The Role and Functions of the European Medicines Agency - Research Paper Example

REVIEW OF THE ROLE AND FUNCTIONS OF THE EUROPEAN MEDICINES AGENCY (EMA) IN THE CONTEXT OF BIOTECHNOLOGY DRUGS ABSTRACT This paper covers and in depth overview of the roles and functions of European Medicine Agency in relation to biotechnological drugs. The EMA has adopted the decentralized system of organization and corporation with other regulatory bodies. Their main concern is protecting public and animal health. They provide for and supervise medicines recommended for human and animal use. It has been heavily endowed with the responsibility to provide quality assurance and evaluation of biotechnological product through scientific research and advice to authorized bodies dealing in drugs. These include herbal medicine, biologics and advanced therapies in relation to human and veterinary therapies (European Medicines Agency. 13 September 2011). The agency is made up of a Secretariat (ca. 600 staff), a board of management, a total of 6 scientific committees (human, herbal and veterinary products, orphan drugs, pediatrics and advanced therapies) and a number of scientific working parties (European Medicines Agency. 13 September 2011).The organization is well structured into five units which are mutually related to each other in terms of operation and services. The EMA derives its resources from over forty National Competent Authorities and over 4500 experts from all over European Union countries(European Medicines Agency. 13 September 2011). Although the Community pharmaceutical legislation is based essentially on the Single Market provisions of the EU Treaty, the primary stakeholders obviously include patients and healthcare professionals who operate in quit different healthcare delivery systems (HMA Strategy Paper, 2007). While maintaining regular checks on the manufacturing of biotechnological products, the EMA agency provides for relevant advice to the pharmaceutical companies and caters for the public interest. The field of medicine is very sensitive area since it embodies the life of an individual and animals as well. Therefore, there has been a need to provide quality assessment in the medicinal field in order to ascertain safety, efficiency and quality in the process of manufacturing pharmaceuticals(HMA Strategy Paper, 2007). These requires detailed assessment by external body (EMA) which acts as autonomous body capable of carrying out its activities without the influence or engagement of political entities. Medicines are meant to improve quality of life; any deviation to the expected standards of requirement has devastating effect on the human and animal health. The European Medicine Agency therefore takes responsibility of ensuring such biotechnological drugs meet the market requirement before release into the market. This is inclusive of reports and recommendations provided by the agency with regard to good virtue of conduct that should be adopted by medical firms. INTRODUCTION The EMA is a regulatory body that seeks to monitor and evaluate biotechnological drugs to ensure consistency and quality. This is mainly with regard to human and veterinary health. It facilitates discussion across various regions in the EU with the objective of ensuring safety in biological drug production and uses .Biomarkers are widely used to ensure safety standards are followed in the processes of biotechnological drug production including from the time of invention to approval. The biomarkers data technology has been approved to be included in some specified products application in order to evaluate quality and viability of biotechnological drugs. The EMA regulatory body is entrusted with reliable data collection and dissemination on biotechnological drugs. This is an important role that has worked to solve challenges in the EU market with regard to policy implementation and execution. The EMA agency is also trusted with the critical information since it involves supervision and licensing biological products generated for the market in the European Union. There have been several organizations that provide similar services as the EMA due to the rising innovation of biotechnological drugs. Their main purpose is to regulate the market supply with biotechnological products (European Medicines Agency. 13 September 2011). EMA stands out from its organized structure right from the management body right to the very low level personnel. Its main objective is derived from the virtue of trust and quality assurance. BACKGROUND. The formation of agencies has featured since the late 1970s from the beginning of formation of Agencies. The earlier agencies were associated with Organizations that were meant to cater for the life improvement and living conditions of the stakeholders. This paper scrutinizes the development and evolution of agencies since the 1970s. The European agencies have gone through several phases of reform. The first one was majorly concerned with the legal characteristics of the agencies. The second phase majorly emphasized on the principle of analysis of the framework of the agencies. The third was more emphasized on the reform of the European Institutional structure. The EMA has since taken a different perspective of the traditional forms of agencies and now taking a different direction altogether. Its responsibility is mainly directed at solving human and animal health in relation to biotechnological drugs. Its establishment has made significance reforms in the quality health services. The formation of EMA was formed late in 1993 with the purpose of Evaluating medical products. It was established with a centralized structure where all medical regulations were administered by the agency. The agency also provided a marketing authorization for the medical market but with the commission still adopting the final and binding decision (Council Directive 87/22/EEC, 1986). Promoting and Protecting Public and animal Health This is the main objective of the European Medicine agency. It ensures distinction in scientific research with the mutual concept of benefiting the public and the animal health. It seeks to review the coordination and conducting survey on various scientific innovations put forward by researches and the member states. They offer advice to the European member state on the right course to take from its research and analysis of pharmaceutical products and scientific inventions. The examination is conducted according to the Medical Products Legislation in the European countries. Commission of Veterinary Medical Products The agency has formed a special committee which is committed to reviewing terms of veterinary service in European Nation. The committee was dubbed Committee for Medical Product for Veterinary (CVMP) (Heads of Medicine Agencies, 2007). The committee serves as the body responsible for validating veterinary medical products to ensure compliancy requirements. Quality, security and efficiency requirements must be established in the process of vetting biotechnological products. The final product of the biotechnological products must meet certain criteria before release into the market in order to reduce the risk factor to the animals Upon verification of the products as suitable for the market, the committee can then warrant sale of such drugs. The committee provides checks and balances on the existing market through assessment of modifications that may be made(Lisa, 2008 ) .They check the modifications against the set standards in order to pass the product as due to the market. The veterinary medicines “maximum residue limit ‘that is permissible in foods should be established before being released to the market (Lisa, 2008 ).These include products directly derived from animals. Advisory Groups Advisory groups have been set by the Commission for Veterinary Market Products (CVMP) to provide consultation on various fields in veterinary medicine. The advisory bodies specializes in specific area of study that they can provide reliable information. The information provided by the groups can be used to compile scientific documentation that can be used to access quality and suitability of the biotechnological drugs. The information provided by the Advisory bodies is resourceful in providing assistance to the researchers and pharmaceutical venturing in veterinary medicine. This helps the stakeholders in the veterinary medicine production synchronies their product quality with the requirements of the regulatory bodies. Current CVMP working parties include the Efficacy Working Party, Immunological Working Party, Joint CHMP /CVMP Quality Working Party, Pharmacovigilance Working Party, Safety Working Party, Scientific Advice Working Party and Environmental Risk Assessment Working Party (Council Directive 87/22/EEC, 1986 ).The Advisory Groups can also provide critical information that can be used to assess a particular type of biotechnological drugs or treatment. For instance, the Scientific Advisory Group on Antimicrobials (SAGAM) gives provides advice to the on all affairs that are directly related to antimicrobials and especially as pertains minimization of risks involved in development of any kind of resistance that might be associated to the use of the antimicrobials (Council Directive 87/22/EEC, 1986 ). The viability of Marketing Authorization Application The Market Authorization procedures applies to all biotechnological products and require such drugs to be reviewed under centralized system of checks. These are inclusive of veterinary medicine destined to treat animals or improve yields. For other medicines that do not fall under these categories, companies can submit an application for a centralized marketing authorization provided that the medicine constitutes a significant therapeutic, scientific or technical innovation, or for which centralized assessment is in any other respect in the interest of animal health (The Heads of Medicines Agencies Strategy Paper, 2007 ). For any application, a Reporter and Co-Reporter are appointed from the EMA’s members whose role is to lead the scientific evaluation and to prepare an assessment report (HMA Strategy Paper ,2007). The report is subjected to several checks in order to establish its suitability to the market while relevant modifications are implemented in the process. The agency employs a system of personnel that organizes and oversees the execution of the Application procedures. The agency closely works with at least four thousand experts that serve in the capacity of members of the scientific committee of the agency, working parties as well as the scientific assessment teams (Dehousse, 2006). The host of experience and expertise is provided by the vast European Union. The experts are not allied to any industry that deals in pharmaceutical either financially or by virtue of membership. To this end, the Agency has established a procedure and policy on the handling of potential conflicts of interest for Agency staff, scientific committee members and experts (Dehousse , 2006 ). Under normal circumstances, the committee usually gives their verdict in not more than 210 days. However, this period can be made significantly shorter in cases where expediency is of utmost importance. An example of such a scenario is when the product in question is in the interest of saving lives, animal health or even in therapeutic innovation cases ( European Medicines Agency. 13 September 2011 ). Constructive Approach to Assisting Companies. Scientific Based Assist The EMA adopts a scientific and revolutionary approach in trying to solve biotechnological products through intensive research and inventive assistance to companies. This includes relevant and viable scientific advice to industries in relation to standardized requirements. Scientific assistances can be adopted at the beginning of the process of establishment of a product in order to provide specific guidelines according to authorization principles. Scientific input may sometimes be requested to assist in interpreting of a given scientific aspect in a specific guideline (European Medicines Agency, 2011). In the recent past, there has been collaboration between the EMA and other regulatory body to incorporate the assessment standards in order to supply varying and dependable scientific access. This enables company’s dealing medical products to comply with varying requirements and regulations applicable in the real market situation The food and Drug Administration (FDA) offers parallel scientific advice, thereby increasing the chance of companies being able to follow a single development pathway that is bound to satisfy both regulators (European Medicines Agency, 2013) The agency provide for a dedicated units in its offices for particularly assisting in technical enquiry, efficient service delivery and inspection of the pharmaceutical products. The staff is small and dedicated to its functions where they can easily monitor medical products and compare the quality, efficiency and viability with authorization procedures. Through the research processes conducted by EMA, they have established relatively safe and reliable veterinary medicine that is suitable for improving animal performance and health. For instance, the agency has developed a policy to stimulate the development of new veterinary medicines for minor species and for rare diseases in major species (Council Directive 87/22/EEC, 1986 ). Once a veterinary product has been classified as falling within the scope of this procedure, then assistance with scientific advice, developing or extrapolating MRLs, and/or compiling a dossier for a marketing authorization may be provided Council Directive 87/22/EEC ,22 December 1986). Market Regulation Previously, the act of market regulation was majorly the responsibility of the government. This was enacted by government legislative laws. With time, the regulatory bodies such as EMA was formed to directly regulate the market structure for Pharmaceuticals. The EMA is now a self-regulating body that oversees quality, efficiency and compliancy in the markets for medical products. Since Directive 65/65/EEC, quality, safety and efficacy are the sole approval criteria for new medicines, with the assessment of applications representing the main element of the EMEA’s work ( HMA Strategy Paper ,2007 ). Under the centralized procedure, pharmaceutical companies submit a single marketing-authorization application to the EMA (HMA Strategy Paper ,2007).The regulatory body oversees the volatility of the applications and compares the specification against its set standards. The target market can either be considered in terms of human health and animal health. Biotechnological drugs produced targeting the market are first tested for efficiency and detailed report profiled by the agency authorization market for implementation. The authorization of biotechnological drugs must therefore pass through checks and regulation constituted in the EMA regulatory body before being considered suit for the market. The body has the capacity to recommend positive or negative note concerning a medicinal product. This helps shun out corruption that may arise due to external influence or dubious means of processing biotechnological drugs. This implies that the agency possess some indirect influence in market regulation. The structure of the agency is improvised in such a way that intrusion by external factors is almost impractical and therefore serves in the best interest of the public. Medicine Evaluation and Monitoring The EMA is responsible for coordinating the EU's safety-monitoring or 'pharmacovigilance' system for medicines (Fergus Sweeney, 2012 ).The EMA constantly monitors the performance of medicine with past modification and enact authority over Europe’s market. The EMA has a Pharmacovigilance Risk Assessment Committee (PRAC), which provides recommendations on the safety of human medicines ( Fergus Sweeney, 2012).The EMA has a Pharmacovigilance Risk Assessment Committee (PRAC), which provides recommendations on the safety of human medicines (HMA Strategy Paper ,2007 ). The medicine Evaluation works on the following basis to manage risk associated with pharmaceutical products. Setting standards and creating course of action to take. Setting objectives for pharmaceuticals companies to facilitate compliancy to given regulatory guidelines. Incorporating external authorities to the agency. Catering for the interest of health patients and public safety. The EMA is responsible for developing confidence among the public concerning safety use of medicine. The agency is also responsible for alerting the market on emerging pharmaceutical products and recommendations for those particular biotechnological products. It helps in providing for food safe limits for medicine residues in foods that come from animals (McCormick &John 2004 ).The EMA acts as the referral body which carries out scientific research on behalf of the European Union and provide results that can be relied upon in risk assessment of pharmaceutical product. Disagreements among Member States on the use of a medicine can also be referred to the EMA (McCormick &John 2004). Inspection Role The inspection role is entrusted with EMA across all states in Europe. The inspection ethics are based on: Good manufacturing practice (GMP) ( European Medicines Agency. 13 September 2011). Good clinical practice (GCP) ( European Medicines Agency. 13 September 2011). Good laboratory practice (GLP) ( European Medicines Agency. 13 September 2011). Pharmacovigilance (phV)( European Medicines Agency. 13 September 2011 ). EMA inspection covers various features of a laboratory and clinical testing. Inspections can also be performed in the context of the certification of vaccine antigen master files (VAMF) or plasma master files (PMF) ( European Medicines Agency. 13 September 2011). Metric Measures The liability of implementing the European Union’s metric measurement is entrusted to the EMA. The EMA regularly checks its database for the given set of requirements and compare them against the risk standards. The measurement metrics are helpful in ensuring quality in evaluation of risk assessment to provide regular updates and relevant information on particular medicine. Biotechnological drugs have become the new invention in the field of medicine and therefore it should be subjected to certain set of standard. The industry may be driven by the need to make profit and will therefore take less account of the effectiveness and quality of their medicinal products. The EMA agencies therefore provide certain measurement criteria that help determine efficacy and compliancy to a given set of performance metrics. The metrics can be established by committee of experts derived from the rest of Europe through scientific research establishments. Initiating Innovation The agency provides new ideas and medicinal advise to companies It publishes and avails the publication specifications for worthiness, security and efficiency testing of medicines. It offers special assistance to micro, small and medium-sized enterprises (SMEs) through its SME office (HMA Strategy Paper ,2007). Provides guidelines for scarce diseases i.e. orphan designation. It administers the inventive team work. The agency utilizes the varying range of experts across Europe that provides a host of experience and innovation in the field of biotechnological drugs. The main object being the need to improve the final product presented to the market authorization body. The scientific data provided by the agency can be relied upon during renovation of a particular drugs and necessary measures to be taken while improving such drugs. The innovative capability of the biotechnological drugs companies are complemented by the agency. In order to improve on existing product, researchers need to refer to set standards and previous data on the particular type of biotechnological products. This forms the basis of most research since improving on medicine requires detailed overview of the previous performance and implications to the health of the public. The AME network The agency works on creating relations with other agencies to globalize the requirements for pharmaceutical products. It aims at expending its network to adopt scientific expertise from varying parts of Europe and incorporate scientific ideas to provide the most efficient regulatory board all over Europe. The aim is to provide the best protection to human and animals. The EMA has now become an outstanding entity and independent from influence by third parties on its operation. Its objective is clearly driven by interest of the health of both human and animal in relation to biotechnological experts. The agency incorporates a host of experts that is experienced and knowledgeable in providing accurate and reliable scientific measurements on the performance and quality of biotechnological drugs in the European Union. Though the agency regulates the supervision of companies and related entities dealing in biotechnological drugs, it does not own any scientific laboratory specifically for scientific research. It therefore makes use of the available experts in the scientific research to carry out its laboratory test and evaluation of pharmaceutical products. The EMA does not cover all the medicines found in the whole of Europe. It merely supervises the category of drugs that falls within its authorization procedures. The mandate of monitoring such drugs that does not fall within EMA’s procedures is catered for by external bodies that are particularly interested in other fields. The joint appreciation and decentralized guidelines are administered by two coordinating entities that represent the European Union member states. The Agency can become involved in assessing nationally authorized medicines if they are referred to the EMA through a referral procedure must be considered (HMA Strategy Paper ,2007 ). This may result from the need to ensure safety and assurance in the provision of protective public health. Research and development work on medicines is carried out by pharmaceutical companies or other medicines developers themselves (Fergus Sweeney 2012 ). The result is submitted to the EMA for evaluation and analysis of the scientific research results provided by the companies. The EMA being an independent entity, it does not involve itself in providing finances to research. Funding role may alternatively be the concern of the companies dealing on production of biotechnological drugs and investors.   The EMA therefore purely specializes on the evaluation of efficiency, quality and viability of biotechnological drugs rather than carrying out scientific research and determining prices for the pharmaceutical products. An external organization called health-technology-assessment (HTA) bodies carries out its own assessment of medicine that has received marketing authorization (Heads of Medicine Agencies,2007 ). The HTA may also consider the price value of the pharmaceutical drugs in relation to legislative laws. It does not either determine the administration of such drugs by medical staffs. The agency is only concerned about providing scientific opinions but does not entirely issue or retract marketing authorization for the biotechnological drugs. Communication The interest of EMA is providing timely information to the public and to companies dealing in biotechnological drugs. The public may not be aware of the medicinal components but heavily relies on the medical practitioners who administer such drugs (Heads of Medicine Agencies, 2007 ). Though this may be true, in case of inefficiency or malfunctioning, the public may need to enquire about the prescribed drug. This provides some essence of quality and reassurance to the public that the medicine they have been prescribed meets the market standard. The information is derived from experts around the European Union countries who ventures into scientific research to ascertain excellence and effectiveness. CONCLUSION The revolutionary history of agencies started in the late 1970s. The requirements and amendments made over time have resulted to the emergence of new agencies with varying objectives and mission. The European Medicine Agency was established in the late 1993 has a result of rising concern over the biotechnological development of drugs. The agency is identified with research on pharmaceutical products in relation to human and veterinary health. This paper exclusively discusses the role and function of the European Medicine Agency in the world of evolutionary biotechnological drugs. Even though biotechnological drugs resolves human health problems, there is need to provide checks and balances in order to achieve quality and efficiency. Communication about this particular drugs are required by the market in order attach trust and satisfaction among the public. Violation of the medicinal ethics regarding veterinary medicine and human health may be disastrous and therefore EMA identifies these defects and provide guidelines or scientific solution in timely manner. This includes warning the public against certain defects of certain drugs and recommends terms of use for human and animals. The commissions formed within the EMA provide a divisive work structure where the organization is divided into commission and sub-commissions to provide detailed research results. The organization has incorporated other agencies in its system with the goal of providing wide variety of information on biotechnological products and increases the impact of assessment. The inclusion of other agencies also ensures market authorization is highly diversified to meet the current need of the human population and animal health. In general, the European Medicine Agency has provided improvement in the assessing quality, efficiency and quality across European countries. Through advanced scientific assessment, the agency has been able to provide relevant advice and scientific solutions to companies dealing in biotechnological medicine. References Council Directive 87/22/EEC, 1986. The approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology pd 34. Official Journal L 015 , 17/01/1987 P. 0038 – 0041 Dehousse R. 2006. Delegation of Powers in the European Union: The Need for a Multi- Principals Model. Discussion Paper Connex 2-9, available at: [Accessed 20th April 2014] European Medicines Agency. 2011. Committees, working parties and other groups Available at < http://www.ema.europa.eu> [Accessed 20th April 2014] Fergus Sweeney. 2012. WMA Workshop on revision of DoH, Capetown, South Africa. Heads of Medicine Agencies, 2007. The availability of veterinary medicines in the European Union found at http://www.hma.eu/204.html#c1197. [Accessed 20th April 2014] Lisa Waddington, 2008. The Internal Market and Disability Accessibility: Using EC Law to Establish an Internal Market in Disability Accessible Goods and Services. Maastricht Faculty of Law Working Paper No. 3. Available at [Accessed 20th April 2014] McCormick, John. 2004. The European Union: Politics and Policies. Boulder, Colo: Westview Press. HMA Strategy Paper, 2007. Developing the Heads of Medicines Agencies Strategy for the European Medicines Regulatory Network – A Discussion Document. Available at < http://www.hma.eu/fileadmin/dateien/HMA_joint/02- _HMA_Strategy_Annual_Reports/02- HMA_Strategy_Paper/Index/Section_II_HMA_Strategy_I_2007_11.pdf> [Accessed 20th April 2014] Read More