An important part of the tasks of the Polish Agency for Health Technology Assessment and Tarification is the evaluation of medicines. The recommendations/positions and opinions issued mostly concern medicinal products. Pharmaceutical technologies are evaluated at the Agency at the request of the Polish Minister of Health.
In the Polish health system, citizens’ access to medical technologies (pharmaceuticals, medical devices, medical procedures and organizational systems) is regulated by the insurer – the National Health Fund – based on a technology assessment. Health Technology Assessment is of increasing importance in medical technology reimbursement decision-making, providing a rational basis for these decisions.
The Guidelines for the Evaluation of Medicinal Products (Version 3.0) indicate how the evaluation of pharmaceuticals should take place:
– what each analysis should include, and
– how they should be prepared.
EVALUATION ELEMENTS
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Artificial intelligence (AI) used in medical devices
Artificial intelligence (AI) technologies are being used more and more boldly in areas that until now were reserved exclusively for humans. They are mainly used in decision-making, image analysis, speech, or natural languages analysis. These systems involve creating models of intelligent behaviour that can be used in computer programs and solve problems that cannot be solved using standard classical algorithms. This requires large amounts of data through which AI applications learn patterns and features that predict the output. This makes them different from classical algorithms, which have predefined rules and which AI creates on its own based on data provided to it. In medical devices AI causes operational speeding up of mechanisms and analysis of particular cases.
Artificial intelligence in medical diagnosis and prognosis
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In the US, in the context of the case of donor 1558 a legislative initiative has been launched to protect the parents of children conceived using genetic material taken from a donor.
In the case widely discussed in the press, 27-year-old Steven Gunner died of a drug overdose. His biological father was sperm donor number 1558 who according to the biobank’s description, was a brown-eyed student who played guitar and hockey. After the tragedy, Steven’s parents learned that the sperm donor suffered from schizophrenia and died the same way as Steven – from a drug overdose. As a result of their actions, Republican Senator Gallivan introduced a draft legislation to waive the donor’s confidentiality for a period of five years back so their medical records could be checked.
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Poland has in place a system of guidelines for the evaluation of medical devices. The purpose of the guidelines is to indicate principles and acceptable methods for conducting the medical technology assessment process for medical devices, ensuring high quality analysis and reliability of the results.
The guidelines refer to the medical devices applied for in order to be covered by the guaranteed benefit status as defined in art. 15 par. 2 item 14 of the Polish Act on health care services financed from public funds (Journal of Laws 2020, item 1398, as amended), and which are processed in accordance with art. 25 of the Polish Act of 12 May 2011 on reimbursement of medicines, foodstuffs for particular nutritional uses and medical devices (Journal of Laws 2020, item 357, as amended) and which meet all of the following criteria:
(a) are mass produced;
(b) are intended for use by an individual patient;
(c) are materially superior to products currently receiving public funding, the burden being on the applicant to demonstrate the claimed superiority;
(d) are therapeutic medical devices or are used for prophylaxis (they are not diagnostic medical devices).
When the medical device contains a drug product, the documentation should address the requirements described in the Health Technology Assessment Guidelines (Version 3.0) developed for drug technologies.
DEFINITION OF MEDICAL DEVICES AND MEDICAL TECHNOLOGY ASSESSMENT UNDER POLISH LAW
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KIELTYKA GLADKOWSKI KG LEGAL is heavily involved in complex assistance to clients operating in clinical trials sector and it diligently observes the market in this respect within new technologies used in clinical trials. In 2020 there have been noted considerable challenges for the science and technology, including technologies in clinical trials. The pressure that has been placed on the healthcare systems turned out to be unprecedented. The rapid spread of coronavirus has lead to the global debate on the reassessment of the approach to clinical trial conduct. Previously, it was believed that the driving force of medicine development is technology.
Remote clinical trials: a new standard
In March 2020 biopharmaceutical companies managed to conduct more than 9,000 clinical trials in the U.S. However, the pandemic outburst has brought the future biopharma development into a question. Nevertheless, some researchers decided to take the advantage of the wide range of available information and communication technology devices. Combining novel tactics like mailing medications and relying on digital technologies such as transmitting photos of home-based blood pressure readings via text message has resulted in remote clinical trials. At this point, it is fundamental to stress the surprising advantages of clinical trials conducted remotely, which are:
- personalizing and strengthening patient engagement,
- accelerating recruitment (recruiting more people and more quickly than with a local study),
- improving patient diversity and data quality (reaching greater geographic area and patients of different ethnic background, providing more comprehensive patient monitoring),
- accelerating time to market.
Wearable technologies in remote clinical trials
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