WARSAW, 22 Feb (APM) - Plans to introduce harsher penalties in Poland for illegal drug exports could be delayed due to EU bureaucracy, reported Rzeczpospolita (pA15) on Tuesday.
The Ministry of Foreign Affairs told the Ministry of Justice that the amendment to the Pharmaceutical Law cannot be passed and take effect without a technical notice being sent to the EU for the additional regulations on online sales of prescription drugs for the disabled, which are being processed under the regulations intended to curb illegal parallel drug exports.
According to the new regulations, anyone involved in illegal exports, which are currently estimated at 2 billion zlotys (€460 million) a year, could face up to 10 years’ imprisonment.
A legal expert specialising in the EU pharmaceutical law, Grzegorz Rychwalski, said the entire procedure could take anywhere between six weeks and two years.
Additional patent protection for originator drugs outside EU will be lifted
The EU has decided to lift the additional five-year patent protection period for originator drugs via the SPC certificate after the standard 20 years to allow competitors to sell generics outside the EU, reported Rzeczpospolita (pA21) on Monday.
The SPC certificate is only valid within the EU and prevents European producers of generics from selling their products even outside the EU.
According to the new regulations, the additional five-year period will not apply to drugs exported outside the EU, while generics producers will be able to start producing and storing their equivalents that are to be sold within the EU six months before the SPC certificate expires.
The EU officials believe the new opportunities will help create 25,000 new jobs within 10 years. The new regulations are to enable European generics producers to be competitive with respect to the U.S. or Asian companies not affected by the SPC certificate on non-EU markets.
While several member states, including Denmark, Sweden and the UK, objected to the new regulations, the European Parliament had the final say. The changes coincide with the U.S. Food and Drug Administration’s decision to grant Poland a Mutual Recognition Agreement (MRA), which means that Polish drugs can be launched in the U.S. without completing individual registration procedures. This makes Poland the 22nd EU member state with the MRA and will enable Polish generics producers to expand further.
Total pharma production in Poland was 13 billion zlotys (€3 billion) in 2017, which was 7.5% higher by value than in 2016.
Local authorities invest in HPV prophylaxis
An increasing number of local authorities are starting to finance prophylactic HPV vaccinations, which would otherwise not be covered by the state, reported Dziennik Gazeta Prawna (pA5) on Tuesday.
Although local authorities were focusing on securing financing for pneumococci vaccinations in previous years, after they were included in the obligatory vaccination schedule, the authorities decided to shift the funds to HPV programmes.
Such a programme has already been confirmed in Warsaw, where 14,000 12-year-olds will be eligible to receive the vaccine free of charge. Similar initiatives were announced in Cracow, Gdansk and Olsztyn, while some cities have been financing such vaccinations for years.
Health ministry could introduce obligatory HPV vaccinations
The Ministry of Health is considering adding HPV vaccinations to the mandatory vaccination schedule, reported Dziennik Gazeta Prawna (pA4) on Wednesday.
Experts say that, despite the high cost of free vaccines, their long-term effects would bring savings for the system. HPV vaccines cost around 300 zlotys (€69) per dose, while 400,000 children who are eligible each year would need two to three doses.
While HPV vaccinations are recommended in Poland, they have only been financed by some local authorities. Poland is still one of the countries in which HPV-related cervical cancer is deadly, with eight out of 100,000 women dying from the disease, which is four times more than in Scandinavia and 74% more than the EU average for the group of patients aged between 25 and 65.
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 Gazeta Wyborcza (p7) on Tuesday.
The entire stock of medical cannabis was bought out by roughly 300 patients. While the drug can be prescribed by all doctors, most prescriptions were written out by specialists who had already used cannabis-based therapies in the past. Patients are usually prescribed a monthly dose, which translates into 10-15 grams of dried product, priced at 65-70 zlotys (€ 14.9-16.1) per gram, which then needs to be inhaled.
A Polish expert on cannabis-based therapies, Jerzy Jarosz, claims the currently available dried cannabis containing 19% THC and 1% CBD is primarily useful in pain treatment, while patients need access to more types of such products with varying levels of THC and CBD.
Spectrum Cannabis, the only licensed importer of medical cannabis in Poland, is planning to file an application with the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products to register another variety of the product by the end of the week, which could be used for in multiple sclerosis treatment, as well as for treating adverse effects of chemotherapy or radiotherapy. However, the officials will have up to 200 days to issue their decision.
Spectrum Cannabis says future deliveries of medical cannabis will be larger, with up to 15-20 kilograms being planned by the end of February, 50 kilograms in March and around 100 kilograms per month by the end of the year.
New regulations on setting up Medical Research Agency
Officials are continuing their work on the regulations on establishing the Medical Research Agency (ABM), reported Dziennik Gazeta Prawna (pB11) on Wednesday.
The ABM is planned to support the development of Polish medicine, primarily through the organisation of non-commercial clinical trials. The ABM will primarily be financed by the state, but the National Health Fund (NHF) will support it with 0.3% of its budget. The ABM will be able to provide funding for institutions involved in R&D activities, while its budget will increase from 50 million zlotys (€11.6 million) in the first year to 1 billion zlotys (€231 million) within ten years.
Bartosz Arlukowicz, a former health minister from the PO (Civic Platform) party, said there is no need for yet another agency, while additional strain on the NHF’s budget is unacceptable, especially as the system is already plagued by long waiting times.
The Ministry of Health claims that although some of the ABM’s budget will he financed by the NHF, the money will return to patients in the form of access to additional clinical trials. The officials also say they will ensure the ABM is properly managed by highly qualified experts selected via an appropriate selection process.
Official commentary on Medical Research Agency
Health minister Lukasz Szumowski and Radoslaw Sierpinski, who is responsible for establishing the Medical Research Agency (ABM), claim the new institution will pave the way for domestic biotechs to launch innovative drugs, reports Dziennik Gazeta Prawna (A23) on Friday.
The officials claim the Polish clinical trials market, currently estimated at 1.5 billion zlotys (€346 million), should be twice as large, considering its potential and comparing the available data with western countries.
They say the experiences of equivalent institutions from the UK and the U.S. show it is well worth investing in the biotech sector, as spending on innovative drugs, non-drug technologies and biotechnology in general brings a fourfold return on investment within several years.
The ABM is also planning to serve as a partner in international debates and an important institution at the heart of the Polish healthcare system, focusing on giving access to innovative therapies for Polish patients, as well as helping scientists to continue the development of their products after Phase I or II and eventually commercialising them.
Poland could become biotech hub
With the global biotech industry rapidly growing, Poland could become the next hub for this sector, with its large scientific and research potential, reported Dziennik Gazeta Prawna (pA22 & pA23) on Friday.
The important factors increasing the probability of such a scenario are the presence of highly qualified specialists, large international players operating on the market, government initiatives focused on developing the biotech industry and high education standards.
An increasing number of major players, such as Pfizer, Amgen Ventures and Johnson & Johnson Innovation admit they are interested in supporting the biomedical ecosystem in Poland, while others, such as Roche and AstraZeneca have already invested in their own R&D centres.
Finally, there are also domestic biotechs with very high potential, such as Selvita, and 250 other companies operating in the sector, employing 12,000 people and investing over 1 billion zlotys (€231 million) in R&D per year.
'Chaos' in Ministry of Health
Rumours of chaos and malpractice within the Ministry of Health (MoH) are spreading because of a lack of management meetings, which were discontinued by health minister Lukasz Szumowski two weeks ago, reported Gazeta Wyborcza (p7) on Friday.
Apart from the fact that the everyday work of the officials has been disturbed and the decision-making process is no longer transparent, there are other concerns, such as appropriate reimbursement document flow and safety standards.
One example applied to a case in which a National Health Fund employee collecting a data storage device with reimbursement decisions and confidential drug prices from the MoH, did not present a permit or leave a receipt.
Another case applied to the former deputy health minister responsible for drug policy, Marcin Czech, continuing to have access to the reimbursement list IT system, which allowed him to review confidential reimbursement applications of pharma companies.
Innovative method of administering insulin
Scientists from the Massachusetts Institute of Technology in the U.S. have developed a more convenient way of administering insulin to type-2 diabetes patients, reported Rzeczpospolita (pA11) on Tuesday.
The method involves oral administration of a capsule containing a small needle composed of freeze-dried insulin, which automatically injects itself upon reaching the stomach.
The rest of the capsule is made of a biodegradable polymer and stainless steel elements which are naturally secreted through the digestive system. The entire process is painless and, according to preliminary tests on animals, is as effective as traditional subdermal insulin injections performed by type-2 diabetes patients.
The scientists are developing their method in cooperation with Novo Nordisk and believe it could be used in all therapies involving protein-based drugs that need to be injected.