60% of currently employed in the pharmaceutical industry Qualified Persons could lose their jobs due to the amendment of the Pharmaceutical Law dated 7th of June, 2018.
According to art. 8 of mentioned above amendment, a Qualified Persons, who are not pharmacists, must within six years from the date of entry into force of the amendment complete the education in the range of physics, general and inorganic chemistry, organic chemistry, analytical chemistry, pharmaceutical chemistry including analysis of medicinal products, general and medical biochemistry, physiology, microbiology, pharmacology, pharmaceutical technology, toxicology and pharmacognosy in order to still be able to be employed on this position.
In practice, this means that many experienced with appropriate practical skills Qualified Persons will cease to perform their functions if they do not complete their education from the formal side.
The new regulations[1] impose an obligation to train Qualified Persons, but do not specify where and how it can be done.
Due to the lack of any actions from the regulatory side and bearing in mind the fate of Qualified Persons, PASMI Polish Association of the Self-Medication Industry issued a letter to crucial authorities, including the Minister of Health and to the Chairman of the Convent of Deans of the Faculties of Pharmacy at Medical Universities with a request for immediate action to enable the training of Qualified Persons.
„Considering the very wide range of training and at the same time, the lack of defining the rules and place where this knowledge can be supplemented, we asked for the establishment of educational structures as soon as possible. The transitional period, which is introduced in the act, should be used at the most by Qualified Persons, which increases their chances for the most effective completion of knowledge and retention of job on the current position.” – says Ewa Jankowska, President of PASMI’s Management Board.
The amendment of the Pharmaceutical Law according to Qualified Persons does not guarantee people currently employed on this position the professional continuity, therefore this problem was urgently addressed.
In response to the PASMI appeal, the Convent of Deans of the Faculties of Pharmacy at Medical Universities in cooperation with the current National Consultant in the field of industrial pharmacy took steps to enable the Medical Universities to train Qualified Persons.
As a result of the cooperation, it was established that Qualified Persons who do not have a pharmaceutical education will be able to take up training form October this year at the Pharmaceutical Faculties of the following Medical Universities:
- Jagiellonian University
- Medical University of Lublin;
- Medical University of Silesia;
- Medical University of Wroclaw.
Moreover, in 2020 the studies will start at the Pharmaceutical Faculties of the following Medical Universities:
- Medical University of Gdańsk;
- Medical University of Lodz;
„Lack of key people in the process of releasing a medicinal product to the market would pose a threat to availability of medicinal products in Poland. This would affect the polish pharmaceutical industry the most. We are delighted with the results achieved and we highly value the involvement of Medical Universities in working out the opportunities of training key people at the above-mentioned scientific units” – concludes President of PASMI’s Management Board.
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PASMI Polish Association of Self Medication Industry promotes the responsible self-medication among the society through a conscious and safe use of products classified as drugs sold without Prescription. It pursues to establish relevant legal and systematic solutions for the development of the responsible use of OTC drugs as one of the elements of the healthcare system.
PASMI cooperates actively with European organisations whose goals and operations are in line with the statutory activity of PASMI. PASMI is a member of AESGP – Association of the European Self-Medication Industry. Currently, the Association has 20 members: Aboca, A&D Pharma, Adamed, Bayer, Biocodex, GSK, IPSEN Poland, Johnson&Johnson, Klosterfrau, Omega Pharma Poland, Queisser Pharma, Pfizer, Polpharma, Reckitt Benckiser, Sanofi, Takeda, Teva, USP Zdrowie, Verco and Polish Herbal Committee as a supporting member
[1]Article 48 of the uniform text of the Act of 6 September 2001 on Pharmaceutical Law, Journal U. of 2019, item 499.
