in Poland over the coming five years, reported Puls Biznesu (p6-p7) on Thursday.
The company invested 276 million zlotys (€64.2 million) in Poland in 2017 and intends to focus on increasing the capabilities of its Polish team which is responsible for the most innovative therapies. AstraZeneca currently has approximately 1,550 employees in Poland, but intends to grow the team to 1,800 employees within a year. The Polish unit coordinates global research and is responsible for clinical trials conducted in Poland.
While the Polish clinical trials market is growing, the number of trials conducted per capita is still 50% lower than in countries with similar economies, such as Hungary. Poland is currently the second largest clinical trials market for the company in terms of the number of patients involved and AstraZeneca believes the conditions for improvement are good, as healthcare spending could grow to 6% of the GDP in the future.
While AstraZeneca spent $5.4 billion on R&D in 2017 and has a budget for partnering with domestic companies conducting research into new drugs, the head of the Polish branch, Jaroslaw Oleszczuk, said there are still only a few biotechs working on new drugs in Poland, compared to more developed markets, such as the UK or the U.S.

OncoArendi Therapeutics could sign partnership deal in 2019

OncoArendi Therapeutics, which had its debut on the Warsaw Stock Exchange and made 58 million zlotys (€13.5 million) from the move in April, could sign a partnership deal with a major pharma player for its AOTD-01 particle in 2019, reports Puls Biznesu (p8) on Friday.
AOTD-01 is the most advanced moecule developed by the company. The anti-inflammatory molecule that could be potentially used for treating asthma, sarcoidosis and pulmonary fibrosis could soon enter Phase 1b with the results of the trials being known in the second quarter of 2019.
The company will soon have to decide on the indications in which the particle is to be tested during the second stage of the trials, which could begin in the last quarter of 2019, as it would not be possible to commercialise it for all indications given the differentiated prices of treatment and reimbursement levels between the diseases. If the company were to continue the development of the project on its own, it would steer it towards sarcoidosis, but the final decision will be tied to the partnership negotiations with the major pharmas.
OncoArendi is also working on another molecule, AOTD-02, which is an arginase inhibitor for use in cancer immunotherapy. Preliminary testing showed that the particle is more effective at preventing tumour growth than a similar particle developed by the U.S. company, Calithera, but OncoArendi will now have to focus on conducting pre-clinical toxicology testing. If AOTD-02 proves safe, the molecule could be administered to the first patients at the end of 2019.
The company is also working on a third molecule that could enter clinical trials in the future, and will use its know-how gained during the development of AOTD-01.
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