Ministry of Health of Ukraine has developed a new draft law On Pharmaceutical Advertising

As one of the key reform steps and strategic approaches to bringing Ukraine’s healthcare system closer to international standards, we have allowed our doctors to base their diagnosis and treatment recommendations on current international protocols.

Therefore, each doctor will now be sure that the treatment s/he recommends to a patient is the most effective and best solution known to humankind to date, while each patient will have a great tool for healthcare quality control.

World science is not static, it is marked by a steady progress and Ukrainians should keep abreast with the latest advancements and developments. Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. So, please use them.

UNIVERSAL

• Up To Date http://www.uptodate.com
• BMJ Clinical Evidence http://clinicalevidence.bmj.com
• Medscape from WebMD http://www.medscape.com
• National Guideline Clearinghouse https://www.guideline.gov/
• Centers for Disease Control and Prevention (CDC) https://www.cdc.gov/
• The Cochrane Collaboration The Cochrane Library http://www.cochrane.org/
• Clinical Knowledge Summaries (CKS) http://prodigy.clarity.co.uk/

NATIONAL

• The Finnish Medical Society Duodecim https://www.duodecim.fi/
• The Association of the Scientific Medical Societies in Germany http://www.awmf.org
• The French National Authority for Health http://www.has-sante.fr/
• National Institute for Health and Clinical Excellence (NICE) https://www.nice.org.uk/
• Canadian Medical Association InfoBase (CMA InfoBase: Clinical Practice Guidelines (CPGs) http://www.cma.ca/
• The National Health and Medical Research Council (NHMRC https://www.nhmrc.gov.au
• Royal College of Physicians https://www.rcplondon.ac.uk/
• AMA (American Medical Association) https://www.ama-assn.org/
• American Academy of Family Physicians http://www.aafp.org/home.html
• American Academy of Pediatrics Policy (AAP Policy) Clinical Practice Guidelines https://www.aap.org
• European Pediatric Association, the Union of National European Pediatric Societies and Associations (EPA/UNEPSA) http://www.epa-unepsa.org/

CARDIOVASCULAR DISEASES

• American College of Cardiology http://www.acc.org/
• American Heart Association http://news.heart.org/
• European Society of Cardiology http://www.escardio.org/

TRAUMA

• Brain Trauma Foundation (BTF) https://www.braintrauma.org/http://www.trauma.org/
• Eastern Association for the Surgery of Trauma https://www.east.org/
• Western Trauma Association https://westerntrauma.org/

ONCOLOGICAL DISEASES

• National Comprehensive Cancer Network https://www.nccn.org/
• The European Society for Medical Oncology http://www.esmo.org/

EMERGENCY MEDICAL SERVICES 

• American College of Emergency Physicians https://www.acep.org/
• The National Association of Emergency Medical Technicians (NAEMT) http://www.naemt.org/
• The National Association of State EMS Officials https://nasemso.org/
• The European Society for Emergency Medicine http://eusem.org

The Ministry of Health of Ukraine has initiated the improvement of national policies regulating advertising of medicines and healthcare products. The Ministry’s primary objectives are to harmonize the current Ukrainian legislation with EU norms and to establish rigorous control over the pharmaceutical advertisement content to prevent all sorts of information manipulation.

Currently, pharmaceutical advertising accounts for the largest segment of the Ukrainian TV advertising market. According to the National Council of Ukraine on Television and Radio Broadcasting, advertisements of medicines and medical products constitute about 30-50% of the overall TV advertising in Ukraine, and on some TV channels the share of pharmaceutical advertising even reaches up to 70%.

The biggest problem in pharmaceutical advertising is the deliberate manipulation of information about the advertised product and its properties. The most striking indicator of the effect of pharmaceutical advertising on patients is that the share of symptomatic drugs and medicines without proven efficacy comprised more than 50% of the total medicines consumption in 2017. Meanwhile, every second patient in Ukraine refused or could not afford necessary treatment.

It is also worth noting that due to unregulated pharmaceutical advertising practices many Ukrainians choose to self-medicate and to diagnose themselves using Google. Results of the latest sociological surveys show that about 69% of patients in Ukraine practice self-medication instead of seeking qualified medical advice. This results in an increased incidence of complications, especially in chronically ill patients, which affects, in turn, the overall high disability rates and reduces life expectancy.

"The practice of taking medicines without doctor's advice is actually one of the biggest challenges faced by the Ministry of Health of Ukraine as a central policy-shaping authority in this field. It is very important that patients receive true and complete information about medicines; therefore, we must ensure that no information manipulation is possible in pharmaceutical advertising. Currently, we have limited options. In fact, under the current Ukrainian legislation, the Ministry of Health is not involved in the pharmaceutical advertising monitoring and control, " commented Roman Ilyk, Deputy Minister of Health of Ukraine.

The new draft law On Pharmaceutical Advertising should harmonize the current Ukrainian legislation with EU rules, and, in particular, address the issue of pharmaceutical advertising to healthcare workers. The draft law provides for the development of a precise list of specialized medical editions which will publish detailed information on medicines, advertising of which is prohibited or restricted by law, as well as for the development and approval by the Government of a special order On Advertising of medicines and medical products to healthcare and pharmaceutical workers.

"In Ukraine, pharmaceutical advertising to doctors is not regulated at all. It is a taboo. Meanwhile, many European countries have already established clear rules and regulations on the pharmaceutical advertising distribution to medical representatives, in professional editions and medical journals, and at specialized medical conferences. This is the way to present the latest treatment innovations," noted Maryna Slobodnichenko, legal expert at the Ministry of Health of Ukraine.

The proposed changes also envisage new advertising content restrictions developed in accordance with the relevant European guidelines. In particular, new rules will prohibit the use of any links or references to disease diagnosis or treatment planning conducted over the phone or online, the advertising of medicines by celebrities or actors playing the role of medical professionals, and the use of any information indicating that a particular medicine is intended exclusively for the treatment of children. Moreover, the advertisement content must comply with the SmPC (summary of product characteristics) of the advertised drug.

A separate item in this legislative initiative suggests prohibition of advertising all sorts of traditional folk medicines and healing practices.

The draft law stipulates that the Ministry will now carry out the monitoring and control functions, and that TV and radio broadcasting companies will face tough penalties for failing to comply with the rules or violating legislation on pharmaceutical advertising. The National Council of Ukraine on Television and Radio Broadcasting will be authorized to apply sanctions against such companies by charging 5% of the license fee for one such violation.