WARSAW, 11 Jan (APM) - New regulations preventing the sale of counterfeit drugs are soon to be passed in Poland, Dziennik Gazeta Prawna (pB6) reported on Tuesday.
The changes will almost certainly increase the cost of doing business in the sector, but the officials claim this will not affect drug prices for patients.
Experts believe 1% of all drugs sold in pharmacies could be falsified.
The new regulations should be implemented in Poland by 9 February after authorities have integrated Europe’s Directive 2001/83/EC supplementing Regulation 2016/161 to further prevent sales of counterfeit drugs, Dziennik Gazeta Prawna noted.
According to the regulations, all reimbursable and some non-reimbursable drugs will need to have special labelling confirming their legitimate origin.
Such drugs will only be sold by pharmacists if they are verified by the IT system as being legal. Otherwise pharmacists will be required to inform the Chief Pharmaceutical Inspectorate who will need to monitor the data entered into the IT system.
Pharma wholesalers will also have to ensure that the IT system enables the swift withdrawal of suspicious drugs from distribution before they reach anyone who cannot be audited by the Chief Pharmaceutical Inspectorate.
Poland still failing to block drugs being exported illegally
Polish authorities are continually failing to block illegal exports of drugs - an illicit industry which could be worth as much as 3.5 billion zlotys (€812.1 million) per year, Dziennik Gazeta Prawna (pA4) reported on Wednesday.
The findings came from a report prepared by the Supreme Audit Office (NIK). It said that 57% of all Poland’s drug exports are illegal and that, over the last two years, pharmacists had notified the Chief Pharmaceutical Inspectorate (GIF) 16.5 million times that they could not order drugs from wholesalers.
The list of drugs to which access is currently restricted in pharmacies contains 311 products, mainly cancer drugs, anticoagulants and vaccines.
While the officials have been trying to curb illegal drug exports by introducing more restrictive regulations, the biggest problem is that GIF does not have the manpower and tools to effectively manage the situation, while cooperation between various authorities and the courts is inadequate.
Additionally, the Ministry of Health has failed to develop an integrated IT system to help monitor drug sales.
Polish authorities claim they are still working on solutions, though they cannot ban drug exports in general as this would be in conflict with EU regulations. Still, they have prohibited entities from simultaneously operating a pharma wholesale business and a pharmacy, which should create an obstruction for the reverse supply chain used in illegal exports.
Pharma firms are Poland’s top advertisers
According to the Institute of Media Monitoring, pharma companies spent over 4.2 billion zlotys (€974.5 million) in Poland on television, press and radio advertising in 2018, which makes them the country’s top advertisers, Dziennik Gazeta Prawna (pA7) reported on Wednesday.
The biggest spend was on advertising for colds and flu drugs (19%) and analgesics (15%). Spending was also aimed at the marketing of vitamins, minerals, dietary supplements and indigestion products.
The most actively promoted brands were GlaxoSmithKline’s Voltaren (diclofenac), Polpharma Biuro Handlowe’s Biotebal (biotinum), US Pharmacia Sp’s Ibuprom (ibuprofen), Natur Produkt Pharma’s Molekin vitamins and Neoceuticals’ NeoMag (magnesium).
Anti-vaccinations lobbyists call for Polish state-funded study
Anti-vaccination lobbyists have urged the Polish government to organise a study on a representative group of children whose parents have refused to allow vaccination, in a bid to finally determine the effects of vaccines on the population, reported Dziennik Gazeta Prawna (pB11) on Monday.
The Ministry of Health has received six such requests from individuals so far.
The authors say that data from around 30,000 cases where parents have refused to have their children vaccinated could be used as the control group and that it would be the easiest way of conducting the study.
It would compare all health-related events in both groups of patients, therefore ultimately enabling the establishment of whether vaccinations are beneficial or harmful. It could take years to analyse the data, however, the newspaper notes.
The authors believe the study would cost a dozen or so million zlotys per year and could be conducted either by the National Institute of Hygiene or the soon-to-be-established Medical Research Agency. Polish authorities are still refusing to comment on the idea.
Pharmacists should not be forced to sell more drugs
The vice-president of the Supreme Pharmaceutical Council, Michal Byliniak, claims it is high time to stop pressuring Polish pharmacists into maximising sales, Rzeczpospolita (pA14) reported on Tuesday.
Byliniak said the current regulations do not draw a clear line between business and sales activities and the ethical standards which should apply as a pharmacist.
He added that the regulations should clearly specify that the interest of patients and that pharmacists should not be pressured by business owners to operate as ‘ordinary salesmen’.
Bioton’s subsidiary loses LG Chem court battle
Bioton’s Swiss subsidiary Biopartners has lost its $6 million court case accusing Korea’s LG Chem of failing to hold up its end of a growth-hormone development pact, Parkiet Gazeta Gieldy (p4) reported on Saturday.
The case - which Puls Biznesu (p7) also covered on Monday - centred around a contract from 2001 for the development and commercialisation of an innovative long-acting growth hormone.
Bioton claimed LG Chem failed to provide the product to Biopartners, even though the hormone received its registration certificate enabling its sale in the EU after twelve years.
Biopartners is now required to cover all the court and legal fees of over $3.1 million, both newspapers reported.
Eli Lilly & Co. to acquire Loxo Oncology
Eli Lilly intends to acquire cancer drug company Loxo Oncology, for $8 billion, Rzeczpospolita (A23) reported on Tuesday (APMHE 61318
The transaction is to be finalised by the end of the first quarter 2019.