Arterium Corporation: transparent and competitive government procurement system for drugs and medical supplies is good for everyone

     The urgent introduction of special qualification requirements (WHO prequalification *) and involvement of international organizations in the government procurement of drugs and medical supplies is currently a subject of intense public debates. Being a leader in the Ukrainian pharmaceutical market, Arterium Corporation deems it necessary to share its opinion on this matter.
The company welcomes the adjustments in government procurement management required to introduce transparent and fair terms. We are convinced that it will be beneficial for patients, the pharmaceutical market and the state budget alike. Domestic producers are interested in establishing equal and clear government procurement terms. Almost 3 of 4 drug units sold in Ukraine are domestically produced. However, according to Apteka, a Ukrainian weekly pharmaceutical publication, Ukrainian producers constituted a mere 13% in terms of money during the 2014 centralised government procurement campaign.
     Several pharmaceutical quality standards are currently used in the world. The best known and the most trustworthy are the EU GMP and the US FDA. The Ukrainian pharmaceutical industry has long chosen to follow the European standards and fully complies with them, with hundreds of millions invested over the past decade to make it happen. The WHO quality standards are an alternative quality system, which the WHO uses in global procurement programs (primarily in countries without domestic pharmaceutical production). Many drugs across the globe are yet to be prequalified as per WHO standards. According to the WHO website, only 509 medicinal products with a limited set of prescriptions have passed prequalification thus far. Although not in the list, numerous drugs are still sold in the EU markets, being ultimately GXP-compliant (GMP for production, GLP for quality control, GCP for clinical trials, GDP for drug distribution).
     WHO prequalification becoming mandatory for participation in tenders will make the market uncompetitive over the next few years. According to our estimates, a prequalification takes at least 2 years. Should the national pharmaceutical industry (60,000 jobs, 3% of Ukraine's GDP) be excluded from government procurement, the companies may lose competitiveness and the patient's interests may be affected, as well as the country in general.
     We hope the regulator and specialized international organizations will defer to this opinion, making the WHO prequalification optional and removing other discriminatory conditions from the tender documentation. Enforcement of the WHO standards could be justified for imported products that are yet to be registered in the country. Since critical imports are subject to the special conditions of product registration for the procurement in question on the territory of Ukraine over 14 days, WHO prequalification would be a satisfactory quality guarantee for import medicinal products to be registered over such a short time-frame.
* World Health Organization