WARSAW, 16 Aug (APM) - According to the ruling of the Court of Justice of the European Union in the case of Delfarma, whose request to import a drug from the UK was rejected by the Polish authorities, parallel imports of drugs should be free, as is reflected in the principle of the free movement of goods within the EU, reported Dziennik Gazeta Prawna (pB11) on Wednesday.
Delfarma, a parallel importer applied to the registration office for permission to import a drug from the UK. This permission was refused, which was justified by the Pharmaceutical Law, which prevents parallel imports of a counterpart of an originator drug that has marketing authorisation in Poland, even if they have identical properties.
The Court of Justice held that imports of goods can be restricted to protect human health and lives. Meanwhile, as both drugs had identical properties, the refusal to allow parallel imports was not justified by the protection of human health or lives.
This judgment means that if a reference drug is authorised in one country of the EU, a generic does not need to be authorised, but may be imported under the procedure of parallel imports. Therefore, the registration office will no longer be able to refuse permission for parallel imports based purely on the failure to satisfy a formal condition.
Tougher controls to combat falsified medications
According to the latest anti-fraud amendment to the Pharmaceutical Law that came into effect on Tuesday, the Chief Pharmaceutical Inspector will manage the national drug database and check whether the pharmas are introducing individual security codes on their products, while the Voivodship Pharmaceutical Inspectors will check whether the pharmacies are properly examining drug authenticity, reported Rzeczpospolita (A15) on Wednesday.
More reimbursable therapies needed to help fight drug-resistant epilepsy
According to experts, appropriate diagnosis and access to individual reimbursed therapies should help patients suffering from epilepsy to return to their normal lives, reported Rzeczpospolita (pA10) on Wednesday.
Around 1% of Poles suffer from epilepsy. 1/3 of whom suffer from drug-resistant epilepsy. 17 active ingredients are currently reimbursable for treating epilepsy, but doctors and experts want new drugs to be added, as despite different therapies being of the same level of effectiveness, they are differently tolerated by individual patients.
More Polish cities will promote vaccinated children in nursery school registrations
The ruling of the Voivodship Administrative Court in Gliwice allowing the city of Czestochowa to promote vaccinated children during registration to childcare facilities, increasingly more cities want to apply similar regulations to help fight the growth of the antivax movement, reported Rzeczpospolita (pA15) on Wednesday.
According to the Chief Sanitary Inspectorate (GIS), Poland saw over 42,000 cases of parents refusing to vaccinate their children in the first quarter of 2019. GIS is comparing this number with the reports from the same period of 2010, when 3,437 such cases were recorded.
The Polish drug crisis increased the distance between individual and chain pharmacies
The Supreme Pharmaceutical Council will investigate whether large pharmacy chains were favoured over individual pharmacies in the supply of drugs listed as limited or unavailable on the market during the Polish drug crisis in July and August, reported Dziennik Gazeta Prawna (pB4) on Tuesday.
While the situation is understandable from the free market or business relations point of view, pharmacists find it unacceptable given the health hazard to patients who are unable to buy the medicines they need. The Pharmaceutical Council considers the practices of supplying pharmacies according to their size to be in conflict with the pharmaceutical and competition laws.
Pharma circles want a consensus conference on the pharmacist bill
The bill on the profession of pharmacist that entered public consultations last month has stirred controversies among both pharmaceutical and medical circles, reported Rzeczpospolita (pA12) on Monday, Rzeczpospolita (pA15) on Tuesday and Dziennik Gazeta Prawna (pB5) and Puls Biznesu (p12) on Wednesday.
The bill’s intention is to increase the importance of pharmacists and introduce pharmaceutical care. An increase in the responsibilities of pharmacists working in hospitals is also expected. Other than normally issuing orders and organising tenders, collecting supplies of medications and distributing them among the wards, hospital pharmacists will need to complete patient pharmaceutical records and assess whether the prescribed therapy is appropriate for the given patient. However, the Act should legally increase the number of pharmacists per hospital so they can fulfil their new duties, as many hospitals only have one pharmacist, reported Rzeczpospolita on Monday.
The pharmacy associations claim the bill will reduce competition among pharmacists, as it will give the pharmaceutical council greater powers, effectively giving it the rights of a pharmacy market regulator. However, the Supreme Pharmaceutical Council claims this would be more desirable than the current situation in which non-pharmacist employers of pharmacists can exert pressure on their employees to make decisions that could be inappropriate for patients reported Rzeczpospolita on Tuesday.
Doctors are also anxious about the proposed changes in some cases, such as the creation of drug programmes and pharmaceutical care as a whole, as, under the current law, it will be the doctors who will be held responsible for all prescriptions, treatments and recommendations of pharmacists, added Dziennik Gazeta Prawna on Wednesday.
The Union of Entrepreneurs and Employers fears that the Act will disrupt the rules of the free pharmaceutical market by increasing the rights of pharmaceutical councils to decide on who is to be a pharmacy manager, to withdraw a pharmacist’s licence and withdraw a pharmacy licence. Additionally, increasing the rights and responsibilities of pharmacists will adversely affect the role of pharmacy technicians, as they are expected to be limited to purely organizational and technical roles, added Puls Biznesu on Wednesday.
OncoArendi seeks investors in China
OncoArendi has signed one non-disclosure agreement and its two different contracts are near conclusion with Chinese biotech and investment companies, which are interested in cooperation on the OATD-01 and OATD-02 platforms, reported Parkiet Gazeta Giełdy (pA15) on Tuesday.