Press review

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Hard Brexit may exacerbate Poland’s drug shortage crisis

WARSAW, 9 Aug (APM) - In the preparations for Brexit, the UK is buying out huge quantities of Chinese active pharmaceutical ingredients (API) and drugs from EU countries - a fact which could contribute to future drug shortage crises in Poland.
This is according to reports carried by Rzeczpospolita (pA14) on Monday and Dziennik Gazeta Prawna (pB4) on Wednesday.
The UK is ordering vast quantities of APIs for producing drugs for diabetes, thyroid gland, cardio and neurological diseases from Chinese producers, they noted. It is also offering higher rates for reserve drugs from producers in the European Union to increase their supply to last at least six weeks without any new orders, reported Dziennik Gazeta Prawda.
It is part of the UK's plan to maintain a strong position in future pharma negotiations, as well as to have sufficient reserves for UK residents.
Experts say this situation could contribute to future drug shortage crises in Poland, as 80% of APIs used in Polish products are imported from China. Since the UK is buying the ingredients for higher prices, it will now be the first to receive them, according to the reports. Systems supporting local drug production need to be implemented to prevent future drug shortages, added Dziennik Gazeta Prawna.
According to Michał Byliniak, president of the Pharmaceutical Group of the European Union (PGEU), it should not be economic reasons but the patient’s well-being that is the first to determine drug availability.
Numerous pharmacists have reported that wholesalers are refusing to accept orders for drugs that are in short supply, while they simultaneously appeared in larger pharmacy chains. Such a situation is especially severe for Polish patients from rural areas, who often cannot visit several pharmacies because of the large distances they would need to travel, reported Rzeczpospolita.
During the peak of the drug crisis, Polish pharmacies had shortages of around 500 drugs used for treating diabetes, thyroid, cardiological, ophthalmological, oncological and neurological diseases. The illegal export list includes 324 drugs, while around 800 drugs made in Poland are actually produced by UK companies, reported Dziennik Gazeta Prawna.

Poland will introduce cross-border e-prescriptions

According to amendments to Poland's legislation on e-healthcare, patients with e-prescriptions will be able to purchase their medications from any pharmacy within the European Union by 2021, reported Rzeczpospolita (pA13) on Monday.
The amendments will also allow patients on long-term medication and those taking medicines where there are no harmful adverse effects to have e-prescriptions valid for a year.
Patients would then buy their medications in batches as they need them, without having to go to a doctor for a new prescription every few months. Poland has been included in European Union’s wave-3 of the implementation of this system.
This means that the e-prescription will also operate outside Poland from 2021, which represents a big change to the current system, in which only paper prescriptions are accepted. Such paper prescriptions also create difficulties for foreign pharmacists to check their authenticity.
The amendment will also enable specialists - not just general practitioners - to write out prescriptions for fully reimbursable drugs for patients aged over 75, which will shorten the procedure for patients, especially after surgery or after hospital treatment, as they will not need to visit GPs to receive their prescriptions after their appointments with a specialist.
Additionally, as the reimbursement rates of the drugs will be specified by the electronic system, doctors will be exempted from liability of specifying the wrong reimbursement rates. The amendment will also allow medical assistants to issue, complete and sign medical documentation, e-prescriptions and e-referrals on behalf of doctors.

Polish health specialists call for better access to innovative cardiovascular drugs

The Ministry of Health will test a pilot programme known as KONS for comprehensive care of patients suffering from cardiac insufficiency (heart failure), but specialists are calling for better reimbursement of innovative cardiac drugs to fight increasing disease rates, reported Rzeczpospolita (pA10, pA11) on Wednesday.
Poland has between 700,000 and one million heart failure patients and, according to specialists, the ageing population will increase this number. Despite cardiac diseases being effectively treated in Polish hospitals, patients very often return to hospitals in a much worse condition after several years, through insufficient post-hospitalisation care.
This was the reason for creating KONS, which will take care of the well-being of patients, and which, according to experts, will provide huge savings for the Polish National Health Fund (NHF) by reducing hospitalisation costs.
Nevertheless, experts not only want more innovative, but also more expensive, drugs to be added to the reimbursement lists, such as sacubitril/valsartan, which has proved effective during the PARADIGM-HF and PIONEER-HF trials and is claimed to reduce the rate of both hospitalisations and deaths caused by cardiac insufficiency by 30-40%. The drug is reimbursable in most EU countries.

Poland's reimbursement incentives system (RTR) criticised by industry

Poland's Ministry for Entrepreneurship and Technology's regulations on the reimbursement incentives system (RTR), presented in in mid-July, is facing criticism from the pharma sector, Puls Biznesu (p8) reported on Friday.
The long-awaited RTR is intended to promote and financially support investments in R&D and the production of medications for companies that have the best positive impact on the Polish economy.
Such companies would compete for the status of Partner of the Polish Economy (PPG) through their positive influence on the Polish pharma industry and investments in talents, R&D work and data analysis. PPGs would be ranked according to a complex scoring system and would receive a share of the support budget that reflects their position in the ranking. The annual assumed budget for the programme of 400 million zlotys (€93 million) would be co-funded equally by the NHF and the Medical Research Agency (ABM).
But though pharma was eagerly awaiting regulation, the Employers' Union of Innovative Pharmaceutical Companies INFARMA - associating large, international players, such as Novartis, AstraZeneca, GlaxosmithKline, Sanofi, Roche and Pfizer - said the proposal raises numerous concerns.
Firstly, the group is worried about the RTR being co-financed by the NHF, arguing it means less money for reimbursement within an underfinanced Polish healthcare system having a total budget of 4.86% of GDP compared with the 6.8% EU average.
Another point raised by INFARMA is that the benefits offered to pharma companies within the current RTR proposal could be classified by the EU as prohibited state aid.
The programme was already criticised in July by the Polish Union of Pharmaceutical Industry Employers for not presenting the specific goals of the initiative and delays in legislative work.
It is already certain that the officials will not be able to introduce the RTR regulations before the forthcoming parliamentary elections.

Polish Catholic pharmacists want to reinforce the 'conscience clause'

Polish Federation of Catholic Pharmacists (SFKP) wants to reinforce the wording of the conscience clause to add the possibility of refusing to provide a medication if it is in conflict with their conscience, providing that it does not endanger the patient’s health or life, reported Rzeczpospolita (pA14) on Wednesday.
Marek Tomków, president of the Supreme Pharmaceutical Council, says the problem needs to be carefully considered, as many drugs that might be controversial are prescribed for treating various illnesses. If such a clause were to be amended due to religious motives it should be also discussed with the non-Catholic representatives, added Tomków.

Interview with the acting president of the Medical Research Agency (ABM)

Dziennik Gazeta Prawna published an interview with the acting president of the Medical Research Agency (ABM), Radoslaw Sierpinski, on the institution’s primary objectives and plans on Thursday (pB9).
Sierpinski said it is important to increase the ratio of non-commercial clinical trials in Poland from the current 1% to at least 10% within five years, ultimately aiming to reach the 30% goal achieved in Western Europe. The ABM will initially have a budget of 200 million zlotys (€46 million) in 2020 for clinical trials, which is to increase to 500 million zlotys (€116 million) in the future. These funds will be distributed among scientists through tenders, with the first tenders due to start by the end of this year.
The financing priorities will be set by the health minister, but Sierpinski said there are areas which certainly need help, such as paediatric haemato-oncology, oncology in general, rare and cardiovascular diseases. Grants will primarily be provided to public entities, such as clinical hospitals or medical universities, but it will be important to create public-private partnerships.
While 80% of the resources will be allocated through external grants, the ABM also wants to run its own projects with the help of external institutions, universities and individual scientists. Sierpinski is not concerned about the fact that the NHF will be co-financing its activity, as the money will return to the patients in the form of health benefits, thereby improving access to innovative treatment. The ABM wants to work closely with its international counterparts, which could create new partnerships facilitating access to additional therapies for Polish patients.
Sierpinski is also not worried that the ABM’s activities will overlap with those of other institutions already operating in Poland, such as the HTA agency or the National Centre for Research and Development, as the ABM’s role will be much more focused on finalising the delivery of new therapies to the market due to its higher budget and specialisation.
The officials are currently working on new clinical trials regulations to reduce the amount of bureaucracy, increase patient safety and streamline the entire process, which will involve both the ABM and the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products.
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