Authorisation of medicines and medical devices
All medicinal products for commercial human use in the European Union are authorised by the EU or a Member State before they enter the European single market. To be authorized, they need to comply with the good manufacturing practice guidelines applicable within the European Economic Area. Medicinal products are then monitored throughout their lifespan to guarantee that in the case of adverse reaction or unacceptable risk, they can be quickly withdrawn from the market. This is done through the EU system of pharmacovigilance.
Through the European Medicines Agency (EMA) the EU coordinates the scientific evaluation of the quality, safety and efficacy of medicinal products and provides scientific advice to ensure the highest possible level of public health protection. Since 2010, EFA has been a member of the Patients and Consumers Working Party ofEMA. We are closely involved in EMA activities to bring the patient perspective toasthma, allergy and COPD medicines.
Medicines
In the 1800’s, early drugs were derived from plants and supplemented by animal materials and minerals. These drugs were mainly discovered through a combination of trial and error experimentation, observation of human and animal reactions and they were the only available treatments until recent times. Scientific techniques to drug discovery and development began in the 1900s.
From then onwards, more and more drugs were discovered, tested and synthesized in large-scale manufacturing plants. But drugs are not ordinary consumer products. In most instances, consumers are not in a position to decide when to use drugs, or which drugs to use, how to use them and to weigh potential benefits against risks. No medicine is completely safe. Professional advice from prescribers or dispensers is necessary in making these decisions.
As end-users of medicines, we at EFA advocate for:
- Improved involvement of patients in all decisions influencing their health, especially when it comes to risk-benefit analysis and safety;
- Stricter controls that guarantee the safety of the medicines entering the EU single market.
Medical devices
Medical devices cover a large spectrum of products. In particular, for patients with chronic disease, medical devices are fundamental as they can increase life expectancy and quality of life.
Inhalers, nebulisers and adrenaline injectors are widely used medical devices for asthma and COPD patients. In case of anaphylaxis, the lives of patients with allergies can be saved thanks to a medical device that injects epinephrine into their bodies.
Medical devices are of great importance for people living with allergy and airways diseases. At EFA we therefore advocate for:
- Stricter regulation with increased patient-involvement in medical devices that ensures patient safety above market conditions;
- m-Health solutions to be considered in certain cases as medical devices;
- Systematic quality-check and control of medical device components with greater transparency and information provided to the public.
Pharmacovigilance in the European Union
All medicinal products for human use commercial in the European Union are authorised either by the European Commission or a Member State before they enter the European single market. To be authorised, they need to comply with the good manufacturing practice guidelines applicable within the European Economic Area. Medicinal products are then monitored throughout their lifespan to guarantee that in the case of adverse reaction or unacceptable risk they can be quickly withdrawn from the market. This is done through the EU system of pharmacovigilance.
Personalised Medicine
Personalised medicine is an emerging medical approach that enables taking tailored medical decisions, practices, interventions and products to individual patients according to their predicted responses to treatment or risk of developing a disease. The approach suggests shifting attention from diseases to individuals, focusing more on patient-specific elements such as lifestyle and environment.
Apart from better health outcomes and a more cost-effective use of healthcare, personalized medicine promises patients a better management of health by granting access to information about disease prevention and treatment. Asthma and allergies have served as pilot diseases for the development of personalized medicine, due to their complex nature.
Welcoming this evolution of healthcare systems, EFA highlights the potential of personalized medicine to give patients timely and equal access to their treatments. Therefore, our aim is to ensure that the process from general healthcare to personalised treatment is open and participatory for patients.