Press review

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New counterfeit drug regulations could paralyse sales in Polish pharmacies

WARSAW, 8 Feb (APM) - Although the system for checking the authenticity of prescription drugs is being launched in Polish pharmacies on 9 February, there is a major risk that its implementation is incomplete and could result in chaos, reports Dziennik Gazeta Prawna (pC1-C5) on Friday.
The entity responsible for setting up and launching the system is the Polish Medicines Verification Organisation (KOWAL).
The problem is that not all drugs will be initially recognised by the system and not all pharmacies are connected to it, as some have not even received their access codes from KOWAL. While it appears that the system is not ready for its planned launch and industry experts fear the situation could have an adverse effect on patients, the officials claim the concerns are unfounded.
The biggest concern is that some pharmacies will refuse to dispense drugs identified by the system as counterfeit only because the system does not recognise them, even though they may not be counterfeit at all.
Some pharmacists are also worried that the officials will start fining them for not using the system, regardless of the reasons. The Chief Pharmaceutical Inspectorate (GIF) says all the entities involved have been aware of the 9 February deadline for over three years, when the EU directive on the matter took effect.
The GIF added that the additional Polish regulations supplementing the EU directive will not enter into force before 9 February despite previous plans, which means that the pharmacies will not initially be fined for dispensing any drugs they have in stock.
The regulations are also criticised by some pharma wholesalers, as those who are not directly related to pharma manufacturers will be required to scan and check the authenticity of all prescription drugs they have in stock.
Estimates suggest 40% of all drugs in pharmacies could be initially identified as counterfeit and 30% of all pharmacies may not be ready to use the system.
An estimated 1% of drugs sold in Polish pharmacies and 50% of drugs bought online by Poles could be counterfeit, which translates to 300 million zlotys (€69.8 million) spent on such products each year.

Price increases of reimbursable drugs

Natalia Lojko from KRK Kieszkowska Rutkowska Kolasinski law firm said many controversies around the increase in official reimbursable prices accepted by the former health minister are unfounded, reports Rzeczpospolita (pA17) on Friday.
Lojko said the procedure for increasing prices is specified in detail by the Reimbursement Act and involves not only the health minister, but also a special committee, representatives of the National Health Fund and sometimes the HTA Agency.
She added that the official prices seen by the public and published by the health minister do not include special, classified agreements with pharma companies, which is why the actual prices paid by the state for drugs may often be lower. This allows for lower spending, without putting pharmas at a disadvantage when negotiating prices in other countries in the region.
She also pointed out that such a solution is often necessary to ensure continued access to drugs for patients and that similar steps have been taken since the introduction of the Reimbursement Act in 2012 by previous health ministers.

Reimbursement level for prescription drugs will be set by the system

The Ministry of Health wants to relieve doctors from their duty of specifying the reimbursement level for prescription drugs, reported Rzeczpospolita on Wednesday (pA17) and Thursday (pA17).
The officials want the reimbursement level to be specified automatically by the e-prescription system based on the EAN codes of drugs, thereby giving doctors more time to focus on treating patients. The regulations may be announced by the end of February.
Up to the end of January, 190,000 prescriptions were made out through the e-prescription system, and, while only 102 healthcare institutions from 73 cities have so far implemented it, their number is rapidly increasing.

Free HPV vaccinations for teenagers in Warsaw

Warsaw’s local authorities decided to reimburse HPV vaccinations for all 12-year-olds from mid-2019, reported Gazeta Wyborcza (Stołeczena supplement, p1) on Thursday.
Around 15,000 children will be eligible to receive the vaccine and the city will spend 5 million zlotys (€1.2 million) a year on the programme. HPV vaccines can be bought in pharmacies, but cost 300-400 zlotys (€70-93) while patients require two doses. Similar programmes are already co-financed by over 200 local authorities throughout Poland.

Medical cannabis could be cheaper

An unfavourable VAT ruling causes patients to overpay for medical cannabis in pharmacies, reported Rzeczpospolita (pA13) on Tuesday.
When the only importer of medical cannabis, Spectrum Cannabis, was launching the product onto the market, the Central Statistical Office stated that it was subject to 23% VAT instead of 8%, as with other pharmaceutical raw materials.
This decision is being contested by the company and pharmacists and means patients have to pay around 65 zlotys (€15.1) for the product instead of around 55 zlotys (€12.8) in pharmacies.
Furthermore, medical cannabis is not reimbursed and patients currently only have access to dried cannabis sativa flos, containing 19% THC and 1% CBD, although Spectrum Cannabis intends to supplement its range with THC and CBD oils in the future, provided it receives authorisation.
Spectrum has already asked the tax administration for another ruling and hopes it will receive an amended decision before another batch of medical cannabis is imported to Poland.

Valsartan and cancer risk

The European Medicines Agency claims 30 out of 100,000 patients using drugs containing contaminated valsartan from China in the maximum dosage will develop cancer, reported Dziennik Gazeta Prawna (pA16) on Tuesday.
The contamination primarily applies to popular high blood pressure drugs taken in Poland by several hundred thousand patients. However, most of them did not take the maximum dose.
It was discovered in late June 2018 that a large number of drugs containing valsartan produced in one Chinese factory also contained dangerous, carcinogenic NDMA and NDEA chemicals. Around 50 such drugs sold by a dozen or so companies were recalled from the market in Poland.
Professor Zbigniew Fijalek from the Medical University of Warsaw claims the entire situation undermines the credibility of the drug safety supervision system and pharma companies. He added that, not long after the valsartan case, similar contamination was found in other factories, and applied to candesartan, irbesartan, losartan and olmesartan, which resulted in the Chief Pharmaceutical Inspectorate recalling more drugs from the market.
The EMA recently ordered pharma companies producing drugs containing sartans to thoroughly review their manufacturing processes over the coming two years to prevent similar situations from arising in the future.

Additional patent protection for originator drugs could be lifted outside EU

The European Parliament’s Committee on Legal Affairs supports lifting the additional five-year patent protection period for originator drugs via the SPC certificate after the standard 20-year patent protection period to allow competitors to sell generics outside the EU, reported Rzeczpospolita (pA17) on Thursday.
The SPC certificate is only valid within the EU and prevents European producers of generics from selling their products, even outside the EU.
Lifting the export ban could be a major opportunity for generics' producers to improve their competitiveness on global markets and reduce drug prices for patients. Furthermore, the Commission supports the production and storage of generics and biosimilars before the expiry of the SPC certificate, which would enable competitors to start selling their products immediately after the additional patent protection expires.
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