TeamDrive
RUS

Russian authorities proposed to introduce liability for false drug prices

13 September 2017

GMP News

The Russian Ministry of Health proposed to introduce administrative liability for legal entities in case of false information provided during the state registration/re-registration of maximum selling prices for the medicines included in list of vital and essential drugs (VED).

Currently, the law does not stipulate any liability of legal entities (holders or owners of the registration certificate of medicinal product for human use, or party authorized by such holders or owners) for providing false information at the state registration (re-registration) of the manufacturer’s maximum selling prices for medicinal products included in the list of vital and essential drugs.

The draft federal law provides for amending the Russian Code of Administrative Offenses for submission of false information by the holder or owner of the registration certificate of medicinal product for human use (party authorized by such holders or owners) during the state registration (re-registration) of the manufacturer’s maximum selling prices for medicinal products included in the list of VED, changes to the register’s entry on the state registration of the manufacturer’s maximum selling price for medicinal product, which affected the results of economic analysis of the manufacturer’s maximum selling price of medicinal product for human use and led to unreasonable increase of the manufacturer’s maximum selling price for medicinal product.

According to the draft law, these offenses would entail the imposition of administrative fine on legal entities in the twofold the excess of the proceeds received from the sale of medicinal products as a result of unreasonable increase of the manufacturer’s maximum selling prices for medicinal products during the entire period in which the offense was committed, but no more than one year.

Source


Previous publication Next publication

Media Center

  • 16 February 2018

    Pfizer taps BC for real-world cardiovascular research drive

    Pfizer has teamed up with BC Platforms to generate real-world evidence on cardiovascular diseases. The collaboration will leverage BC’s technology and Finnish health records to better understand atrial fibrillation patients.

  • 16 February 2018

    Pharma and AI: Help doctors with AI assistants but don’t try to replace them

    Dr. Robot gets a thumbs down from patients, according to new research from Syneos Health. Despite tech and investor enthusiasm, along with media headlines highlighting artificial intelligence in healthcare, patients are adamant that artificial intelligence should not replace doctors.

  • 15 February 2018

    Pharma Looks to Change the Healthcare Cost Conversation

    Amidst the continuing clamor for government action to curb prescription drug prices, a more collaborative effort aims to broaden the debate to consider the full range of healthcare services and rates that affect spending in this area. The National Pharmaceutical Council (NPC), a pharma-funded research organization, is partnering with the independent journal Health Affairs to examine the root causes of rising healthcare outlays in the United States. This two-year program will support academic and professional research projects and commentaries to be published and disseminated online by the journal.

  • 15 February 2018

    FDA Releases Guidance on Systemic Antibacterial Drugs

    FDA published guidance on the development, analysis, and presentation of microbiology data during the development of antibacterial drugs. The agency discusses the overall microbiology development program it says is needed to support clinical development and approval of antibacterial drugs administered systemically. The guidance also addresses microbiology data collected after drug approval.

Read more