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The Swedish Childhood Cancer Fund

SCCF

The Swedish Childhood Cancer Fund is a non-profit organisation dedicated to collecting money to prevent and combat cancer diseases in children.

Lobbying Activity

Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

1/. In parallel with the revision of the EU general pharmaceutical legislation there is a revision of the EU legislation on Blood, Tissues and Cells (BTC). These two initiatives need to be harmonized. There are two major concerns with the proposed changes in the BTC legislation which both could have a major negative impact on the future safety and efficacy of advanced medicinal products based on genes, tissues or cells (ATMPs). A. The scope of the BTC revision is unclear. What are “novel BTC products”, do they include also ATMPs? Transfer of ATMPs from the pharmaceutical- to the BTC legislation will lower the standard of safety and efficacy and might results in unsafe medicinal products. • ATMPs are regulated at the European level under the pharmaceutical legislation enabling an easy and transparent oversight and control of authorized products based on common standards. BTCs are regulated at the level of individual member states under the BTC legislation and regulation is therefore less transparent and based on separate standards of safety and efficacy. Since cell/tissue-based products are not well-characterised biologicals, the benefit/risk assessment should be based on clinical trials under the pharmaceutical legislation to protect the patients in the best possible way. • In addition, frivolous companies might take advantage of the situation and establish business in countries with less strict national regulations and offer unproven cell- and tissue-based products to vulnerable patients at very high costs. This is already happening in certain member states for a variety of serious diseases. These treatments can pose serious risks to patients for little or no benefit. B. One intention of the BTC revision seems to be to apply separate legal frameworks for cell-based products produced in a pharmaceutical facility vs. in a hospital, where cell-based products produced in a hospital setting should no longer be defined as ATMPs as they are not industrially manufactured. More relaxed criteria for similar products produced in a hospital vs. in a pharmaceutical facility cannot be justified. • It’s the level of manipulation and non-homologous use that defines if a product is an ATMP, not where the product is made. Also, if ATMPs were to be produced in hospitals, the consequence would be that patients wouldn’t know if the quality of the products differs between hospitals and between member states. • Access to affordable medicines is of utmost importance to patients, and it is possible that prices might be lower and products more accessible if produced in a hospital. But this does not outweigh the need for the products to be efficient, safe and of high quality in all member states, which can only be guaranteed if regulated under the pharmaceutical legislation. 2/. It should be mandatory for Health Technology Assessors (HTA), to provide input to the design of clinical trials to make sure they address both the patient’s needs and the evidence needed by both regulatory authorities and downstream decision makers. • Today, market authorization applicants are not obliged to deliver data such as overall survival, quality of life or patient-reported outcomes that are crucial for informed decision-making by payers, treating physicians and patients. 3/ It is of utmost importance to have EU-wide, professional, reliable, transparent registries with high quality data and high coverage to confirm proof of efficacy and safety. • Health data should not be owned by MAHs. Private-public partnerships should be explored to provide proper funding and foster development of EU-wide, high quality registries. • Development of digital tools needs to be speeded up to facilitate and streamline reporting from reporting centers. • It is very important to allow the transfer of information across borders and the General Data Protection Regulation (GDPR) must not be an impediment to collection and sharing of patient data.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

7 Jul 2020

The Swedish Childhood Cancer Fund is a non-for-profit organization that combat childhood cancer by supporting research and development of new cancer treatments, offering help and support to affected children and their families, and by raising awareness of the many childhood cancer diseases. Our feedback on the Pharmaceutical initiative is attached.
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Response to Europe’s Beating Cancer Plan

2 Mar 2020

The Swedish Childhood Cancer Fund (NGO) welcomes the consultation of the roadmap for Europe’s Beating Cancer Plan with great humility. Being a representative of pediatric cancer, we are with confidence looking forward to a cancer plan where pediatric cancer naturally takes place on the agenda. Prioritized areas are: 1) Drug development: Many new drugs are being developed for cancer, but only few of them are developed for children. We need to find a way to let children get access to new drugs in the same pace as adults. At the same time, we need to prioritize which trials to perform on a European level, since childhood cancer are rare diseases and too many trials reduce the statistical power of the individual trials due to lack of patients. Also, adolescents should be able to participate in clinical trials designed for adults. 2) Medico-legal: We need to make better use of research infrastructures such as tissue biobanks, clinical and data registries, particularly in the field of rare diseases such as pediatric cancer. To do this it is needed to promote a harmonization around medico-legal conditions across borders. 3) Survivors: There are approximately half a million childhood cancer survivors in Europe. These survivors often suffer from late complications and sometimes life-threatening conditions. There is a need to focus on how to prevent late complications caused by cancer treatment today and a need to focus on how to treat the late complications that many cancer survivors suffer from, today. 4) Drugs: There is a need to pay more attention to the dangers of the drug supply - that is, we are currently fully entrusted to the companies/industry to provide us with established drugs for both direct treatment of cancer as well as supportive care. How can we come around this and is there a way to make treatment more independent? 5) Charities: Collaboration between charities/NGOs needs to be promoted and encouraged to avoid fragmentation. We have already started a collaboration on a Nordic level between childhood cancer funds where all countries are eager to participate and work together forward and we clearly see that there is a potential to develop this further to overcome inequities between countries in this matter.
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