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Institut National du Cancer

INC

The goals of the INC are: - coordinate and reinforce all actions in the fight against cancer, - to facilitate access for people with cancer, wherever they are treated in the country, whatever the stage of their disease and the complexity of their treatment, to a structured, standardised, high-quality clinical and care pathway, incorporating the latest scientific data and international best practice, in complete safety, - to develop and monitor joint initiatives with public and private cancer operators in the fields of prevention, screening, care, research, teaching, epidemiology and surveillance, - contribute to controlling healthcare expenditure in the field of oncology.

Lobbying Activity

Response to Evaluation and revision of the general pharmaceutical legislation

6 Nov 2023

The INC has the pleasure of submitting its feedback prepared in consultation with the interinstitutional WG on oncopediatrics of the 2nd National Cancer Plan of Luxembourg. -Science-based paediatric drug development: We value the introduction of paediatric medicine development based on the molecular target. This acknowledges that children deserve access to treatments designed with their specific needs in mind. It rectifies an existing regulatory framework gap, as there is no obligation to submit a PIP if the medicine was initially developed for adult cancer and has no existing paediatric counterpart. This gap often results in limited development of paediatric indications for medicines that could benefit children. -Improved access to novel anticancer drugs: We support introducing a dedicated extension of data protection for new drugs. This is an important progress towards greater equality for children with cancer across EU. -Improved access to essential anticancer drugs: We support the proposal focused on improving access to essential anticancer medicines. Introducing a dedicated chapter addressing medicine shortages and establishing an EU-wide list of critical medicines is crucial to ensuring that patients, particularly those battling cancer, have consistent access to their treatments. While these aspects of the proposal align with our expectations, we maintain that specific areas demand additional clarifications/modification to strengthen the reform and more effectively address the unmet medical requirements of children battling cancer: -Creation of a European network: While we support the creation of a European network as a means to foster multistakeholder involvement, provisions for ensuring adequate funding for the essential contribution of academic experts and patient representatives are encouraged. Moreover, the objectives of this network, among others, the prioritisation of clinical development of medicines for children should be strengthened by allocating specific EU funding. -Drugs repurposing: We endorse the idea of streamlining the repurposing of drugs, particularly in treating paediatric illnesses. We support the notion of non-profit organisations playing a pivotal role in generating data for repurposed drugs. However, the successful implementation of this strategy demands sufficient resources for academic-led research and an adequate capacity within the EMA to grant access to life-saving medications for patients who may otherwise have to rely on off-label prescriptions. A mechanism to guarantee that the pharma industry continues collaborating with academia by providing new drugs and funding for research trials is crucial. However, it is important that academic evaluations adhere to the same standards/best practices as clinical research, and that the EMAs process be adjusted for such new pathways. -Early start for paediatric drug development: We approve implementing the evolutionary PIP approach. However, we suggest strengthening the explicit requirement to submit PIPs upon the conclusion of phase I clinical studies in adults rather than before commencing phase II clinical studies in adults. The introduction of penalties to discourage companies from delaying PIP submissions should be considered. -Investment in paediatric drug development: The proposal lacks dedicated incentives for the initial development and marketing authorisation of drugs for paediatric use. We strongly urge the inclusion of an incentive for first-in-child marketing authorisation. This measure is anticipated to increase commercial interest in developing medicines targeting paediatric cancers and rare paediatric diseases. That said, a balance should be found that, on one side, acknowledges the need for developing such medicines and, on the other side, does not set a precedent to inappropriately favour specific patient populations/diseases. The impact of such incentives on pricing strategies should be evaluated to avoid pricing coercion.
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