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The OTC Pharmaceutical Market in Emerging Countries
From: Business Insight
The global OTC pharmaceutical market
The over-the-counter (OTC) pharmaceutical market includes non-prescription medicines that are sold directly to consumers through pharmacies, drugstores, convenience stores and grocery stores. The market is also referred to as the non-prescription drugs and self-medication market. The OTC market includes the total sales generated from analgesics, cough treatments, cold and allergy medicines, digestive remedies, vitamins and minerals, traditional medicines and others including smoking cessation products, sleeping aids, obesity drugs, medicated skin care , topical OTC medicines, plasters and bandages.
According to the US Food and Drug Administration (FDA, the US regulatory body), OTC medicines must have the following characteristics:
- The benefits should offset the risks associated with the medicine.
- The medicine should be adequately labeled.
- The medicine should be for the conditions which a consumer is able to self-diagnose, self-treat and self-manage, thus curbing the need for health practitioners for the safe and effective use of the product.
OTC medicines play an important role in the healthcare system, as they provide easy access to medication for minor diseases. More than 100,000 OTC products are marketed in the US alone, with about 800 significant active ingredients.
Most countries follow the ‘two-class system’ for the classification of medicines as prescription (Rx) or non-prescription (OTC). However, some countries further divide these two classes, such as pharmacy-only (behind the counter), pharmacy self-selection or general sale through any retail outlet. There is no stringent regulation on the price controls of these medicines in most countries.
Each country has its own regulatory body which governs the OTC pharmaceutical market in that respective geography. The regulatory bodies in the US, five major European markets (5EU; France, Germany, Italy, Spain and the UK) and Japan are shown in Figure 1 below.
Figure 1: Regulatory bodies in major markets
Source: Business Insights
The FDA’s Center for Drug Evaluation and Research (CDER) regulates all drug products in the US, including OTC medicines, prescription drugs, generic drugs, toothpaste and cosmetics. For a product to be classified as OTC in the US there are two regulatory pathways: an OTC drug monograph or an OTC New Drug Application (NDA). The Division of Non-prescription Regulation Development (DNRD) is responsible for the development of OTC drug monographs, which list the ingredients, dosage, formulations and instructions of use.
An NDA route is applicable if there are no existing monographs for the drug, or if the manufacturer seeks to market a new OTC product or is applying for an RX-to-OTC switch. For Rx-to-OTC switching, the guidelines are very strict to ensure that the OTC product has an appropriate dosage formulation.
Unlike some European countries, OTC drugs are generally non-reimbursable for consumers in the US. Most of the US population is covered by private health insurance, with managed care provided by health management organizations (HMOs) and preferred provider organizations (PPOs).
The Medicines and Healthcare Products Regulatory Agency (MHRA) is a government body that regulates medicines in the UK, while the Medicines Act 1968 and Directive 2001/83/EC control the supply and distribution of medicines. The classification of medicines in the UK is as follows:
- Prescription only medicines – available only through prescription.
- Pharmacy – available under the supervision of a pharmacist.
- General sale list – available in general retail outlets such as supermarkets.
Pharmacy and general sale list medicines are OTC products which may be advertised to consumers. There is no pricing regulation on either class, although they are non-reimbursable. The UK government also introduced the Better Regulation of OTC Medicines Initiative (BROMI) with a view to better regulate the OTC market.
In Germany, both the federal and state governments have legislative powers to regulate the OTC market. At the federal level, the Federal Ministry of Health is responsible for implementing an overall legislative framework for all health-related issues. The responsibility for implementing federal legislation and supervising subordinate authorities and the medical profession lies with the state government, while the German Drug Law regulates the manufacturing and trade of pharmaceutical medications.
In Germany, OTC products are classified as pharmacy-only or general sale. There are no price controls and most are non-reimbursable. Consumer advertising is permitted.
The French Agency for the Safety of Health Products (AFSSAPS; Agence Française de Sécurité Sanitaire des Produits de Santé) is the regulatory body that decides which products can be sold as OTC in France. Drugs can be classified as follows:
- Ethicals – these include medicines that are prescribed and reimbursed.
- Semi-ethicals – these include medicines that are prescribed and reimbursable, but may be purchased without seeking a reimbursement.
- OTC – these include medicines that can be bought without a prescription but which are non-reimbursable. OTC drugs are free from price controls and the most of them are classified as ‘grand public’, which means that consumer advertising is permitted.
The Spanish National Health Service regulates the OTC medicines market in Spain. OTC products (especialidades farmacéuticas publicitarias; EFPs) are free from price controls and are non-reimbursable. Consumer advertising is permitted for all OTC products, although sales are restricted to pharmacies.
The Ministry of Health regulates OTC medicines in Italy. OTC medicines are classified either as farmaci di automedicazione or SOP (i.e. farmaci senza obbligo di prescrizione). Products may be sold in the mass market (e.g. in supermarkets) only if a pharmacist is present. Mass-media advertising is permitted for OTC products but not for SOP. There are no price control regulations for either type of products and both are non-reimbursable.
The Ministry of Health, Labour and Welfare (MHLW) administers the Pharmaceutical Affairs Law (PAL) which is responsible for the quality, efficacy and safety of drugs, quasi-drugs, cosmetics and medical devices in Japan. The PAL was introduced in 1943 and has been revised several times since. The OTC market in Japan is strictly regulated, with OTC sales permitted only through pharmacies. However, in 2009, the PAL was amended to classify OTC drugs into three categories according to the risks involved, which are as follows;
- Type 1 – comprises OTC products which are considered to have a very high risk, for instance gastrointestinal products (antacid).
- Type 2 – comprises OTC products which are considered to have a relatively high risk and includes cold remedies, analgesics and antipyretics.
- Type 3 – comprises OTC products which are considered to have a relatively low risk, such as minerals and vitamins.
Type 2 and 3 are permitted to be sold through supermarkets and hypermarkets, although they can only be dispensed by a registered sales person. Moreover, OTC products sold in the supermarkets and hypermarkets must be displayed separate from other merchandise.
In 2009, the global pharmaceutical market reached $752bn, witnessing year-on-year growth of 3.4%, while the global OTC pharmaceutical market reached $113bn (having shown year-on-year growth of around 4%). The growing economy, increased consumer awareness about preventive medication, the imminent patent expiries of blockbuster drugs, and a relaxation in the regulatory procedures for Rx-to-OTC switches all fuel the growth of the global OTC market. In 2009, the US and Europe together accounted for over 60% of global OTC sales. However, OTC markets in emerging countries—particularly China and Eastern Europe—have shown more growth than the developed markets of North America and Europe. Indeed, in these developed countries, the OTC market is becoming mature with little or no scope for innovation in terms of new ingredients/products. In the US, the UK and Germany, growth is due to Rx-to-OTC switches, while growth in other regions is attributable to new distribution channels and the easing of advertising restrictions.
Pharmacy and drugstore sales accounted for over 67% of the global OTC pharmaceutical market in 2009. This trend is expected to continue in the near future, as the FDA is considering adding a behind-the-counter (BTC) classification for medicines in the US. BTC represents medicines which could be sold without a prescription but under the direct supervision of the pharmacist.
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