WARSAW, 8 June (APM) - Poland's justice ministry (MoJ) has been preparing new regulations to severely penalise all activities involving illegal exports of medications, reported Rzeczpospolita (pA15) on Wednesday, while legal experts say the regulations have numerous alarming loopholes, reported Dziennik Gazeta Prawna (pA1 & B1) on Thursday
According to the new regulations, anyone involved in illegal sales, transportation or storage of drugs could face three to five years’ imprisonment, or up to eight years if these activities are conducted on a larger scale.
Additionally, anyone obstructing pharmaceutical inspectors in their tasks could face up to three years’ imprisonment, while pharmacists and wholesalers could face up to two years’ imprisonment for attempting to cover up their illegal activities. Also, companies refusing to cooperate with the Chief Pharmaceutical Inspectorate could be fined up to 300,000 zlotys (€70,093), reported Rzeczpospolita.
However, Marek Tomkow, president of the Supreme Pharmaceutical Council, said that while the MoJ wanted to enable pharmacists to donate drugs to hospices, orphanages or victims of natural disasters free of charge, the regulations were badly phrased and, in their current form, they actually enable pharmacists to hand out prescription drugs to individuals without prescriptions for free or at prices other than those specified in the reimbursement list. Tomkow believes this could open up an entirely new avenue for drug export mafias instead of curbing the problem, reported Dziennik Gazeta Prawna.
The MoJ completely disagrees with Tomkow’s interpretation of the regulations, but admitted they should be more precise. Meanwhile, individual pharmacists are concerned about the regulations, as, in their current shape they could enable further expansion of pharmacy chains and aggressive promotions, based on the principle of “buy one, get one free”, which were prohibited in 2012, when the Reimbursement Act was introduced, reported Dziennik Gazeta Prawna.
The MoJ announced that it would continue working on the regulations to close any loopholes that enable drug export mafias to continue their activities, reported Dziennik Gazeta Prawna.
MS treatment standards should be improved
According to the report prepared by the Watch Health Care and Warsaw Enterprise Institute, standards of multiple sclerosis treatment in Poland should be improved, reported Rzeczpospolita (pA9) on Tuesday.
The report indicates that despite the recent overall improvement of MS treatment, access to the most effective therapies is still restricted. Experts say only 26% of diagnosed patients, namely 12,000 Poles, are treated, while the European average is around 50%.
The biggest challenge is to improve second-line treatment of the disease. While the treatment period for fingolimod has already been extended and a similar decision is expected to be made shortly for natalizumab, experts say the authorities should also open up natalizumab therapy to patients with anti-JCV antibodies.
The report also states that only 9% of multiple sclerosis patients in Poland receive second-line treatment, compared with the European average of 25%.
The experts say the national health fund should take into account the economic cost of the disease, not only just the additional resources required to treat a larger group of patients, as this would not only improve the quality of their lives but also bring long-term benefits to the entire system.
Counterfeiting a 'huge problem' in Poland
Dziennik Gazeta Prawna published an interview with professor Zbigniew Fijalek from the Medical University of Warsaw on Friday (pA10-A11).
Fijalek believes drug counterfeiting is a huge problem in Poland and that the authorities have been turning a blind eye to it for many years. The authorities only recently started admitting there is a problem and, according to Fijalek, all the estimates of the Chief Pharmaceutical Inspectorate regarding the issue are grossly understated.
He said that while 1% of drugs sold in traditional pharmacies could be counterfeit, most online pharmacies are illegal and more than 50% of drugs bought by Polish patients online are fakes. Fijalek said the EU introduced a register of legal online pharmacies several years ago, but in practice, pharmacists and patients are not even aware of its existence, while the authorities are not interested in launching any campaigns to raise public awareness.
He added that counterfeit drugs are dangerous because 33% of them contain no active ingredients, 20% contain the wrong doses and 20% contain other, cheaper and less effective active ingredients than advertised, which means that patients suffering from serious diseases are receiving bad treatment.
Fijalek said that while sales of counterfeit drugs in traditional pharmacies in Poland could be as high as €62 million, the total value is much higher if online pharmacies are added to this.
He added that the drug counterfeiting market is split between small-time manufacturers with production capacities of a dozen or so thousand pills per day, which account for the majority of drug counterfeiters in Poland, and large organisations with actual plants and industry-grade machinery, which export their products around the world.
Finally, there are groups stealing drugs from legitimate plants owned by pharma companies or warehouses or from vehicles in transit and, while such drugs are not fakes, they also pose a threat to patients when resold, because they usually do not satisfy the required storage conditions.
Mabion files drug with EMA
Mabion, a Polish biotech listed on the Warsaw Stock Exchange, has filed a registration application for MabionCD20 with the European Medicines Agency, reported Parkiet Gazeta Gieldy (3) on Tuesday.
MabionCD20 could potentially be used in blood cancer and rheumatoid arthritis.
Mabion is currently modernising its plant and increasing production capacity. Artur Chabowski, Mabion’s CEO, said the company is preparing to enter European markets with the support of its partner, Mylan, and planning the best way to go through with the registration process in the U.S.
Grzegorz Balcerski, an analyst from DM BZ WBK, believes Mabion’s registration process should take around 12 to 15 months.
Controversies around the sale of Bioton’s subsidiary
While Bioton intends to sell its Asian subsidiary, Scigen, something which shareholders will vote on on 11 May, it is being said that the company has not disclosed all important information on the potential transaction, reports Puls Biznesu (p1, p4 & p5) on Friday.
While the plan to sell Scigen was announced by the company’s CEO, Robert Neymann, last month, he did not reveal that Yifan International Pharmaceutical, which placed the most attractive offer, has owned NovoTek, one of Bioton’s shareholders, since November 2017.
Bioton claims it was not obliged to reveal the information about NovoTek’s and Yifan’s connections, as, according to the official accounting standards, the two companies are not classified as related parties.
Bioton’s core business is the production and sale of insulin. Most sales are made through SciGen, in which Bioton has a 95% stake and which generated revenues of 151.2 million zlotys (€35.2 million) and a net profit of 10.3 million zlotys (€2.4 million), accounting for respectively 40% and over 50% of the results of the entire group.