A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Acquis Communautaire
The acquis communautaire comprises the common set of laws and acts adopted by the European Union since the outset. It is, in some way, the contract to which the EU-25 Member States subscribe and represents an estimated total amount of 80,000 pages legislation.

Adherence
The extent to which the patient follows medical instructions and takes prescribed medicines according to treatment recommendation. In developed countries, adherence to long-term therapies in the general population is around 50% and much lower in developing countries.

ADR - Adverse Drug Reaction
A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy for diseases or for modification of physiological function.

Antimicrobial resistance
The use of anti-microbial medicines (i.e. any substance used to kill or inhibit the growth of micro-organism, including antibiotics and other antibacterials, antiviral, antifungal and antiparasitical agents) has greatly contributed to improvements in health, in treating communicable diseases and preventing infections. However, overuse and misuse of antibiotics (especially in children with respiratory infections) have favoured the growth of resistant organisms. The emergence and spread of antimicrobial resistance has become a major public health problem, within the EU and world-wide.

ATC
Anatomic, therapeutic, chemical. International system for classification of medicines.

ATC/DDD
Anatomical Therapeutic Clinical Classification/Defined Daily Dose

Attrition Rate
Refers to the rate of new chemical entities that are dropped out of the three phases of clinical trials. For example out of 100 new chemical entities, 25% will drop out at phase I, of the 75 that remain for phase II, 52% would drop out. Of the 36 that remain for phase III, 36% would drop out that phase, leaving about 23 of the orginal 100 new chemical entities that actually made it through the process.

Benchmarking
Benchmarking is the search for industry best practices that will lead to superior performance.

Biotechnology
Biotechnology is used in two ways: first it describes the traditional biological methods which living organisms use to produce or modify chemical compounds (e.g. antibiotics and vitamins). Secondly, it includes gene technology, which is based on the ability to isolate, replicate, cut and recombine DNA and to transfer DNA from one cell to another. Organisms whose genetic material has been altered in a way that does not occur naturally are called genetically modified organisms (GMOs).

Blockbuster
Refers to a drug which generates over $ 1 billion in global sales.

Bolar
In the US, the "Roche versus Bolar" amendment to the Watchman-Hatch Act (1984) allows generic medicines manufacturers to use a patented product, before its patent expires, in the preparation of their marketing authorisation application. This amendment was part of the political balance reached when agreeing on measures to restore effective patent protection in the USA. In Europe, this balance was reached by limiting, in the SPC regulation, the effective marketing authorisation to a maximum of 15 years. Introducing a Bolar provision (also called "early working") in Europe would go against this equilibrium.

Cadreac - Collaboration Agreement between Drug Regulatory Authorities in European Union Associated Countries
Informal voluntary co-operation of drug regulatory authorities of accessing countries, represented by their directors, that should help to prepare the area of drug regulation for accession to the European Union.

Cell
The cell is the basic unit of all living organisms. Some living organisms exist only as a single cell. This is the case for bacteria , as well as certain animals and plants. An average sized man contains from 60 to 100 trillion cells. Cells nourish themselves, produce energy, exchange information with their neighbours, multiply, and eventually die when their time has come.

Centralised Procedure
Since 1995, medicinal products can be assessed via the Centralised procedure. Medicinal products that have been approved via this procedure are issued a marketing authorisation that is valid throughout the EU. This marketing authorisation is granted by the European Commission. The use of this procedure is compulsory for medicinal products derived from a biotechnological process. For other innovative products, such as products with a new active substance, a company can choose whether to follow this procedure or the Mutual recognition procedure. In the case of the Centralised procedure, a dossier must be submitted to the European Agency for the Evaluation of Medicinal Products (EMEA) in London.

Clinical Trials
A clinical trial is a research study conducted in human participants to evaluate the safety and efficacy of a medicine to improve patient's health. Clinical trials conducted on new medicines and sponsored by pharmaceutical companies can only be started after a compound has survived rigorous pre-clinical development work, which involves laboratory testing (chemical/biological/pharmacological/toxicological). It is only when these tests show favourable and promising results that a company can proceed to assess the medicine in humans.

Committee for Medicinal Products for Human Use - CHMP
Within the European Agency for the Evaluation of Medicinal Products (EMEA), the Committee for Proprietary Medicinal Products is the scientific committee responsible for preparing the Agency's opinions on questions relating to the evaluation of medicinal products for human use. It is made up of 30 members nominated by the Member States.

Compassionate Use
Refers to situations where a drug is provided to a patient on humanitarian grounds prior to the drug's receiving regulatory approval.

Compulsory Licensing
The TRIPS agreement provides strict conditions under which governments can allow the production or sale of a product without the permission of the patent holder (for example in cases of extreme urgency).

Counterfeit pharmaceutical (WHO definition)
(A fake medicine) which is deliberately and fraudulently mislabelled with respect to identity and/ or source. The term counterfeiting can apply to both branded and generic products, and counterfeit products may include products:
1) with the correct ingredients;
2) with wrong ingredients;
3) without active ingredient;
4) with incorrect quantity of active ingredient; or
5) with fake packaging.”

CRO (Clinical Research Organisation)
Organisation which provides services to the pharmaceutical industry and specialised in the conduct of clinical trials.

DALY
Disability-Adjusted Life Year( DALY) measures overall burden of a disease by combining the year of potential life lost due to premature death and the year of productive life lost due to the disability.One DALY is one lost year of healthy life.

Data Exclusivity (also referred to as Data Protection)
Pharmaceutical registration data are the proprietary (i.e. confidential) data generated by scientific research conducted to demonstrate the efficacy and safety of new medicines and submitted to regulatory authorities for marketing approval. Data protection periods refer to the period of time during which a company is able to keep its rights for clinical data related to a given medical product, without another company being able to use that data when applying for an authorisation to market a generic medical product. Data exclusivity is an independent intellectual property right, subject to protection under Article 39.3 of the TRIPs Agreement.

Data Privacy
Individually identifiable information, e.g. medical background and personal health data, that may not be disclosed or transferred inappropriately without the explicit authorisation of the individual.

Differential Pricing
Sometimes referred to a "tiered pricing", "equity pricing" or "preferential pricing". They all refer to the same principle of adapting prices to purchasing power of the world's poorest countries.

Disease
An alteration in the state of the body or of some of its organs, interrupting or disturbing the performance of the vital functions.

Doha Declaration
Refers to the "Declaration on the TRIPS Agreement and Public Health", adopted on 14 November 2001 at the Doha (Qatar) Ministerial conference of the World Trade Organization. It is a political commitment of all WTO members governments to the TRIPS Agreement which further clarifies the flexibility already available under TRIPS, enabling developing countries to address national health emergencies.

DTCI - Direct-to-Consumer Information
In contrast with Direct-to-Consumer Advertising (DTCA) which is forbidden in Europe, the pharmaceutical industry considers that all patients should have the same right to truthful, accurate and easily understandable information that enables them, in consultation with their doctors, to make well-informed choices about their health. Europeans should have access to quality medicine information from all sources, including from pharmaceutical companies (see "information to patients").

EDL
EDL (Essential Drugs List
The WHO Model List of Essential Drugs was developed in the 1970s to stimulate the rational availability of medicines in developing countries. Essential Drugs are those that meet the health needs of the majority of the population. They should be available at all times in adequate amounts and in appropriate dosage forms. The WHO Model List of Essential Drugs enables developing countries to indentify priorities and make their own drug selection. It is to be noted that over 90% of the essential drugs contained in the WHO Model List are off-patent and can therefore be legally copied, at virtually no cost, by generic companies.

EMEA
EMEA (European Agency for the Evaluation of Medicinal Products)
The European Agency for the Evaluation of Medicinal Products, now called European Medicines Agency, began its activities in 1995. Based in London, the Agency coordinates the existing scientific resources of the Member States in order to evaluate and supervise medicinal products for both human and veterinary use throughout the European Union.

EPAR
European Public Assessment Report - Reflects the scientific conclusion reached by the Committee for Proprietary Medicinal Products (CPMP) at the end of the centralised evaluation process and provides a summary of the grounds for the CPMP opinion in favour of granting a marketing authorisation for a specific medicinal product.

Epidemic
A widespread occurence of a disease affecting many persons simultaneously in a community or area.

GATT (General Agreement on Tariffs and Trade)
A comprehensive free-trade treaty signed in 1947 by 117 nations, including almost every developed country. The goal of GATT has been to promote global economic growth by encouraging and regulating world trade. Among other things, member countries are required to treat all other member countries equally in the application of import and export tariffs, offer basic copyright protection to authors from member countries, consult with each other about trade matters and attempt to resolve differences in a peaceful manner. GATT created an international regulatory body known as the World Trade Organization (WTO) to enforce compliance with the agreement.

Generic
An off-patent medicine. Until the patent expires, only the company that discovered a new medicine may produce it. After patent expiry any company may produce the same generic compound.

Genes
Genes are formed from DNA, carried on the chromosomes and are responsible for the inherited characteristics that distinguish one individual from another. Each human individual has an estimated 100,000 separate genes. More generally the term 'gene' may be used in relation to the transmission and inheritance of particular identifiable traits.

Gene Therapy
The replacement of a defective gene in an organism suffering from a genetic disease. Recombinant DNA techniques are used to isolate the functioning gene and insert it into cells. Over 300 single-gene genetic disorders have been identified in humans. A significant percentage of these may be amenable to gene therapy.

Genome
The total set of genes carried by an individual or cell.

Genomics
The study of genes and their function. Recent advances in genomics are bringing about a revolution in our understanding of the molecular mechanisms of disease, including the complex interplay of genetic and environmental factors. Genomics is also stimulating the discovery of breakthrough healthcare products by revealing thousands of new biological targets for the development of drugs, and by giving scientists innovative ways to design new drugs, vaccines and DNA diagnostics. Genomics-based therapeutics include "traditional" small chemical drugs, protein drugs, and potentially gene therapy.

GCP (Good Clinical Practice)
International ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

GMP (Good Manufacturing Practice)
Under this regulation, all pharmaceutical manufacturing companies in Europe are required to comply with rules setting controls over manufacturing processes and inspections of manufacturing sites.

Hatch-Waxman Act
In the US, the Hatch-Waxman Act (1984) struck a balance by making generic drugs more widely available and continuing incentives for pioneer companies to develop new drugs. Generic companies have a limited right to infringe on a patent, so they can get an early start on the approval process. Since the law's passage, the generic drugs' share of the market has grown to nearly 50 percent.

Health - WHO definition
Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. Article 152 ofthe Treaty on the European Union states that a "high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities".

Health Outcome
Changes in health status (mortality and morbidity) which result from the provision of health (or other) services.

Health Outcomes Research
Refers to a discipline/methodology to assess the value added - including direct, indirect and intangible benefits - of a particular medicine. Industry considers that such considerations (also referred to as "pharmacoeconomics" or "cost-effectiveness studies") are not appropriate in the marketing approval process which must focus solely upon quality, safety and efficacy.

HMO (Health Maintenance Organization)
Is a health plan that is also involved in how your health care is delivered. Managed care refers to health plans coordinating your health care with you and the providers that participate in the health plan. HMOs are the most common type of managed care.

Hormone
A hormone is a molecule produced by a gland or tissue. Usually transported by the blood, a hormone affects an organ or other tissue located at a distance. For example, the pancreas produces insulin, which regulates the level of sugar throughout the organism. Hormones are “messengers” that, in concert with the nervous system, coordinate the activities of billions of cells in the human body.

ICH (International Conference on Harmonisation)
ICH
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. The purpose is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration.

Incidence
The number of new patients affected by the disease per annum

Informed consent
The concept of informed consent (required to participate in clinical trials) is based on the principle that a physician/doctor has the duty to disclose to a patient information (e.g. potential risks, benefits and alternatives) that allows the patient to make reasonable decision regarding his or her participation in a clinical study.

INN
When a molecule is shown to have some useful activity, it is given an international non-proprietary name (INN), based on internationally agreed rules, which is submitted for approval to a special committee at the World Health Organisation.

Innovation
Technological progress that leads to the creation of an entirely new product (product innovation) or a reduction in the cost of producing (process innovation) or an increase in the therapeutic value of an existing product for patients. Innovations can lead to new active substances, new indications for existing products or new ways of administering the same product.

International Exhaustion of International Property Rights
A theory which is based on the territoriality of rights and implies that after the legitimate first sale of a protected good in a country anywhere in the world, the owner of the intellectual property right on this product loses his right to restrict its (re-)exportation in any other country.
In Europe, international exhaustion is not in place and the current Community-wide exhaustion regime for trademarks allows trademarks holders in the EU to ban imports of branded goods from outside the territory of the EU into the Community. The same situation prevails for patented goods.
By contrast, the EU authorities consider the European Union as a single and unified territory where protected goods can freely circulate between the Member States. Consequently, parallel import is allowed within the territory of the EU.

IPRs (Intellectual Property Rights)
The area of law that regulates the ownership and use of creative works, including patent, copyright and trademark law. Intellectual property rights have been developed to protect creative people who have disclosed their work for the benefit of humankind from having it copied or imitated without their consent.

LDC
Least Developed Countries (currently 49 countries).
Developing countries are distributed under income groups : high income, middle income, low income (see UNCTAD)

Medicinal Product
Under EU law a medicinal product is defined as any substance or combination of substances presented for treating or preventing diseases in human beings or animals. Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product. See Directive 2001/83/EEC amending directive 65/65/EEC setting out the framework of the pharmaceutical regulation.

MedDRAMedDRA
Medical Dictionary for Regulatory Activities Terminology. This critical medical resource, was developed by the International Conference on Harmonisation (ICH) and is owned by the International Federation of Pharmaceutical Manufacturers Association (IFPMA). By providing one source of medical terminology, MedDRA improves the effectiveness and transparency of medical product regulation worldwide.

MEP
Member of the European Parliament

Millennium Development Goals (MDGs)
The Millennnium Development Goals (MDGs), adopted at the Millennium Summit of the United Nations in September 2000, call for a dramatic reduction in poverty and marked improvements in the health of the poor. The goals and targets represent a partnership between the developed countries determined to "create an environment which is conducive to development and the elimination of poverty"

Monopsomy
A situation in which the entire market demand for a product or service consists of only one buyer

Morbidity
The relative incidence of a particular disease in a specific locality

Mortality
Number of deaths in a given period

Mutual Recognition
Under this procedure a marketing authorisation granted by one Member State is extended to one or more other Member States selected by the applicant. This procedure applies to the majority of conventional medicines.

NGO
Non Governemental Organisation

NMEs
New molecular entities: products (including new chemical entities (NCEs), biological products, vaccines and products of biotechnology) that have not been previously available for therapeutic use in humans and are destined to be made available as prescription-only medicine, to be used for the cure, alleviation, treatement, prevention or in vivo diagnosis of diseases in humans.

ODA
Official Development Assistance

Orphan Drug
A drug which only has a limited target population or which treats a rare disease thus limiting its commercial and financial potential. First enacted in the US (in 1983), the Orphan Drug Act was developed to help these patients and provides incentives (a period of market exclusivity and a tax credit for research expenses) to help make it commercially feasible to develop these drugs. In Europe, the Orphan Medicinal Product Regulation was adopted much later (in December 1999), to stimulate the development in the EU of pharmaceuticals for the diagnosis, prevention and treatment of some 5,000 diseases that are classified as "rare" and affect not more than 5 in 10,000 persons in the European union.

OTC (Over the counter)
A medicine available without a prescription.

Outpatient Care
Medical services that are provided without the need for an overnight stay in a hospital, such as through an ambulatory care clinic or emergency department.

Pandemic
Disease affecting persons over a wide geographical area (extensively epidemic).

Parallel Trade
Parallel trade is the purchase of goods at low prices in one country and the subsequent resale of those goods at higher prices in another country.

Patent
A patent is a legal, public document granting an intellectual property right to the patent holder. At the same time the information relating to the invention is made public, thereby enhancing the public good and protecting the rights of the inventor. In exchange for publication of his or her patent, the inventor is rewarded a limited monopoly allowing the patent holder to prevent others from making, using or selling the patented product. The monopoly is limited as to time (now 20 years from the date of filing of the patent application) and by national boundaries (where the patent has been granted). Patents for inventions are granted only if three conditions are met : Novelty, industrial applicability and inventive step.

Pharmacodynamics
Deals with the influence of genes on the interactions between medicines and their molecular targets.

Pharmacogenetics
Describes the influence of genes on the efficacy and side effects of medicines.

Pharmacogenomics
Studies interactions between medicines and the genome.

Pharmacokinetics
Investigates the update, conversion and breakdown of medicines in the body overtime. Environmental factors, diet and genetic predisposition all play a role.

Pharmacology
Pharmacology is a broad discipline encompassing all aspects of the study of drugs, including their discovery, development and actions.

Pharmacovigilance
Refers to the careful monitoring and continuous surveillance of the safety of an authorised medicinal product during its life on the market.

PIL - Patient Information Leaflet
Provides a set of information, in a particular order, accompanying each medicine. It is usually the only source of information on how to use a medicine safely and effectively, when the patient actually takes the medicine.

PIM - Product Information Management
PIM is a project that was initiated in 1999 to develop a new way of handling product information. Its membership has been drawn from EMEA, Member State competent authorities and EFPIA members. It has gone through several phases, which have culminated in the publication of the PIM standard. Should you need more information please visit the EMEA website at http://pim.emea.eu.int/whatispim.htm

Prevalence
The percentage of population which is affected by a disease

Primary Care
The "medical home" for a patient, ideally providing continuity and integration of health care. All family physicians and most pediatricians and internists are in primary care. The aims of primary care are to provide the patient with a broad spectrum of care, both preventive and curative, over a period of time and to coordinate all of the care the patient receives.

Proteins
Proteins are formed by connecting much smaller molecules, amino acids , into a chain. Some proteins contain a few tens of amino acids while others are made of thousands. Each protein has a characteristic structure that depends on the order of its amino acids and the manner in which the chain folds in space. This structure determines the function of the protein: transport function (haemoglobin transports oxygen by way of the blood), defence against microorganisms (antibodies), hormonal activity (insulin, adrenalin, etc.), activation of biochemical reactions within cells ( enzymes ), and many others.

Proteomics
Proteomics is the systematic analysis of all protein sequences and protein expression patterns in tissues, which involves the isolation, separation, identification and functional characterization of all of the proteins in an organism. Genes encode proteins that perform all of the fundamental activities within cells. Proteins transmit messages, repair damage, provide the building blocks for tissues and carry out reactions essential for life. Proteins are the molecular machines that carry out genetic instructions. Abnormalities in protein production or function have been connected to many diseases and health conditions. To understand how best to treat a particular disease, it is necessary to identify the proteins associated with that disease and to understand how they function.

Public Health
Public health is covered by Article 152 of the EC Treaty, which was introduced by the Treaty of Maastricht. This article states that Community action is to focus on the prevention of illnesses, including drug addiction, by promoting research into their causes and their transmission, as well as health information and education. The Treaty of Amsterdam reinforces these objectives by requiring that the definition and implementation of all Community policies and activities ensures a high level of human health protection. Under Article 152 action towards these ends may involve Community measures, complementing action by the Member States. But the main approach should be to encourage cooperation between the Member States, in line with the subsidiarity principle.

Reference Pricing
The practice of setting the price and/or reimbursement level of medicines according to the price set in other EU Member States. Such practice undermines price competition and jeopardizes incentives for innovation and R&D. Mixing patented and off-patent medicines in the same category of reference pricing is even worse because it prevents price competition both among generics and branded medicines, rewards imitation, and penalizes innovation.

Rx
Prescription medicine (in the US)

Secondary care
Secondary care is the term for care in hospital

Serendipity
The faculty of making fortunate discoveries by accident

SITC
Standard International Trade Classification

SMEs
Small and medium size enterprises

SmPC (Summary of Product Characteristics)
In order for a medicinal product to be evaluated either by the competent authorities of Member States or by the EMEA, a company must submit a dossier. This dossier, which in terms of content and presentation must comply with current European guidelines (Directive 65/65/EEC amended by Directive 83/570/EEC), is comprised of four parts. The first part contains administrative information and a summary of the dossier, which includes the Summary of Product Characteristics. In European jargon, this information is usually referred to as the SPC or SmPC, which forms an intrinsic and integral part of the marketing authorisation.

SPC (Supplementary Protection Certificate)
The SPC applies to pharmaceutical products and was brought into effect by Regulation in the European Union on January 2 1993. The SPC has a maximum term of 5 years to give a maximum effective patent life of 15 years from the date on which a product is authorized for first marketing in a EU country.

Stem cell
Stem cells are unspecialized “master” cells that differ from other kinds of cells in the human body in that they have a unique capacity to multiply and differentiate into many types of specialized cells and tissues. Stem cells exist at all stages of human development from early embryos to foetuses to adults. There are three types of stem cells: embryonic, foetal and adult. While the use of adult stem cells is well accepted and non-controversial, research into embryonic and foetal stem cells raises a number of ethical questions.

Subsidiarity Principle
It is a fundamental principle of European Union law. According to this principle, the EU may only act (i.e. make laws) where member states agree that action of individual countries is insufficient. The principle was established in the 1992 Treaty of Maastricht, and is contained within the proposed new Treaty establishing a constitution for Europe.

Transparency Committee
The Transparency Committee, established under Directive 89/105/EEC (and often referred to as "the Transparency Directive"), is made up of Member State representatives responsible for the pricing and reimbursement of pharmaceuticals and advises the Commission on matters relating to the Transparency Directive.

TRIPS (Trade-Related Aspects of Intellectual Property Rights)
The WTO TRIPS Agreement is a major achievement of the GATT's so-called "Uruguay Round", which sets up minimum international standards of intellectual property rights, including patents, and for enforcement of those rights, which each member of the WTO must incorporate into its national laws.

Vaccine
Refers to the introduction of vaccine - attenuated or killed micro-organisms (bacteria or viruses) - into the body for the purpose of inducing protective immunity against infectious diseases. Conventional prophylactic vaccines aim at stopping people becoming infected. Therapeutic vaccines are products that stimulate the immune system of people with chronic infection to eliminate the virus from their bodies. Vaccine preparations can be natural, synthetic or derived by recombinant DNA technology.

Virus
A microorganism smaller than a bacteria, which cannot grow or reproduce apart from a living cell. A virus invades living cells and uses their chemical machinery to keep itself alive and to replicate itself.

WHO (World Health Organisation)
Founded in 1948 with headquarters based in Geneva, the World Health Organisation is a specialised agency of the United Nations with 191 Member States, which promotes technical cooperation for health among nations, carries out programmes to control and eradicate disease and strives to improve the quality of human life.

WTO (World Trade Organisation)
Created by the Uruguay Round negotiations and established since 1 January 1995 in Geneva, the World Trade Organisation (WTO), with a membership of 153 governments, aims at being a place where member governments try to sort out the trade problems they face with each other.