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RARE DISEASES AND MEDICAL DEVICES IN THE EUROPEAN UNION
Rare diseases have been identified as a priority area for Community action within the frameworkfor action in the field of public health. The European Parliament and the Council have adopteddecision No 1295/188/EC of 29 April 1999 adopting a program of Community action on rarediseases within the framework for action in the field of public health.
For the purpose of this program, rare diseases are defined as life threatening or chronicallydebilitating diseases, which are of such low prevalence that special combined efforts are neededto address them so as to prevent significant morbidity, perinatal or early mortality or aconsiderable reduction in an individual’s quality of life or socio-economic potential.
This low prevalence is generally recognised as being less than 5 per 10.000 in the Community.
Treatment options for rare diseases can include two types of products:
The Regulation (EC) N° 141/2000 of the European Parliament and of the Council on OrphanMedicinal Products was approved on December 16th, 1999 and published in the OfficialJournal of the European Communities on January the 22nd, 2000.
This new legislation is based on the fact that :
“some conditions occur so infrequently that the cost of developing and bringing to market amedicinal product to diagnose, prevent or treat the condition would not be recovered by theexpected sales of the medicinal product. The pharmaceutical industry would be unwilling todevelop the medicinal product under normal market conditions; these medicinal products arecalled "orphan"”.
The notion of social justice underpinning this legislation supports the concept that it is equallydesirable to advance effective treatments for individuals with rare disorders as for those withmore common conditions.
The EU Parliament has expressed in this regulation the desire to have an open and transparentCommunity procedure for the designation of potential medicinal products as orphan medicinalproducts. Objective criteria have been established and are based on the prevalence of thecondition (5/10.000) for which diagnosis, prevention or treatment is sought.
The orphan drug regulation is the result of an unwritten contract between society (or theGovernments in their capacity as the expression of society’s will) and the pharmaceuticalindustry to undertake R&D programs “without return on investment” in exchange of financialsupports and a period of market exclusivity.
In 1992, the US Food and Drug Administration issued final regulations implementing thedesignation mechanism for the Orphan Drug Act.
However, while the EU legislation recognises that patients suffering from rare conditions should
be entitled to the same quality of treatment as other patients, and therefore has adopted the
Orphan Drug regulation No 141/2000 in order to stimulate the research, development and
bringing to the market of appropriate medications by the pharmaceutical industry, no such
incentive has been given to the Medical Device Industry.
Yet, there are several rare diseases or conditions that can only be treated by or with the
help of (often implantable) medical devices, e.g. Parkinson’s disease not any more
adequately controlled by medications , severe spasticity in Multiple sclerosis patients.
The development of high technology medical devices is very costly and R&D intensive.
The risk of obtaining no return on investment for R&D on devices for rare diseases is
The current exclusion of Medical Devices from the EU Orphan Medicinal Products
legislation means that similar incentives do not exist for such treatments as for those
that are drug-based. Thus, patients whose rare conditions can only be effectively
treated with or with the help of medical devices, are facing an unequal situation.
This leads to the recognition that the existing legislation on Orphan Drugs and
Medical Devices needs to be up-dated in order to stimulate the often very costly and
intensive research and development bringing to the market of new device-based
therapies able to meet the unmet medical needs in the field of rare disorders.
The US Food and Drug Administration has recognised the fact that for diseases and conditionsaffecting small populations, a device manufacturer's R&D costs can exceed its market returns,thereby creating an impediment to the development of such a device. By promulgating itsHumanitarian Use regulations for devices, effective October 1996, the US created an incentivefor the development of devices for use in the treatment or diagnosis or conditions affecting asmall number of individuals.
Examples of Medical Devices used for rare diseases
Definition of rare disease used:Decision No 1295/99/EC of the EU Parliament and of the Council on the Programme ofCommunity Action on Rare Diseases : prevalence of 5 per 10.000
in the Community.
Medical DevicesMedical Devices cover a very wide range of products: aids for disabled, active implantabledevices, anaesthetic/respiratory devices, dental devices, electromedical, hospital equipment,imaging, in vitro diagnostics, ophthalmic and optical devices, passive implantable devices, singleuse devices, surgical instruments.
For the definition of Medical Devices we refer to the European legislation for Medical Devices:Council Directive 90/385/EEC regarding Active Implantable Medical Devices and CouncilDirective 93/42/EEC concerning Medical Devices.
Examples• Deep Brain Stimulation for the treatment of Parkinson’s disease
This therapy involves the use of an active implantable medical device to deliver mildelectrical stimulation to structures deep within the brain for patients with uncontrolledParkinson’s disease. The therapy blocks the abnormal brain signals that are related toParkinson’s disease symptoms. The therapy is reversible and can be used bilaterally. Theparameters for stimulation can be adjusted to increase efficacy and decrease or eliminateside effects.
This therapy is intended in patients who are diagnosed with Parkinson’s disease notadequately controlled by medications and in patients disabled by dyskinesias and motorfluctuations associated with pharmaceutical treatment for Parkinson’s disease. Theneurologists estimate that the number of patients eligible for this therapy is about 4,5/10.000in the EU Community. The incidence is 0,6/10.000.
• Implantable programmable drug delivery pumps
A programmable, implantable drug delivery pump is used for the intrathecal administrationof Baclofen for patients with Multiple Sclerosis with severe spasticity.
Baclofen has a low blood/brain barrier penetration, with high systemic absorption, low CNSabsorption and a lack of preferential spinal cord distribution. Thanks to the intrathecaladministration, the solution of Baclofen is directly delivered into the intrathecal space wherefluid flows around the spinal cord. The drug is directly delivered to where it is needed in thespinal cord, does not circulate throughout the body in the blood and the dose needed isabout 1/100th of the oral dose. This helps minimise the unacceptable systemic side effects,such as muscle weakness, sleepiness, and nausea/vomiting, headaches or dizziness thatoften accompany oral medication at those doses effective for severe spasticity.
The prevalence of MS in the EU Community is about 7/10.000. Of all patients with MS,about 13% develop severe spasticity and can be eligible for the Intrathecal Baclofentreatment. This means a prevalence of about 1/10.000.
Clinical studies are being carried out for the use and adaptation of the implantable drugdelivery pumps for the administration of new orphan drugs for other rare diseases. Thesedrugs are inactive when not administered with the implantable drug delivery pump thatbrings the drug exactly at the site of action.
Fax 0041 21 802 79 15E-mail: firstname.lastname@example.org
CONTENTS Cancer Studies in Humans .3 Cancer Studies in Experimental Animals .4 Studies on Mechanisms of Carcinogenesis.4 Properties. 4 Use . 5 Production . 6 Exposure . 6 OESTRADIOL-17b, OESTRADIOL 3-BENZOATE. 8 Experimental data . 8 Human data. 8 Evaluation. 8 Experimental data . 8 Human data. 9 Evaluation. 9 Experimental data . 9 Human data. 9 Evaluation. 9 Experimental data . 10
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