Reforms to the healthcare regulatory system have been proposed, involving changes to the investigative powers of the National Institute for Quality and Organizational Development in Healthcare and Medicines ( “GYEMSZI”).

The draft bill has not yet been adopted: it was submitted on 20 May and is waiting for amending resolutions.

The key changes proposed are summarised below.

Extending GYEMSZI’s powers

GYEMSZI would be given extensive investigate powers, similar to those of the tax office and competition authority. These would allow it to:

  • request any person or entity to make a statement
  • require any person or entity to surrender any document kept by it or data held by it
  • make a forensic copy of any data medium
  • get to know and process the personal data of any clients or persons connected to clients (including personal data unrelated to the subject matter of proceedings that can still be linked to any means of evidence)
  • search any premises (including private apartments) and ask anyone staying there to make statements. (Searches may only be conducted with the prior approval of a public prosecutor, with the persons concerned preferably present throughout.)

Increase in fines

The range of fines for breach of the “obligation to supply medicinal products” (under Act XCV of 2005, s. 20(5)) would rise to HUF 100,000 to 500 million (c. € 340-1,687,000). Central implant register

Regulatory changes would allow data in registers kept by health care providers to be forwarded to the Central Implant Register in order to create a uniform registration system for implantable medical devices .

Human genetics

Changes (to Act XXI of 2008) would:

  • separate the concept of bio-banks from other cell and tissue banks,
  • allow different types of human genetic examination according to their goals (clinical studies conducted on people exhibiting symptoms of illnesses and symptom-free persons, and clinical studies conducted for research purposes)
  • specify the circumstances under which health care providers could carry out human genetic studies.

Central procurement process for hospitals

The first central public procurement procedure for hospitals was completed in May 2013, and is expected to deliver cost savings of around 10%.

The procurement procedure was used to purchase 16 active ingredients (with a value of c. HUF 1.4 billion) for nationalised hospitals and centres for medical treatment.

The original proposal was for 62 active ingredients to be purchased. However, an invitation to tender will soon be issued to purchase significantly large quantities of the same 62 active ingredients (worth c. HUF 4-5 billion) in a second procurement proceedings.