Law is my biggest hobby and I can't imagine doing anything else. What I enjoy most about it is that every day is different and brings new challenges. I specialise mainly in pharmaceutical and health law, which I interweave with the agenda of contract law, intellectual property law, unfair competition, advertising, and public regulation. In my free time I like to get to know other cultures through the study of foreign languages. I always learn at least the basic phrases before I go abroad on my vacation. If I had to move somewhere, it would be Switzerland.
frantisek.neuwirth@havelpartners.czArticles by the author
Advertising Medicinal Products and Medical Devices: Will the Amendment Bring Clarity or Confusion?
The Chamber of Deputies is currently discussing a long-prepared amendment to the Act on Regulation of Advertising (Chamber of Deputies Document 918, available here). The proposed amendment introduces several significant changes to the rules for advertising of medicinal products and medical devices.
Advertising of medicinal products: What does the new version of SÚKL’s guidelines bring?
After more than a decade, the State Institute for Drug Control (SÚKL) has released an updated version of its guidelines UST-27 (full text available here: UST-27 version 4 - SÚKL). This new version, effective from 1 January 2025, clarifies the rules for advertising medicinal products, particularly sp
Is a patient program really a medicine advertisement? And why couldn’t a pharmaceutical company organise it?
A draft amendment to the Advertising Regulation Act has recently been published and is now due to be discussed by the Government and Parliament. It proposes a number of changes, including in the area of advertising of medicinal products. The attentive reader will be in for many surprises when readin
Will it be possible to promote hospital medical devices to the general public?
Many stakeholders in the medical device market are unaware that the current Advertising Regulation Act prohibits the promotion of medical devices intended solely for use by healthcare professionals (commonly referred to as “hospital” medical devices) to the general public.
What is the future of medical devices reimbursement regulation?
In July, the General Health Insurance Company of the Czech Republic (VZP), the major Czech payor, published updated guidelines for enlisting hospital medical devices in VZP’s product list. In this respect, Jiří Štěrba, Director of the Medical Devices Department of VZP, told Zdravotnický deník that V
Can we expect new legislation on the reimbursement of medical devices? Hospital medical devices still overlooked
In May, the inter-departmental comment procedure concluded for a new act that would regulate reimbursement of prescription medical devices, such as incontinence pads, prostheses, hearing aids, and glucometers, as well as dental products covered under public health insurance. The proposals include tr
Online sales of prescription drugs: Will it be allowed?
We can buy almost everything online. However, we still have to pick up our prescription drugs in person at the pharmacy. Does such a restriction make sense in the digital age?
Amendment to the Act on Medicinal Products; new obligations to ensure availability of medicinal products
An amendment to the Act on Medicinal Products entered into effect as of 1 January 2024, imposing numerous new obligations on marketing authorisation holders, distributors and pharmacies, and expanding the existing powers of administrative authorities. The changes are primarily aimed at ensuring the
Czech government approved new obligations to ensure availability of medicines – is the market ready?
Marketing authorisation holders, distributors and pharmacies may be facing new obligations to ensure the availability of medicinal products on the Czech market. In fact, on 14 June 2023, the Government approved an amendment to the Medicines Act. The proposal will now be debated in the Chamber of Dep