TBCT Statement on the Proposed Revision of the Pharmaceutical Package 

Transforming Breast Cancer Together (TBCT) – a multi-stakeholder group representing patient and healthcare professional organisations, experts and industry – welcomes the objectives set by the European Commission for the EU pharmaceutical package, based on the four pillars of the Pharmaceutical Strategy for Europe adopted in November 2020:  

  1. ensuring access to affordable medicines 
  1. supporting competitiveness, innovation and sustainability 
  1. enhancing crisis preparedness and response mechanism 
  1. ensuring a strong EU voice in the world 

At TBCT, we believe that it is imperative to ensure that people affected by breast cancer have access to safe, innovative and high-quality procedures throughout the care pathway, from early diagnosis through treatment, including after-care and end-of-life care. The system must remain patient-centred and be informed through real-life experiences coming from patients, patient-advocacy organisations and the various support teams that are dedicated to providing quality care for individuals and their loved ones. 

In view of the proposed pharmaceutical package, TBCT urges the Council of the EU and the European Parliament to consider the following priorities to: 

  • Ensure timely and equal access to medicines for people living with cancer and continued innovation in oncology 
  • Recognise the existing unmet medical needs (UMN) in the area of breast cancer. Breast cancer is the most common diagnosis in the cancer spectrum, impacting 1 in 7 women, and a patient-centred broad definition of UMN is needed to incentivise avenues of research and meet the needs of people living with (early and metastatic) breast cancer  
  • Establish adequate access pathways in all Member States, by favouring patient-centred therapies (such as oral cancer medicines, as an example amongst others), and tackling and mitigating shortages, especially for critical cancer medicines across the EU  
  • Foster a thriving medical innovation eco-system to create a favourable environment for research and ensure European patients have access to new and more personalised treatments. The Mission on Cancer and the EU Innovation Agenda should be leveraged to support this key pre-requisite supporting incremental innovation in oncology diagnostic and treatment to respond to the still existing unmet medical needs for people living with breast cancer and in different geographies 
  • Improve the efficiency of the European Medicines Agency’s marketing authorisation process, e.g., through streamlined, accelerated pathways for new technologies with the suggested measures for greater involvement of patient representatives in the consultation process. Regulatory pathways should reflect the evolution of innovation and technologies, including precision oncology (e.g., tumour-agnostic therapy). For instance, the regulatory sandbox proposal can be an effective tool to help innovators test new therapies at early stages of development in a safe and controlled environment where real world evidence is generated 
  • Promote research and deploy new technologies to improve screening, the quality of diagnosis and care; facilitate personalised cancer medicine by providing a balanced and predictable system of Intellectual Property and a regulatory framework with adequate timelines and conditions allowing to provide evidence on the attainment of unmet medical need and to drive innovation 

Share Post: