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Do Regulatory Changes Seriously Affect the Medical Devices Industry? Evidence From the Czech Republic.

ABSTRACT: Background: Within the EU, some of the challenges and perceived risks now facing medical device (MD) developers result from changes in the regulatory framework, emphasizing safety. Therefore, medical technology companies must adopt stricter quality assurance measures so that individual devices can be speedily tracked and retrieved in emergency situations. Objectives: We highlight the challenges and risks faced by the European medical devices industry, particularly those faced by SMEs in the Czech Republic. We address two important research questions: Q1. Do advantages from increased regulation outweigh the additional expenses? Q2. As many MD developers are SMEs, will the new regulatory regime result in some of those companies going out of business and therefore impede future innovation? Methods: The paper focuses on a single case study, with the situation and outcomes discussed in the context of the financial results of a further 50 medical device manufacturers marketing in the Czech Republic. Results: Our findings suggest that the new legislation will result in improved safety, facilitate product recalls, but the cost and administrative burden may be high. The evidence also indicates that some SMEs may be forced to diversify to "non-medical" products, with the inevitable loss of innovative MDs being made available to patients and healthcare providers.

SUBMITTER: Maresova P

PROVIDER: S-EPMC8113379 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe Czech Republic has one of the poorest tobacco control records in Europe. This paper examines transnational tobacco companies' (TTCs') efforts to influence policy there, paying particular attention to excise policies, as high taxes are one of the most effective means of reducing tobacco consumption, and tax structures are an important aspect of TTC competitiveness.Methods and findingsTTC documents dating from 1989 to 2004/5 were retrieved from the Legacy Tobacco Documents Library website, analysed using a socio-historical approach, and triangulated with key informant interviews and secondary data. The documents demonstrate significant industry influence over tobacco control policy. Philip Morris (PM) ignored, overturned, and weakened various attempts to restrict tobacco advertising, promoting voluntary approaches as an alternative to binding legislation. PM and British American Tobacco (BAT) lobbied separately on tobacco tax structures, each seeking to implement the structure that benefitted its own brand portfolio over that of its competitors, and enjoying success in turn. On excise levels, the different companies took a far more collaborative approach, seeking to keep tobacco taxes low and specifically to prevent any large tax increases. Collective lobbying, using a variety of arguments, was successful in delaying the tax increases required via European Union accession. Contrary to industry arguments, data show that cigarettes became more affordable post-accession and that TTCs have taken advantage of low excise duties by raising prices. Interview data suggest that TTCs enjoy high-level political support and continue to actively attempt to influence policy.ConclusionThere is clear evidence of past and ongoing TTC influence over tobacco advertising and excise policy. We conclude that this helps explain the country's weak tobacco control record. The findings suggest there is significant scope for tobacco tax increases in the Czech Republic and that large (rather than small, incremental) increases are most effective in reducing smoking.

Project description:PurposeThe Czech Republic has been dealing with a long-term shortage of doctors, which, according to demographic forecasts, will continue to worsen due to the retirement of stronger generations of doctors in contrast to the gradual aging of the population, which will require more health care over time. The country´s political set is trying to respond to this shortage and demographic forecasts by gradually increasing financial funding of medical faculties with the aim of increasing the number of graduates of the program in the field of general medicine.MethodsAnonymous questionnaire survey was conducted among students and graduates of general medicine at all eight Czech medical faculties. A total of 3183 respondents participated in the survey. There were 2843 medical students, which represents approximately 28% of all medical students in the Czech Republic. The distribution of respondents within the study years was approximately even and approximately corresponded to the real distribution of students between individual faculties in country, which makes survey a national sample. The statistical processing was performed in the statistical software R. Apart from the basic comparison using percentage relative frequencies and Pearson´s chi-squared test, in this study we used Odds ratios (OR) with CI 0,95 from logistic regression model for a better interpretation of some outputs.ResultsThe results show that the vast majority of Czech medical students experience excessive stress during their studies, which increases the risk of students´ somatic problems (OR = 4.89, CI 0.95 = (4.11;5.83), p < 0.001)., targeted alcohol use (OR = 2.29, CI 0.95 = (1.73;3.04), p < 0,001) and the use of anxiolytic or antidepressant medication to reduce it (OR = 2.99, CI 0.95 = (2.24;4.01), p < 0.001). Students experiencing higher levels of excessive stress are more likely to leave their studies based on their own decision (4.20 (CI 0.95 (3.39;5.19), p < 0.001) and not to enter clinical practice after graduation (OR = 2.62, CI 0.95 = (2.06;3.33), p < 0.001).ConclusionsThe survey shows the need for an open discussion at the highest level about the possibilities of reasonable reduction of unnecessary stress during medical studies. Medical students in the Czech Republic are exposed to excessive stress with all the consequences described above. All that remains is to state the existence of unnecessary components of stress, which represent an opportunity to reduce it, thereby achieving better conditions for studying, improvement in the staff situation in the Czech healthcare system and a reduction in inefficiently spent financial resources for the education of young doctors.Trial registrationNo registration.

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Do Regulatory Changes Seriously Affect the Medical Devices Industry? Evidence From the Czech Republic.

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