Deletion of the term "radionuclide" before the term "kit"
AIPES has been successful in lobbying the European Parliament and the Council of Ministers within the framework of the adoption of the EC pharmaceutical package.
The original Article 1.8 Directive 2001/83 on medicinal products, which was being revised by the European Parliament at first reading in 2002, read as follows.
'Radionuclide kit': any preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration.
Although AIPES agreed with the above definition of 'kit', its representatives demonstrated to the EU officials that a "kit" is never radioactive as such and that, accordingly, the term "kit" should not be preceded by the term "Radionuclide". Indeed, a kit cannot itself be considered as radioactive. A kit is in fact a non-radioactive radiopharmaceutical which contains an active ingredient. Kits do not therefore contain any radioactive material when they are put on the market. Moreover, a kit has still to be labelled before administration, in accordance with rules which differ from those applying to radioactive medicinal products. It is only when the kit is reconstituted or combined with a radioisotope by authorised persons in hospitals that it gives rise to a radioactive medicinal product which is then injected into/administered to a patient.
All this explains why a kit is not submitted to the rules which govern the production, sale, transport and labelling of radioactive materials.
If the wording "radionuclide" kit was maintained, this could have created confusion with radioactive radiopharmaceuticals. This could then have led Member States to submit kits to the same restrictions which apply to such radioactive radiopharmaceuticals at the stage of manufacturing, storage, transport or use of radioactive radiopharmaceuticals.
AIPES was thus successful in convincing the European Parliament and then the Council of Ministers to delete the term "radionuclide" before the word "kit".
As a result, Article 1.8 of Directive 2001/83 as modified by Directive 2004/27, now reads as follows:
'Kit': any preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration ((include as a link in the AIPES website the text of Directive 2004/27)
Radiopharmaceuticals are exempted from being labelled in Braille
Article 56 of Directive 2001/83, as modified by Article 1)42 of Directive 2004/27, requires the name of the medicinal products to be expressed in Braille on the packaging.
This article needed to be interpreted in a subsequent Guidance, to be adopted by the European Member States and the European Commission.
Within this perspective, AIPES representatives explained to the EU officials that contrary to the majority of other medicinal products, radiopharmaceuticals are never sold to people in pharmacies, neither are they available as prescription products for self administration. They are delivered directly to hospitals, upon doctors' requests, and administered to patients under professional supervision, or to specialized nuclear medicine centres, where they are manipulated by medically trained personnel.
Moreover, due to their specific nature (by definition, radiopharmaceuticals contain radioactive substances), radiopharmaceuticals are submitted to very strict rules concerning their manufacture, packaging, labeling, transport, manipulation and use. Hence, radiopharmaceutical products are never remitted into the hands of patients. Summaries of Product Characteristics (SPCs) and user leaflets of radiopharmaceutical products always indicate that radiopharmaceuticals should only be received, used and administered by authorised persons in designed clinical settings and that receipt, storage, use, transfer and disposal are subjected to the regulations and appropriate licences of the competent authorities.
Likewise, diagnostic medicinal products which are intended for use in a hospital are never remitted into the hands of patients. They are supplied directly to hospitals where they are administered to the patient by professional personnel. Therefore, blind or partially sighted people are never be required to handle the packaging of these products.
By obliging radiopharmaceuticals and hospital use diagnostic medicinal products to include Braille on their packaging, the EU legislation would have imposed a totally useless burden on industry without creating any advantage to the benefit of patients.
As a consequence of this lobbying action undertaken by AIPES (among other actions undertaken by other sectors of the medicinal industry), the final EU Guidance concerning the Braille requirements for labelling and the package leaflet ((include as a link in the AIPES website the text of the Guidance) states that :
"There is no need to put the name in Braille on the packaging of products which are only intended for administration by health care professionals, for example it is not required to put the name in Braille for vaccines".