The revision of the legislative framework for pharmaceuticals and medicines for children and rare diseases will drop the curtain on next year’s Commission agenda as they are expected to be adopted in December 2022.
The much-awaited initiative to overhaul the current EU’s legislation on medicines is due to be presented at the very end of next year, according to a Commission’s draft working programme seen by EURACTIV.com.
The Commission is due to present its working programme before MEPs during the next European Parliament’s plenary, but it is still to be confirmed, an EU official told EURACTIV.
The EU executive launched a public consultation on revising the general pharmaceutical, legal framework on 28 September, after publishing a roadmap last March that scheduled the final adoption by the fourth quarter of 2022.
Together with the general pharmaceutical legal framework, the Commission will also look more specifically into developing products in areas of high unmet needs for patients and children.
The initiative will streamline the procedures linked to the evaluation and authorisation of medicines for rare diseases and children.
As highlighted in its pharmaceutical strategy presented last November, the Commission wants to reorient a new system of pharmaceutical incentives to stimulate innovation in areas of unmet medical needs, such as neurodegenerative and rare diseases and pediatric cancer.
An example of unmet medical needs mentioned in the document is antimicrobial resistance (AMR), which decreases doctors’ ability to treat infectious diseases and perform routine surgery.
According to the draft working programme, another key point of the 2022 policy agenda will be the proposal to update recommendations to member states on cancer screening, which is currently limited to breast, colorectal, and cervical cancer.
This initiative ensures that screening programmes for early detection will also reflect the latest available scientific evidence, including prostate, lung and gastric cancer, to the guidelines recommended to the member states.
The work on this update will be informed by the European Commission’s group’s scientific advisories prepared by early 2022, while the proposal’s publication is expected by the third quarter of 2022.
By the beginning of November 2022, the Commission is also expected to amend the existing binding occupational exposure limit value for cancer-causing asbestos.
Asbestos is a group of six naturally occurring minerals made up of thin, microscopic fibres. Thanks to their heat and chemical resistance, asbestos was commonly used as a building material. It can be found in many products, including roofing shingles and water supply lines.
But asbestos exposure can lead to many severe health problems, including cancer of the lung, larynx, ovaries, and mesothelioma.
Last July, the European Parliament voted in favour of a resolution calling for the creation of a strategy to eliminate asbestos in a bid to strengthen workers’ protection and reduce exposure to this common chemical.
In the context of the zero pollution package due to be unveiled in May 2022, the Commission will also launch a new classification, labelling and packaging (CLP) that will include hazard classes for a number of hazardous properties in a bid further to raise the level of protection of human health.
Among the new hazard classes, there should be one dedicated to endocrine disruptors, which are commonly found throughout our environment in children’s products, food containers, personal care products, pesticides and furniture.
These hazardous substances alter the functioning of the hormonal system, harming the health of humans and animals.
Close to 800 chemicals are known or suspected to interfere with hormone receptors, hormone synthesis or hormone conversion, according to a report drafted in 2012 by the United Nations Environment Programme (UNEP) and the World Health Organisation (WHO).