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National policies

• Almost 2% of the GDP in the European Union is spent on pharmaceuticals.[1]
• The ratio of public to private funding of pharmaceutical expenditure varies widely in the WHO European Region, from 90% being publicly funded in the Netherlands and United Kingdom to less than 50% in Latvia, Lithuania and Poland [2], and even less than 50% in all newly independent states.
• WHO recommends that all countries formulate and implement a comprehensive national medicines policy (NMP) that includes legislation, medicines selection, regulation and quality assurance, procurement and distribution, pricing and reimbursement, education and training, information for the public, and research and development.

Access

• Statistics estimate that one-third of the world population does not have regular access to the essential medicines they need. [3]
• In 2007, each citizen in the European Union spent an average of 430 euros on medicines. [4]
• From international price surveys it was found that originator brands can be as much as forty times more expensive than the lowest-priced generic medicine. [5]
• According to an inquiry by the European Commission, in the period 2000 to 2007, it took more than seven months after patent expiry for cheaper generic medicines to become available on the market in 17 European Union Member States, thus delaying the 20% savings to the health system. [6]
• In the European Union, up to 1300 patents can be filed in relation to a single product – a practice called patent clustering, which creates a dense web of protection around products and hampers generic competition. [7]

Rational use

• The WHO Model List of Essential Medicines has been updated every two years since 1977. The current version, the 16th list, as well as the 2nd WHO Model List of Medicines for Children, dates from March 2009. The Model List is a guide for the development of national and institutional essential medicine lists.
• The use and misuse of antimicrobials in human medicine and animal husbandry over the past 70 years has led to a relentless rise in the number and types of microorganisms resistant to these medicines.
• Consumption of anti-bacterial medicines in Denmark (expressed in defined daily doses per 1,000 inhabitants per day) increased by 31% from 1999 to 2008, and Denmark is one of the countries that consumes the least quantities of antibiotics. In 2008, 308 out of 1,000 Danes received at least one prescription of anti-bacterial agents in primary health care. Research shows that this increase cannot be explained solely by the increasing age of the population or epidemiological factors.[8]

Regulation and quality

• Effective medicines regulation promotes and protects public health by ensuring that medicines are of the required quality, safety and efficacy; medicines are appropriately manufactured, stored, distributed and dispensed; illegal manufacturing and trade are detected and adequately sanctioned; health professionals and patients have the necessary information to enable them to use medicines rationally; promotion and adverting is fair, balanced and aimed at rational drug use; and access to medicines is not hindered by unjustified regulatory work.
• The European Commission, the European Medicines Agency and the national regulatory authorities in all European Union Member States have developed and implemented a comprehensive medicines regulatory network and framework.
• The role of WHO in the area of medicines regulatory support is two-fold. One aspect relates to the development of internationally recognized norms, standards and guidelines. The second aspect relates to providing guidance, technical assistance and training in order to enable countries to implement global guidelines to meet their specific medicines regulatory environment and needs.
• A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products, and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.
• Counterfeiting is greatest in regions where regulatory and enforcement systems for medicines are weakest. In most industrialized countries with effective regulatory systems and markets the incidence of counterfeit medicines is extremely low – less than 1% of market value according to the estimates of the countries concerned. But in many other countries a much higher percentage of the medicines on sale may be counterfeit. [9]
• In many countries, Internet-based sales of medicines are a major source of counterfeits, threatening those who seek cheaper, stigmatized or unauthorized treatments. Some Internet pharmacies are legal operations, set up to offer clients convenience and savings. They require patient prescriptions and deliver medications from government-licensed facilities. Illegal Internet pharmacies conceal their real identity, are operated internationally, sell medications without prescriptions, and deliver products with unknown and unpredictable origins or history. [10]