Press review

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New regulations on drug production and distribution in Poland

Country : Czech Republic, Hungary, Poland

Keywords :
WARSAW, 23 Mar (APM) - The Polish government accepted an amendment to the Pharmaceutical Law on Tuesday, whereby supervision over pharma manufacturing and distributing will be increased, reported Dziennik Gazeta Prawna (pB11) on Wednesday.
The amendment brings the Polish regulations closer to the EU directives and primarily applies to medicinal products used in advanced hospital therapies, the production of which requires a licence from the Chief Pharmaceutical Inspectorate (GIF).
Additionally, the new regulations introduce new mechanisms ensuring that there will be no conflicts of interest within the GIF, as pharmaceutical inspectors will no longer be allowed to have any connections with entities they could potentially be auditing. Furthermore, the regulations improve supervision over drug exports to prevent illegal activities.
An entity will no longer be allowed to simultaneously operate an outpatient clinic and a wholesaling businesses, which is popular practice among companies involved in illegal drug exports. Finally, the amendment adapts the Polish regulations on clinical trials to EU standards.
The amendment is to take affect 14 days after its announcement.

Officials confirm existence of drug exporting mafia

The Minister of Justice, Zbigniew Ziobro, openly claimed on Wednesday that there is a drug exporting mafia which is responsible for drug shortages in Polish pharmacies and announced that the officials will take a more radical approach to counter the problem, reported Dziennik Gazeta Prawna (pB6) on Thursday.
The officials announced that the current system of fines is ineffective and that, despite having such a possibility, pharmaceutical inspectors have failed to fine a single entity for such activities.
The deputy minister of justice, Marcin Warchol, said the individuals involved in illegal drug exports will now be punishable with 10 years’ imprisonment and extremely high fines, while the system of monitoring pharmacies, wholesalers and outpatient clinics will be substantially tightened. Companies will also be required to fully cooperate with pharmaceutical inspectors and other law enforcement agencies, such as the Internal Security Agency, will not be allowed to refuse to become involved, claiming that fighting illegal drug exports is not their responsibility.
Marek Tomkow, deputy president of the Supreme Pharmaceutical Council, believes the proposed changes are necessary and should help curb the problem of illegal drug exports, even though they might seems radical.
The value of illegal drug exports in Poland is estimated at 1.5-2 billion zlotys (€355-473 million) per year causing a restriction of access to around 200 health- and life-saving drugs in pharmacies.

Positive outlook for Polish pharma market

According to QuintilesIMS, the Polish pharma market reached 38.3 billion zlotys (€9.1 billion) in 2017, which was a 4.9% increase over 2016, and should continue to increase rapidly in the coming years reported Rzeczpospolita (pA23) on Wednesday.
One of the reasons for the growth includes the ageing of society, as the percentage of patients aged over 60 will increase to 30% in 2030, compared with 19% in 2014. While the mayor big global players, such as Sanofi, Teva, GlaxoSmithKline, Roche, Pfizer and Merck are present and strong in Poland, the majority of the market is controlled by the domestic generics manufacturer, Polpharma, with 600 products in its portfolio and 200 in the R&D pipeline.
This is reflected in the market structure, as the share by volume of generics is 85%, while the share by value is 60%, which can be attributed to the fact that generics in Poland are among the cheapest in the EU.
However, the domestic biotech market is growing rapidly, with many Polish companies having aspirations to develop their own innovative drugs. The majority of serious health issues in Poland are cardiovascular diseases, cancer, pulmonary diseases, mental diseases and diabetes. 45% of fatalities are caused by cardiovascular diseases and cancer, mostly lung cancer and bowel cancer in men, and lung cancer and breast cancer in women.
In terms of drug distribution, Neuca, Farmacol and Polska Grupa Farmaceutyczna from the Pelion group control 70-80% of the market. The largest is Neuca, with a market share of 30%, revenues of 7.5 billion zlotys (€1.8 billion) and a net profit of 99 million zlotys (€23.4 million) reported in 2017, even though, unlike Pelion, the company does not have its own pharmacy chain.

EU wants to decide on drug reimbursement

Polish Pharma companies are concerned that the EU Commission wants to start making decisions about drug reimbursement in Poland, reported Rzeczpospolita (pA15) on Tuesday.
While currently every member state conducts clinical analyses of drugs individually, according to the new regulations being forced through by the EU, such analyses for the most innovative drugs would be conducted centrally by the EU. Grzegorz Rachwalski, vice president of the Polish Association of Pharma Industry Employers claims this could be the first step towards enabling the EU to take control over the entire reimbursement process in the EU, which would have an adverse impact on the Polish healthcare budget.
However, legal experts are less sceptical and say there are no grounds for drawing such conclusions and that streamlining the process of conducting clinical analyses of drugs could be a desirable change for the entire system. Natalia Lojko from the KRK Kieszkowka Rutkowska Kolasinski law firm said the EU proposal puts order to drug assessment, respects the privacy of pharma companies in terms of reimbursement applications and guarantees full transparency in terms of medical technology assessment due to the inclusion of experts and patients in the process.
Magdalena Wladysiuk, president of the Central and Eastern European Society of Technology Assessment in Health Care and vice president of HTA Consulting, said that, although the EU regulations are consistent with the requests of pharmas to streamline the standards of medical technology assessment for years, it could, in fact, tie the hands of the health minister.
According to the newspaper, the Ministry of Health has similar concerns, as Polish pharmas and officials will recommend giving the health minister more leeway.

New regulations on clinical trials

According to the amendment to the Pharmaceutical Law, it will be easier for pharma companies to conduct clinical trials in Poland, which should improve access to them for Polish patients, reported Rzeczpospolita (pA17) on Wednesday.
Pharma companies will no longer be required to provide copies of all contracts signed with researchers and medical institutions which are to be involved in the clinical trials to the registration office. Instead, the companies will only file a description of the financing and fees for patients, researchers and medical institutions, which significantly reduces the amount of bureaucracy in the process.
Legal experts say these changes should improve access to clinical trials of innovative drugs in Poland, as foreign companies will no longer be discouraged by the overly complicated process, which requires a greater effort than in most other EU member states.
According to the PwC report, the number of clinical trials per capita conducted in Poland in 2014 was over 50% lower than in the Czech Republic and Hungary. Although the value of the clinical trials market in Poland increased by 15% to 950 million zlotys (€224.6 million) between 2009 and 2014, foreign companies have been more inclined to choose other countries and analysts believe the sole reason for this was bureaucracy, even though Polish scientists are considered to be extremely competent.

Pain treatment will be improved

The officials are working on new, improved pain treatment standards that will grant access to such treatment for all patients, reported Dziennik Gazeta Prawna (pB1) on Thursday.
According to the regulations, doctors will be required to assess and monitor pain levels in patients, while patients will be able to file complaints with the Patients’ Ombudsman. Access to more potent, opioid analgesics should also be improved, as the standards for pain treatment will be brought closer to current global practices.
Experts agree that these changes should significantly improve the quality of life of all patients receiving treatment, including those suffering from chronic pain.
According to estimates, up to 20% of Poles suffer from chronic pain while patients do not have access to free consultations with specialists qualified in pain treatment in 70% of all Polish counties.

Emergency access to drug technologies is restricted

Doctors and experts warn that emergency access to drug technologies (RDTL) is restricted because of bureaucracy and settlements with the national health fund (NHF), reported Dziennik Gazeta Prawna (pA2) on Wednesday.
According to the regulations, access to RDTL may be granted to patients suffering from the most dangerous diseases after exhausting all other options.
However, the procedure is time-consuming and complicated, as the hospital must file the application with the regional health consultant and doctors are generally unwilling to fill out the forms, especially as the chances of being granted RDTL are very low.
Furthermore, hospital management is also reluctant to file applications, because the NHF requires hospitals to cover the often extremely high cost of therapy within their contracts and there is no guarantee that the costs will be fully covered in the next round of financing.

Anti-vaccination lobbies want vaccinations to be voluntary

The STOP NOP anti-vaccination organisation wants vaccinations in Poland to be voluntary, as in the case of 19 other EU member states, reported Rzeczpospolita (pA17) on Thursday.
STOP NOP prepared a bill stating that the regulations would be less restrictive and vaccinations would no longer be mandatory unless the officials announce an epidemic risk alert or state of epidemic. Additionally, the regulations would enable patients or their legal representatives to file complication reports directly with the local sanitary inspectorates, which would be in compliance with the EU directives.
Such reports can currently be filed by doctors and STOP NOP claims that, in most cases doctors do not want to risk incriminating themselves. Furthermore, doctors would be obliged to inform patients about all potential complications that could arise from vaccinations and conduct a detailed survey with patients afterwards.
STOP NOP also criticises the fact that Poland is the only EU member state with obligatory vaccinations without having a proper compensation system in case of complications.
In addition, there is a lack of supervision of the complications register run by the Chief Sanitary Inspectorate and many cases of serious complications are supposedly reported as mild cases.
According to STOP NOP, all of this is resulting in a rapidly growing number of parents refusing to vaccinate their children. The number of such cases increased from 12,600 in 2014 to over 30,000 in 2017 and STOP NOP points out that the deficiencies of the system are also acknowledged by the courts, as there has not been a single ruling to date in which parental rights of parents refusing to vaccinate their children were restricted.

Number of measles cases rising rapidly

The Chief Sanitary Inspectorate warns that the number of measles cases in Europe and Poland is growing rapidly, reported Gazeta Wyborcza (p3) on Thursday.
The problem is pressing, as increasingly more parents refuse to vaccinate their children. Although the percentage of vaccinated children is still above the 95% mark, Poland has seen 30 cases of measles this year until 15 March, compared with 60 cases throughout 2017.
The number of measles cases in Europe increased fourfold between 2016 and 2017, reaching 21,000 cases, of which 35 were fatal.

Doctors do not want to specify reimbursement discount

Although doctors claim they should not be responsible for specifying the reimbursement discount on prescriptions, legal experts suggest they should be supported instead of facing fines for mistakes, reported Rzeczpospolita (pA18) on Monday.
Doctors say the need to specify the reimbursement discount takes too much of their time, especially since the reimbursement list changes so often. However, doctors are also being fined for their mistakes and, in 2016, they had to refund 9.4 million zlotys (€2.2 million) to the national health fund as a result of 450 audits.
However, Natalia Lojko, a legal expert from the Kieszkowska Rutkowska Kolasinski law firm, says only doctors have sufficient knowledge and ability to determine what the reimbursement discount should be, but the officials should consider eliminating or reducing the fines for mistakes and provide some administrative support to the doctors to make the process less cumbersome.

OncoArendi Therapeutics plans to float

Polish biotech, OncoArendi Therapeutics, specialising in drugs for inflammatory diseases and cancer, intends to collect up to 66 million zlotys (€15.6 million) from its initial public offering, reported Parkiet Gazeta Gieldy (p3) on Saturday and Rzeczpospolita (pA22) and Puls Biznesu (p18) on Monday.
90% of the shares are to be sold to institutional investors and although the company does not generate any revenues, its capitalisation after the IPO could reach over 450 million zlotys (€106.1 million). OncoArendi’s business model is based on the assumption that the company will be selling rights to prospective drug candidates to larger pharmas after reaching at least phase II, reported all the newspapers.
The money from investors will be used to continue Phase I of the company’s innovative chitinase inhibitor, OATD-01, for treating asthma, idiopathic pulmonary fibrosis or sarcoidosis, and to develop two arginase inhibitors for cancer immunotherapy and, again, idiopathic pulmonary fibrosis. The development cost of the two latter drugs is estimated at 44.5 million zlotys (€10.5 million), of which 18 million zlotys (€4.2 million) would be covered by the funds from the IPO, reported all the newspapers.
Stanislaw Pikul, member of the OncoArendi’s board, said OATD-01 has already been administered to 48 volunteers and no side-effects were reported, which shows the drug is safe, reported Parkiet and Rzeczpospolita. Pikul added that phase I for OATD-01 should last 18 more months, while trials for OATD-02 should begin in mid-2019, reported Parkiet.

Neuca came close to meeting its 2017 targets

Neuca, Poland’s largest pharma wholesaler, achieved 99% of its net profit target for 2017, which satisfied investors, reported Parkiet Gazeta Gieldy (p3) on Saturday.
Neuca reported a net profit of 99 million zlotys (€23.4 million) in 2017 and, after this announcement, the company’s share price on 16 March soared by 6.8%, to 266 zlotys (€63). The wholesaler also increased its revenues by 5.8%, to 7.5 billion zlotys (€1.77 billion), compared with 2016.
Piotr Sucharski, Neuca CEO, said the company intends to invest 100 million zlotys (€23.6 million) in a new logistics centre in Torun in 2018, additional outpatient clinics, telemedicine services and clinical trials.
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