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Invitation
Meeting of the European Parliament Interest Groups
MEPs Against Cancer and MEPs for CAM
Complementary and Alternative Medicine
(CAM): An investment in health
Date: Thursday 27 June 2013, 09:00-11:00
Venue: European Parliament, Room JAN 6Q1
Keynote speech and conclusion by DG SANCO Commissioner Tonio Borg
CAM is a cost-effective, sustainable means to promote health, prevent and treat
disease. Especially now that Europe faces a growing number of challenges in the
area of healthcare such as an ageing population, antimicrobial resistance,
chronic diseases, maintaining the health workforce, growing levels of mental illhealth,
rising healthcare budgets etc, it is time CAM is given serious
consideration as both innovation and added value for healthcare in Europe.
Many citizens in Europe value the practice of CAM and wish to have equitable
access to CAM provision. Enabling this provision requires transparent common
regulation of CAM practice and training and CAM medicines across the EU.
Speakers from the CAM community and academia have been invited to make
presentations outlining the role of CAM in prevention and treatment, its costeffectiveness
and efficiency, its provision, its integration into the healthcare
system and its suitability for the EU’s current “Investing in Health” policy.
The meeting will offer the opportunity for policy makers and stakeholders to enter
into an active dialogue on a subject that is highly relevant for the health of all EU
citizens. The attendance and input of DG SANCO Commissioner Borg will make
this meeting a unique event.
Thank you for your support, we look forward to welcoming you on 27 June.
Hosted by Alojz Peterle MEP and Sirpa Pietikäinen MEP

PTO FOR

 

MEPs Against Cancer Round Table

PHOTOS HERE    

Summary Report Below

Fits and Mis-fits:  Advanced Therapy for Medicinal Products (ATMP) Legislation
 
15th October 2013
9:30am to 12pm, European Parliament, Brussels, ASP 5F385
Hosted by MEP Alojz Peterle
 
 

At the core of the discussion lies the idea proposed by several leading European oncologists that the existing Advanced Therapy Medicinal Products Directive (ATMP) is not equipping oncologists involved in vaccine based targeted treatments for certain patients with the correct legislative framework.

Professor Stefaan Van Gool from Gasthuisberg Hospital, Leuven, a world-renown specialist in paediatric oncology provided a proposal for a new European legislation that would complement the existing ATMP directive (not replace) that will enable a more patient-centred treatment approach within European legislation. 

Programme

Background document: The origins and outline of the Advanced Therapy Treatment concept

Prior to this event, there was a MEPs Against Cancer visit organised to the Immunotherapy Platform in Leuven on May 13

 

Summary Report 

 

 

MAC 

Alojz Peterle MEP and MAC President, Professor Van Gool of KU Leuven, Ilse de Reze of the

Olivia Hendrix Foundation and Professor Phillipe Lewalle Clinical Director of the Jules Bordet Institute.

 

Fits and Mis-fits: Advanced Therapy for Medicinal Products (ATMP) Legislation

 

On the 15th October, 2013, the MEPs Against Cancer group facilitated a meeting on the challenges of working on immunotherapy treatments under the Advanced Therapy for Medicinal Products Legislation.  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).

Rocio Salvador Roldan, DG Health and Consumers, Unit D5 – Medicinal products – authorisations made a presentation on the strengths and weaknesses of the current legislation which is currently undergoing a consultation process. Three types of ATMPs are covered by the legislation:

  • gene therapy medicinal products
  • somatic-cell therapy medicinal products
  • tissue engineering medicinal products

The legislation also provides for marketing licences for products developed by immunotherapy and a framework for achieving ATMP status for advanced therapy treatments.

Professor Matthias Eyrich of the Wurzburg Children’s Hospital in Germany described problems he has experienced firsthand with working under the remit of ATMP. In Germany, in the field of immunotherapy, there is a huge discrepancy between patient’s needs for innovative treatments and what medics can offer them. As a result, they have been sending on average 30 patients per year to Leuven University Hospital to be treated by Professor Van Gool. The use of ATMP in Germany can be applied under clinical trials and through use of a legal article (known as paragraph 4b) which allows for them to be carried out if production and treatment is in the hands of one physician, a production license is be issued and if individual benefit is be visible. However data from this treatment is not allowed to be used for scientific analysis. In Germany, hospital exemption is only permitted on the authority of the federal level decision and is therefore very difficult to obtain.

According to Professor Eyrich the shortcomings to the ATMP regulation include the current rules for  early phase developments that do not allow a timely translation in this field making Europe is uncompetitive in this area. In more advanced phases (I/II, optimization) current rules also do not allow academic hospitals to react flexibly and meet patients needs for innovative treatments: the timeline from the bench to bedside too long. He also stated that Hospital Exemption (HE) is too imprecise and highly diverse interpreted across EU, it also precludes data analysis, the genuine interest of academic centres. ATMP means that patients can be treated for orphan diseases but the legislation makes data analysis very difficult.

Professor Eyrich made the following comments and recommendations for the improvements to the ATMP regulation:

  • Use of immunotherapeutic ATMPs in cancer treatment must be embedded  into multimodal approaches, which require specialized centres and  interdisciplinary teams
  • The biggest handicap is not ATMP production, but legal framework  for application
  • Extension of HE to open ATMPs to be used in TOS would:
    • prevent misuse in unsupervised treatments
    • facilitate patient access to controlled trials, thereby preventing medical tourism
    • enable reimbursement by health insurances
    • allow full pharmacovigilance by competent authorities
    • For orphan diseases inclusion of treatment data into registries should be encouraged

Patient advocate Piet Jurgwal and the father of a survivor treated by Professor Van Gool both gave testimonies to the quality of and efficacy of Professor Van Gool’s treatments. Mr Jurgwal underwent successful treatment with Professor Van Gool after being diagnosed with a stage four brain tumour which his physicians in the Netherlands had been unable to treat. Mr Jonak’s son was treated by Professor Van Gool for his brain tumour and is now working in Germany, drives a car and with his father has set up a patient support group in their area. One of the aims of their group is to encourage the spread of Professor Van Gool’s treatments to prevent unnecessary deaths among people unable to access the same quality of treatment.

 

Piet 

Piet (Brain Cancer Survivor) and Jannigje Burgwal

 Professor Van Gool outlined his proposal for a new legal framework for Advanced Therapy Treatments (ATT) would be different from ATMP in several ways summarised in the box below.

ATT and ATMP: aiming for complementary legislation

 

  • ATT is a treatment, ATMP are medical products.
  • 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 medica lcentre. 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.
  • ATT needs a patient-oriented quality control system instead of process-oriented quality control.
  • 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.
  • 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.
  • 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.
  • 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.
.

Prof. Dr. Mark Waer, Honorary Rector of KU Leuven opened his session by expressing support for the ATT proposal as he believed it would speed up approval processes and close the gap between the lab and the patient. He also sees a need for harmonisation of legal initiatives in the EU and opened the question of adapting the hospital exemption clause in ATMP to solve some of these problems. He also referred to the need to enable centres to exchange data from ATMPs across borders in order to maximise the results of treatments

Patricia Blanc, the Executive Director of Imagine for Margot, an NGO set up in the memory of her daughter who died of brain cancer started the expert panel with a call for more clinical trials for children in Europe. The current legislative framework creates too much paperwork which takes up time better spent on treatments. She added that the regulation on clinical trials has currently progressed, and feels strongly that the ATMP should do the same. 

Professor Paolo Casali iterated that the key issues in cancer today are personalised oncology, multidiciplinary care and rare cancers. Within these areas four points are of vital importance:

a)  Research methodologies and their regulatory implications. There is a need for randomised trials for rare cancers and regulatory bodies to be sensitive to new technologies.

b) With regards the compassionate use and off-label use of drugs, large discrepancies exist across Europe depending on the national legislation. Many children are treated with off-label drugs.

c)  The relationship between academia and the industry arises along with the question ‘what if company is not interested?’ This poses the problem of orphan drugs and hinders the possibilities to develop new drugs.

d) Networking within the remit of the new cross-border healthcare directive will bring some opportunities but it is not yet clear whose rules the networks will come under or who will fund them. Problems of subsidiarity may also arise. 

Arnd Hoeveler (DG Research) iterated that advanced therapies are not limited to cancer but all kinds of diseases. The Commission is supporting new innovative and regenerative medicine by mixing different approaches. ATMP is still an early regulation; with room for improvement while science is quickly evolving. There is a strong focus on offering incentives for SMEs and he recognised that maybe the academia and charity organisations do need more support however we need to avoid medical tourism and pay particular attention to safety aspects.  He also suggested that the ATT proposal should consider whether EU legislation is actually needed in this area and whether the issues should be dealt with by the member states.

Professor Lewalle of the Jules Bordet Institute agreed with the proposal of Professor Van Gool, but also reminded participants that if regulation is too heavy it could risk killing academic research. He added that pharmaceutical companies cannot be relied on to develop treatments for rare cancers therefore regulations should be made to allow the academic world to be partners in immunotherapy. Custom made rules need flexibility and less regulation. If the bar is set too high, people will leave or give up. If it is set too low, it will be ineffective. Europe needs to advance in this area in a collaborative fashion to allow for an innovative and competitive environment that is best for the patient.

 

 

Mac2

Alojz Peterle MEP, Prof. Dr. Mark Waer (Honorary Rector of KU Leuven), Ilse de Reze (Olivia Hendrickx Research Fund), Johnathan Stabenow (Assistant to Ivo Belet MEP), Emma Woodford (ECL), Professor Nadine Ectors (KU Leuven), Professor Paolo Casali (Milan Cancer Insititute) and Professor Stefaan Van Gool (KU Leuven) discuss follow up to the MAC Round Table on ATMP with members of the European Commission.

 

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