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MEPs Against Cancer Visit to the Immunotherapy Platform Leuven

 

 

The Challenges of Operating under the Advance Therapy Medicinal Products Directive

 

 

 

At the request of the President of the MEPs Against Cancer, on the 13th May 2013, ECL accompanied Aljoz Peterle MEP, Johnathan Stabenow, assistant to Ivo Belet MEP, a member of the Directorate General for Internal Policies in the European Parliament and colleagues from SIOPE and ECCO on a visit to the Immunotherapy Platform of Gasthuisberg Hospital in Leuven, Belgium.

Professor Koen Debackere introduced the translational research team at Gasthuisberg Hospital and identified fragmentation in research funding and inappropriate legislative frameworks asthemain barriers to the sustainable development of their work. For example, in order to implement the innovative immunotherapy on paediatric patients with brain tumours, the research group in Leuven traditionally relys on three pillars of support:

  • Agency for Innovation by Science and Technology in Flanders (Applied biomedical research with societal purpose)
  • National Fund for scientific research,
  • Negotiation with the Belgian state for reimbursement of end-stage clinical research within academia on innovative treatments with a certain evidence level of efficacy.

In addition, The Olivia Hendrickx Research Fund sponsorship has also been crucial in promoting entrepreneurship, influencing the Belgian regulatory framework and motivatingfuture research activities of the department.

 

IMG_1372

 

Professor Dr Stefaan Van Gool, Purificacion Tejedor Del Real Directorate General for Internal Policies, and Aljoz Peterle President of the MEPs Against Cancer touring the research facilities of Gasthuisberg Hospital.

 

 

 

 

 

Professor Dr. Stefaan Van Gool provided a presentation on the mechanisms of immunotherapy for patients and explained the principles of tumour vaccination. Preliminary evidence from clinical trials werepresented which showed that patients have benefited better overall survival. Patients from 26 countries have visited the medical centre for treatment. The handling of cells and tissues taken from patients requiresadherence to Good Tissue Practice (GTP). The subsequent manipulation of the cells and manufacture of vaccines is within the regulation of Advanced-Therapy Medicinal Products (ATMP) as part of the Good Manufacturing Practice (GMP). Finally, implementation of clinical trials of vaccinations is regulated by Good Clinical Practice (GCP).

 

Currently however there is no unified framework to regulate the kinds of advanced therapy treatments that are taking place in the laboratories of Gasthuisberg Leuven. Prof. Van Gool introduced this problem to the visitors as an area in which his team need assistance to persuade legislators in the EU to create a European framework which would allow academic hospitals in Europe to develop similar practices without the need, for example, of marketing licensing and hospital exemptions. Professor Van Gool stated that it was a clear case where research techniques and treatment have moved faster than current legislation. Professor Ectors, the KU Leuven Tissue Bank Director, also called for the urgent need to adapt existing regulations since the current Advanced Therapy Medicinal Products Directive 2004/23/EC does not accurately cover clinical and research activities in immunotherapy. A new specific and relevant European legislation is seen as essential.

 

 Vaccin  Participants

Staff of Gasthuisberg Leuven Hospital preparing the vaccine and ECL staff, Mr Peterle and Luc van Haute, CEO of The Belgian Foundation Against Cancer

 

Prof. Van Gool iterated that research requires collaboration between four types of actors: teaching hospitals, families and patients, companies and communities. In the consideration of the common European regulatory framework, all the legal and financial aspects also have to be taken into detailed consideration. Prof Van Gool concluded that there is currently no unified framework in regulating immuno-therapy as a single domain. In addition to putting both researchers and clinicians at risks, this also makes forging collaboration on a European level extremely difficult.

At the core of the discussion lies the idea by Professor Van Gool, which is supported by immunotherapy oncologists across Europe, to propose a new European legislation that would complement the existing ATMP directive (not replace). The proposed legal framework for Advanced Therapy Treatments (ATT) would be different from ATMP in several ways:

  1. ATT is a treatment, ATMP are medical products.
  2. ATT is aimed as treatment for patients with specified niche indications: patients with low incidence clinical situations who need a multidisciplinary complex and also very often multimodal treatment in a highly specialized medical centre. This means that full standardisation of their treatment needs some flexibility due to patient individuality in the context of their illness which is not possible under ATMP.
  3. ATT needs a patient-oriented quality control system instead of process-oriented quality control.
  4. ATT is performed according to specific quality standards, and provided within the Member State in a hospital under the exclusive professional responsibility of a medical practitioner in order to comply with an individual medical prescription for a custom-made advanced therapy realized within the hospital as treatment for an individual patient.
  5. ATT needs a system of licensing for treatment in medical hospitals instead of marketing authorization for a production facility. Control of cost is mandatory in the balance between efficacy, quality, safety, and reality (small number, small productions, and personalized treatment of seriously diseased non-standardized patients). Specific rules are needed that are different from the requirements of the pharmaceutical industry.
  6. The concept of ATT requires a framework at the European level that defines the scope within which each Member State can facilitate the development and implementation of ATT.
  7. The legislation should also facilitate the creation of international networks, possibly in some form of relation to the cross-border health care directive, in which experience is shared within university hospitals over the country borders, and by which ATT become accessible to patients in each country.

To follow up from this visit an MEPs Against Cancer round table for invited stakeholders is planned in the on October 15th 2013 in the European Parliament. The aim of the meeting is to present more examples of advanced therapy treatments beyond the laboratories of Professor van Gool and bring together representatives from DG Research and DG SANCO to discuss the best way forward to improve conditions for cancer patients and hospital based practitioners using similar form of advanced therapy treatments in the European Union.

 

Annex One: Diagrammatic differences between ATMP and ATT

ATMP

 

ATT

 

Annex Two: Immunotherapy oncologists currently supporting the ATT proposal:

 

Title

Name

Institute/hospital

MD, PhD

Birgit Burdhardt

PediatricsHermatology and Oncology, University Hospital Münster

Professor

Angus Dalgleish

St George's University of London

Professor, MD

Stefan Ehl

Centre of Chronic Immunodeficiency, Freiburg, Germany

Professor, MD

Hermann Eichler

Institute of Clinical Haematology and Transfusion Medicine, Saarland University Hospital, Hamburg

Professor, MD

M. Eyrich

Universitats-Kinderklinik Wurzburg

Professor, MD

Norbert Graf

Saarland University, Dep. Paediatric Oncology and Haematology, Campus Homburg, 66421 Homburg

MD

Rupert Handgretinger

Department of Hematology/Oncology, Children's University Hospital, Tübingen, Germany

Professor, MD

Jan-Inge Henter

KarolinskaInstitutet, Karolinska University Hospital, Stockholm

Professor, MD

Gunnar Kvalheim

Department of Cellular Therapy, Radiumhospitalet, Oslo University Hospital

MD

Emanuil Naydenov

Bulgarian Society of Neurooncology

MD

Tim Niehues

Helios Klinikum Krefeld

Professor, MD

Charlotte Niemeyer

Universitatsklinikum Freiburg

MD, PhD

Claudia Rossig

University Children's Hospital Münster

Professor, MD

Paul G. Schlegel

Children's University HospoitalWuzerzburg, Pediatric Hematology, Oncology, Stem cell Transplant.

MD, PhD

Rüdiger V. Sorg

Institute for Transplantation Diagnostics and Cell Therapies, Heinrich Heine University Hospital

PhD, PD, MER

Paul R Walker

Geneva University Hospitals and University of Geneva

 

 

 

 

Two patient representatives also recounted their experiences with the treatment in Leuven. Patient A was from the Netherlands and was diagnosed of a right brain tumour. After initial successes of treatment there, the cancer relapsed in March 2012 and he was told that his tumour was no longer feasible for further surgery. Through consultations with his doctor, patient A decided to come to Leuven to try this particular immunotherapy treatment. The treatment was effective and he considers his quality of life is good at the moment; his is able to work and feels perfectly normal. When this patient recently went for his 12 month check up in his home town hospital in Utrecht, the hospital staff were astounded that his tumour had regressed so much and are now investigating how to start providing Prof van Gool’s innovative treatment in their hospital. Patient A also mentioned that it is crucial to feel comfortable along the course of treatments, to receive support from different people and to get what you expect from the therapy, all of which he received in Gasthuisberg Hospital.

 

The father of patient B, from Germany, gave a testimony for his son who was 17 at the time of the first diagnosis. Patient B went through standard cancer care (including surgery, chemotherapy, radiotherapy and later on also implants), but unfortunately, the patient experienced two relapses (after 5 months and 12 months of treatment). His father described the difficulties that patients and their families experience in getting proper information on cancer care, especially on non-standard cancer care. A paediatric doctor subsequently recommended this biological treatment to the patient and the young man went through surgery and vaccinations in Leuven. There has been no relapse so far. Another issue raised by patient B’s father were the initial difficulties in obtaining reimbursements from the insurance company in Germany, but this matter was later resolved. As a parent of a sick young adult, the father would like to see a common European fund for medical treatments. This also has implications on ethical review boards in different countries for clinical trials to go through. The father emphasised that this is needed as a common European community.

 

  
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