WARSAW, 15 Feb (APM) - While the government has been promising to introduce a mechanism of reimbursement incentives for pharma companies investing in innovation in Poland, the entire initiative is being delayed by the lack of IT solution to support its implementation, reported Puls Biznesu (p6 - 7) on Tuesday.
The mechanism was initially supposed to start operating in the first quarter of 2018, giving a simplified reimbursement procedure for companies with R&D centres in Poland, employing domestic scientists and not avoiding taxes.
However, the first tender for introducing the mechanism was only organised recently this year. The officials claim the delay was caused by the fact that the whole project is complicated and requires cross-departmental cooperation and involves integration with the Reimbursement Act. It is still unknown which companies could actually be the beneficiaries of the proposed mechanism.
New regulations targeted at illegal drug exporters
The government accepted the regulations intended to curb the problem of illegal drug exports and deal with entities involved in such activities on Tuesday, reported Puls Biznesu (p7) and Dziennik Gazeta Prawna (pB5) on Wednesday.
According to the regulations, all entities from the drug distribution chain, and not just the pharmacy owners, will be held liable for involvement in any activities related to illegal drug exports, which includes imprisonment.
The regulations also specify all cases in which pharmacies can sell drugs and the patients who can buy drugs online and have them delivered. Finally, the regulations grant pharmaceutical inspectors more powers and provide them with more tools to fight any irregularities on the market. The regulations should be assessed shortly by the Polish Sejm, reported both newspapers.
The value of illegal drug exports is estimated at 2 billion zlotys (€461 million) a year, reported both newspapers, with a total Polish pharmacy market of 34.6 billion zlotys (€8 billion) in 2018, reported Puls Biznesu.
Polish government tightening up regulations on drug trading
The Polish government has introduced an amendment on the trading of medications between wholesalers and pharmacies to help prevent illegal drug exports, reported Rzeczpospolita (pA12) on Wednesday,
According to the proposed changes, wholesalers will be prohibited from buying drugs from individual retailers, such as pharmacies, including those owned by the wholesalers. Furthermore, the penalty for illegal exports has been increased from three months to five years, six months to eight years for large-scale offences, and when a medication is difficult to obtain on the Polish market because of illegal drug exports - the perpetrators could face from one to ten years’ imprisonment.
Also, in order to facilitate inspections by pharmaceutical inspectors, any attempts leading to the obstruction or prevention of their activities will be punishable with up to three years’ imprisonment, instead of two, as is the case today.
Officials want to cut spending on AIDS treatment
The Ministry of Health (MoH), which is directly responsible for financing the treatment of patients with HIV, believes the current treatment plan is too expensive, reported Dziennik Gazeta Prawna (pA8) on Wednesday.
The officials, experts and companies producing generics, who support the claim, say too much money is spent on the expensive newer drug, Descovy, compared to Truvada and its generics, which are the first choice in most other countries.
They add that Descovy treatment can be up to 33 times more expensive than the cheaper alternatives, while the effects are very similar. However, the director of the National AIDS Centre, Anna Marzec-Boguslawska, disagrees that the drugs are equivalent, saying that Descovy has fewer adverse effects and a lower mortality rate. She added that the HTA Agency clearly stated that both of them should be reimbursed for patients.
The MoH recently decided to stop organising tenders for the drugs once a year, in favour of every two months, as the officials are considering the inclusion of HIV drugs in the reimbursement list, which would allow for more aggressive price negotiations with manufacturers.
Approximately 3,370 HIV patients in Poland use Descovy, while 605 use Truvada. The MoH allocated 318 million zlotys (€73.3 million) to HIV drugs in 2019.
Demand for medical cannabis higher than expected
The first delivery of 7 kilograms of medical cannabis, which entered Polish pharmacies in the second half of January, is already sold out, reported Dziennik Gazeta Prawna (pA1 & pA5) on Monday.
Spectrum Cannabis, the only licensed importer of the product in Poland, claims that if not for rationing in pharmacies, which involved the provision of prescriptions before any deliveries are made, the entire stock could have been depleted within a few days.
The company says future deliveries of medical cannabis will be larger, with up to 15-20 kilograms being planned within two weeks, 50 kilograms in March and around 100 kilograms per month by the end of the year.
Medical cannabis is not reimbursed in Poland and patients currently only have access to dried cannabis, containing 19% THC and 1% CBD, primarily used for pain treatment, although the company should introduce two stronger varieties of dried cannabis in May, which could be used in multiple sclerosis and treatment of adverse effects caused by chemotherapy and radiotherapy.
Additionally, Spectrum Cannabis intends to supplement its range with oils and capsules by the end of the year, provided it receives authorisation, and believes the new forms will significantly increase demand due to easier application and lower cost, especially since the administration of the dried product requires special devices which cost several hundred zlotys.
Some doctors are still sceptical about prescribing medical cannabis, but patients say the biggest barrier is poor availability in pharmacies. The situation could change when new suppliers enter the market, but the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products is not disclosing whether additional entities have already applied for the required permits.
Medical cannabis is currently available in pharmacies at 65-70 zlotys per gram, partly because it is subject to 23% VAT instead of 8%, as in the case of other pharmaceutical raw materials, which is being contested by the company.
Anti-vaccination lobby growing in strength
The number of Poles refusing to vaccinate their children soared from around 30,000 in 2017 to over 40,000 in 2018, increasing tenfold since 2010, reported Dziennik Gazeta Prawna (pA5) on Tuesday.
Experts were hoping that the 2018 measles outbreak which reached Poland would convince anti-vaccination supporters to re-evaluate their beliefs, but unfortunately 2018 proved a record year for both vaccination refusals and new measles cases and this dangerous trend is continuing with 200 new patients already diagnosed with measles since the beginning of 2019.
Parents refusing to vaccinate their children could be repeatedly fined from 100 zlotys (€23) to 5,000 zlotys (€1,152) up to a maximum limit of 50,000 zlotys (€11,520). Meanwhile, the anti-vaccination lobby is making good use of legal experts and is taking the cases to courts, thereby effectively avoiding fines.
Celon Pharma’s depression treatment recommended by FDA
A new treatment for drug-resistant unipolar depression based on esketamine from Celon Pharma has been recommended for registration by the U.S. Food and Drug Administration based on the results of its clinical trials conducted by Johnson & Johnson, reported Parkiet Gazeta Gieldy (p5) on Thursday.
The treatment, which has now reached Phase II, may also prove itself as an off-label solution for patients without any more therapeutic options as well as those suffering from bipolar depression. Its inhalant method of administration has also proved to increase its deposition and therapeutic effects, without any serious adverse effects or formulation toxicity in patients.
The treatment will be one of Celon’s most rapidly developing treatments of the decade with a potential value of the tested esketamine-based drug estimated at $2.5 to 4 million.
Celon Pharma and Pure Biologics to receive substantial grants
Two Polish biotechs, Celon Pharma and Pure Biologics, will receive approximately 80 million zlotys (€18.4 million) in grants from the National Centre for Research and Development, reported Puls Biznesu (p6 & p7) on Thursday.
Pure Biologics is to receive 30.1 million zlotys (€6.9 million) on a 39.9 million (€9.2 million) project into the development of a cancer immunotherapy based on immunoligands and antibodies. Pure Biologics’ business is built around its antibody and aptamer libraries, which can be used to develop new drugs.
The company is already looking for the optimal antibody to use for this project and expects the pre-clinical trials to last until the end of 2021.
Celon Pharma will receive 24.7 million zlotys (€5.7 million) for its 39.8 million zloty (€9.2 million) project of developing a drug for use in various inflammatory diseases, such as psoriasis, rheumatoid arthritis and Crohn’s disease.
The company will conduct the pre-clinical trials and clinical evaluation during Phase I and Phase II. Celon Pharma’s second project applies to the development of an innovative PI3 delta kinases inhibitor for use in inflammatory diseases. The company will receive 24.5 million zlotys (€5.7 million) for this and the entire project is estimated at 38.9 million zlotys (€9 million).