POLAND Trends and Developments Contributed by: Barbara Kiełtyka, Jakub Gładkowski and Małgorzata Kiełtyka, Kieltyka Gladkowski KG Legal
use procedure – which unfortunately did not come to fruition. Investments in the Life Sciences Sector in Poland and Financing Models Changes have occurred in the way biotechnol- ogy companies and investment funds operate. In recent years, many biotechnology compa- nies have used technologies based on genetic information to create so-called biomolecular platforms. These platforms intervene at differ- ent points in the biomolecular information chain to modify the processes that cause diseases. The software-based nature of this approach to drug development allows for the design of many new therapies on a single platform that contains instructions for modifying the molecular hardware associated with the diseases. A bio- molecular platform, in contrast to the traditional approach of focusing on a single technology, allows for the development of multiple thera- pies simultaneously. Companies with a biomo- lecular platform start working on a therapeutic solution by building a platform and designing experiments to demonstrate its usefulness as a source of therapeutics (eg, vaccines). They then identify diseases, therapeutic areas or groups of biologically related diseases that can be treated with these therapeutic tools, and finally priori- tise drug discovery and development for select- ed diseases. Digital/IT solutions are an integral part of the biomolecular platform-based model at every stage of the project, from drug discov- ery and the preclinical phase to clinical trials and manufacturing. Another important trend is the application of the portfolio model to the financing and man- agement of biotechnology R&D. The portfolio model is an innovative business model in which a portfolio manager controls a set of companies or projects spanning multiple technologies and
therapeutic areas. Rather than focusing on a sin- gle technology, the portfolio manager draws on experience in fundraising, investing, venture cre- ation, R&D, manufacturing, commercialisation, management systems and credibility building – as well as relationships with key stakeholders – to assemble a portfolio of investments, each of which is assigned to a unique drug programme. In the portfolio model, investors allocate capi- tal to a central management team that offers a competitive advantage through its expertise in managing a variety of different companies and organisations. The new model allows the portfo- lio manager to raise capital from a broader group of investors. There is evidence that the portfolio model is an effective mechanism for managing R&D in the life sciences sector in Poland. Access to Medicinal Products for Patients: Architecture of the Pharmaceutical Law in 2025 Poland, as one of the 27 members of the EU, has a very large number of regulations pertaining to the quality, efficacy and safety of drugs and drug marketing authorisation. In the following, trends in this area set to continue in 2025 are detailed. Greater information requirements The Pharmaceutical Law focuses on regulating the release of medicinal products prescribed by a doctor to a patient. Currently, the regulations take into account the progress of a prescription through the IT system and documentation of the patient’s need for a drug. A recent example is a regulation that specifies that more information is required for the release of a drug to a patient, based on communication between the doctor and a pharmacist. This is associated with the new principle whereby it is not necessary to fulfil the entire prescription in one pharmacy (amend- ment to the Act of 27 August 2004 on healthcare services financed from public funds; Journal of
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