WARSAW, 23 Aug (APM) - The Polish police and border guards will help pharmacy inspectors audit pharmacies participating in illegal drug exports, according to new amendments to the pharmacy law, reported Dziennik Gazeta Prawna (pB4) on Thursday.
This is a long-awaited change for the pharmacy inspectors, who were often left powerless against pharmacies that could simply refuse to let them into their premises.
The pharmacy inspectors can now order the pharmacy to be opened for inspection with the help of the police or the border guards. Neither of the forces will be allowed to refuse the request of the pharmacy inspectors and, if it proves unfounded, the cost of the intervention will be billed to the pharmaceutical inspectorate.
The Supreme Pharmaceutical Chamber is very pleased with the changes and hopes it will start increasing the rights of the pharmacy inspectors, who were often left defenceless against mafias illegally exporting drugs. The Chancellery of the Prime Minister has already proposed establishing a special pharma police similar to that used by the National Revenue Administration.
However, according to some groups, the use of a taskforce during pharmacy inspections can lead to the overuse of force and other remedies should be pursued to fight the problem instead.
300 drugs are currently under threat of illegal exports, representing 57% of all drug exports from Poland with the total annual value of illegal exports estimated at €458 million. Monthly wholesale revenue of medications declined by 40% after the announcement of inspections by the National Revenue Administration.
Only long-term strategic reforms can prevent future drugs' crisis in Poland
The main causes and long-term solutions for the Polish drugs' crisis were discussed in a debate between the Deputy Health Minister, members of the Supreme Pharmaceutical Council, pharma associations and pharma executives, reported Dziennik Gazeta Prawna (pB6-B7) on Tuesday.
Even after the peak of the drugs' crisis, more than 300 drugs are still hard to obtain on the Polish market. The long-term dependence on China for satisfying the needs for active ingredients is considered to be the cause of this situation. As the government forces Polish pharmas to reduce prices, pharma production is rarely profitable in Poland. Additionally, the low prices of Polish drugs give rise to illegal drug exports, which now represent 50% of Poland's total drug exports.
The experts emphasised the need for long-term rehabilitation policies to prevent such situations in the future. These include the reimbursement incentives system (RTR) awarding producers benefits for investing in the production of medications in Poland. Reforms are also needed in the reimbursement policy to increase the list of reimbursable drugs and enable the use of biosimilars at times of shortage of originator drugs.
The experts also emphasised that rules for obtaining medicines from wholesalers, which are fair to both individual and chain pharmacies, should be established urgently, while spending on drug reimbursement, which is currently 0.5% of GDP, should be increased.
Regulations simplifying formalities for clinical trials will be ready by year end
The Minister of Health is to establish a working party to prepare procedures and regulations simplifying formalities and shortening the time for the registration of clinical trials by the end of the year, reported Dziennik Gazeta Prawna (pB11) on Tuesday.
The working party is also expected to develop mechanisms supporting non-commercial trials and the operation of compensation systems and prepare regulations specifying the demarcation between the financing of healthcare benefits by the National Health Fund and the study sponsor, as well as the methods of financing the benefits required to qualify the patient for participation in clinical trials.
New therapies will increase quality of life of HIV patients
According to official statistics, Poland has approximately 24,000 HIV and 3,600 AIDS patients and, at the end of 2018, 11,000 patients, including 101 minors, were under the national antiretroviral (ARV) therapy programme, reports Gazeta Wyborcza (p24) on Friday.
There has been significant progress in HIV treatment as, patients were taking a "cocktail" of three different active ingredients to date together with drugs for other ailments, which often resulted in a large amount of drugs taken throughout their whole lives.
Scientists are now developing new treatments reducing the intake and dosages of drugs to increase the quality of life of these patients. The first treatment combining dolutegravir and rilpivirine in one tablet to be taken once a day was released in Europe in May 2018. Another treatment, combining dolutegravir and lamivudine was approved for the EU several weeks ago.
Pharmacists saved from higher fines for mistakes in prescriptions
The Ministry of Health (MoH) proposed new amendments to the prescription policies drastically increasing fines for mistakes in entering a patient's details into the system, not dispensing medicines and for failing to update information about pharmacy employees reported in Rzeczpospolita (pA15) on Tuesday, although these were strongly confronted by the pharmacy associations, leading to the MoH withdrawing from most of the changes, reports Rzeczpospolita (pA17) on Friday.
The fines, which were previously between 30 zlotys (€7) and 200 zlotys (€46), were to be increased to a fixed 600 zlotys (€138) plus a possible fine of 2% of the pharmacy's turnover over up to the previous 24 reimbursement cycles for failing to present accurate data on drug sales to the MoH.
The discussions between the deputy minister of health, Janusz Cieszyńsk and the president of the National Health Fund (NFZ), Adam Niedzielski, resulted in the withdrawal from the changes that were initially addressed to pharmacies that breach the reimbursement policies and were found to be too severe.
The only amendment that still worries the Supreme Pharmaceutical Council is the possible fine of 2% of the pharmacy's turnover, as this may result in disproportionate and long-term losses for the pharmacy for simple bookkeeping mistakes.
No-deal Brexit will lead to a severe drug crisis in UK
A recently-leaked report describing the consequences of a "no-deal Brexit", according to which all borders between the UK and the European Union will close on 1 November, shows that severe problems may arise with stocking up of UK pharmacies and hospitals with drugs and medicinal products due to obstructions in transfers of goods across the English Channel, reported Gazeta Wyborcza (p8) on Tuesday.
The report that was leaked to the Sunday Times states that three quarters of the drugs imported to the UK enter the country through Dover.
Bioton parts with insulin distributor for China
Harbin Gloria Pharmaceuticals, Bioton's insulin distribution partner on the Chinese market, has terminated the contract signed in September 2015, because of force majeure, reported Parkiet Gazeta Giełdy (p1, p6) and Puls Biznesu (p7) on Tuesday.
Harbin Gloria Pharmaceuticals was reported not to have achieved the agreed sales forecasts or minimum order quantities. Despite the separation, Bioton is still very interested in expanding in China reported both newspapers. It has also signed a cooperation agreement with Yifan Pharmaceuticals for producing and commercialising its insulin analogues reported Parkiet.
Pure Biologics' breast cancer R&D project received co-financing of €7 million
Pure BIKE, a treatment that is to use bispecific antibody fragments and recruit immunology cells to fight triple negative breast cancer researched by Pure Biologics, has received 29.9 million zlotys (€7 million) from the Polish National Centre for Research and Development, reported Parkiet Gazeta Giełdy (p7) on Wednesday.
The R&D project will be conducted between 2019 and 2023 and its cost is estimated at 40.4 million zlotych (€9.3 million). PureBIKE is the company's third drug project and, according to Dr Filip Jeleń, president of Pure Biologics, the company plans to start one or two more projects in the coming quarters.