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THE NEW EU CLINICAL
TRIALS REGULATION
Vitafoods Europe
12 May 2016 11:45 – 12:05
Sofie van der Meulen
www.axonlawyers.com
OVERVIEW
• Background and rationale
• Borderline food and medicinal products
• Main changes legal framework for clinical t...
Background Regulation 536/2014
• 17 July 2012: Proposal for a Regulation on clinical trials.
• Regulation: to ensure that ...
Scope Clinical Trials Regulation
Article 1 CTR:
‘This Regulation applies to all clinical trials conducted in the Union.
It...
CTR & food products
5
Legal definition of nutraceutical =
Stephen L. DeFelice, Founder of the
Foundation for Innovation in Medicine,
introduced ...
Therefore… nutraceuticals…
‘blur the line between food and drugs and it is often difficult — by legal
definition — to dist...
Case law ECJ – Van Bennekom
Are vitamin preparations medicinal products?
National authorities should properly assess:
• Th...
ECJ: Garlic case (C-319/05)
What? Garlic pills marketed as food supplements that were
presented in a capsule form.
Are Gar...
ECJ: Delattre case (C-369/88)
What? Products that were sold in Belgium as food supplements
and cosmetics, but qualified as...
What about Coca Cola?
Read more on our blog
www.foodhealthlegal.com
11
EU Clinical Trials Portal and Database
Article 80 – 82 CTR:
“The Agency shall, in collaboration with the Member States and...
EU Clinical Trials Portal and Database
Publicly accessible unless confidentiality is justified on the
following grounds:
•...
Application Part I & Part II
(Art. 6 + 7 CTR)
14
• Therapeutic & public
health benefit aspects
• Risks & inconveniences
fo...
Sponsor & Investigator
15
Co-sponsorship is possible under Article 72 CTR.
- Either in form of equal responsibility for al...
Safety reporting (Art. 41 & 42 CTR)
16
- Investigator: report adverse events/lab abnormalities to sponsor. The
protocol ma...
Informed consent
(Art. 28 – 30 CTR)
17
Detailed description of information and inclusion of
- Patients in general
- Incapa...
Transitory period of 3 years
Until the CTR will become applicable, all clinical trials performed in
the European Union are...
Guidelines
The Commission is working on guidance documents in order to
ensure a uniform application of the legislation on ...
Overview main changes under CTR
• Streamlined application procedure
• Single set of documents for application (Annex I)
• ...
Sofie van der Meulen
Axon Advocaten
Piet Heinkade 183
1019 HC Amsterdam
+31 88 650 6500
+31 6 53 44 05 67
sofie.vandermeul...
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Vitafoods eu clinical trials regulation

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Vitafoods eu clinical trials regulation

  1. 1. THE NEW EU CLINICAL TRIALS REGULATION Vitafoods Europe 12 May 2016 11:45 – 12:05 Sofie van der Meulen www.axonlawyers.com
  2. 2. OVERVIEW • Background and rationale • Borderline food and medicinal products • Main changes legal framework for clinical trials under new Regulation 2
  3. 3. Background Regulation 536/2014 • 17 July 2012: Proposal for a Regulation on clinical trials. • Regulation: to ensure that Member States base their assessment of an application for authorisation on identical criteria throughout the EU. • Aims to create an environment that is favourable for conducting clinical trials in the EU with the highest standards for patient safety. • 16 April 2014: adoption of Regulation • 28 May 2016: applicable from this date! 3
  4. 4. Scope Clinical Trials Regulation Article 1 CTR: ‘This Regulation applies to all clinical trials conducted in the Union. It does not apply to non-interventional studies.’ The Clinical Trials Regulation applies to investigations in relation to humans intended to: • Discover or verify effects of one or more medicinal products; • Identify any adverse reactions to one or more medicinal product; • To study absorption, distribution, metabolism and excretion of one or more medicinal products to ascertain the safety or efficacy. The CTR applies to medicinal products. Not to nutraceuticals… right? 4
  5. 5. CTR & food products 5
  6. 6. Legal definition of nutraceutical = Stephen L. DeFelice, Founder of the Foundation for Innovation in Medicine, introduced ‘nutraceutical’ in 1989 as a portmanteau of the words ‘nutrition’ and ‘pharmaceutical’. 6
  7. 7. Therefore… nutraceuticals… ‘blur the line between food and drugs and it is often difficult — by legal definition — to distinguish between nutrients, food additives, drugs and nutraceuticals.’ Source: Neutraceutical Business Review, www.neutraceuticalbusinessreview.com 7
  8. 8. Case law ECJ – Van Bennekom Are vitamin preparations medicinal products? National authorities should properly assess: • The function of the product and • the presentation of the product. In the Van Bennekom case (C-227/82) the ECJ ruled that the form given to the product (pills, capsules) can serve as strong evidence of the intention of the manufacturer to market a medicinal product, but is not conclusive in its own right. The concept of presentation with respect to borderline products must be broadly conceived. 8
  9. 9. ECJ: Garlic case (C-319/05) What? Garlic pills marketed as food supplements that were presented in a capsule form. Are Garlic pills medicinal products? German authorities: yes. EU Court: No. • The capsule form is not exclusive to medicinal products. • The supplements did not contain any mention that they aimed to prevent or treat a certain disease. • Effect of active ingredient allicin was recognized, but did not transcend the normal metabolism of garlic. Conclusion: the garlic pills were not considered to be medicinal products, neither by presentation, nor by function. 9
  10. 10. ECJ: Delattre case (C-369/88) What? Products that were sold in Belgium as food supplements and cosmetics, but qualified as medicinal products in France. Conclusion EU Court: the products were presented as having positive effects on certain body functions, like the functioning of the gastro intestinal tract or liver and therefore qualified as a medicinal product. Member States may differ on the qualification of borderline products! The national authorities and courts will have to judge on a case-by-case basis if a product is either a food or a medicinal product. If a product can be qualified as food and/or cosmetic and as a medicinal product, the product is considered a medicinal product. 10
  11. 11. What about Coca Cola? Read more on our blog www.foodhealthlegal.com 11
  12. 12. EU Clinical Trials Portal and Database Article 80 – 82 CTR: “The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a portal at Union level as a single entry point for the submission data and information relating to clinical trials in accordance with this Regulation”. Why? • To enable cooperation between the competent authorities of the Member States concerned. • To facilitate communication between sponsors and Member States (reference to previous submissions). • To enable citizens to have access to clinical information about medicinal products. “The EU database shall contain the data and information submitted in accordance with this Regulation” 12
  13. 13. EU Clinical Trials Portal and Database Publicly accessible unless confidentiality is justified on the following grounds: • Protecting personal data in accordance with Regulation 45/2001 • Protecting commercially confidential information • Protecting confidential communication between Member States in relation to preparation of assessment report • Ensuring effective supervision of the conduct of a clinical trial by Member States Sponsor has to submit a summary of results and a lay person summary to the Database one 1 year after the end of the trial in the EU. 13
  14. 14. Application Part I & Part II (Art. 6 + 7 CTR) 14 • Therapeutic & public health benefit aspects • Risks & inconveniences for the subject • Manufacturing/importati on of IMPs/AMPs • Labelling • Investigator’s brochure • Informed consent • Compensation/ rewarding arrangements • Recruitment arrangements • Data protection rules • Suitability of - individuals - trial sites • Damage compensation • Biological samples Part II – NationalPart I – General One Dossier EU Portal
  15. 15. Sponsor & Investigator 15 Co-sponsorship is possible under Article 72 CTR. - Either in form of equal responsibility for all sponsors or - Contract amongst sponsors which defines responsibilities The Principal Investigator has to ensure compliance of a clinical trial at a clinical trial site with the requirements of the CTR (Article 73 CTR). Article 74 (1) CTR: Sponsor has to ensure the establishment of a natural or legal person in the Union as its legal representative. Article 74 (2) CTR: Member States may choose to accept the establishment of a contact point instead of the establishment of a natural or legal person, if trials are conducted on - their territory - or on their territory and the territory of a third country
  16. 16. Safety reporting (Art. 41 & 42 CTR) 16 - Investigator: report adverse events/lab abnormalities to sponsor. The protocol may provide that not all adverse events (AE) and serious adverse events are recorded and reported. - Sponsor: report SUSARs to EudraVigilance (if no resources available, reporting to MS where event occurred, MS to report to EV) - For IMPs (non-authorised or applied outside terms of marketing authorisation) an annual safety report to be submitted electronically to the Agency - For authorised IMPs: sponsor to inform the MAH of all SUSARs annually
  17. 17. Informed consent (Art. 28 – 30 CTR) 17 Detailed description of information and inclusion of - Patients in general - Incapacitated subjects (legal representative, adequate info, involvement in IC process as far as possible, presumed benefit) - Minors (legal representative, adequate info from trained individuals, involvement in IC process as far as possible, no incentives except compensation, direct benefit or group benefit) - Subjects in emergency situations (IC can be obtained after inclusion in life threatening or other sudden serious medical conditions, no legal representative available, no earlier expressed refusal to join a CT, no group benefit, minimal risk and burden, approval to be sought asap from legal representative and subject)
  18. 18. Transitory period of 3 years Until the CTR will become applicable, all clinical trials performed in the European Union are required to be conducted in accordance with the Clinical Trials Directive (2001/20). The Directive will be repealed as from 28 May 2016, but it will still apply three years from that day to: • Clinical trials applications submitted before the entry into application (no earlier than 28 May 2016) • Clinical trials applications submitted within one year after the entry into application if the sponsor opted for the old system During the transitory period the GCP and GMP Directives (2005/28 and 2003/94) apply to clinical trials authorised under the Clinical Trials Directive. 18
  19. 19. Guidelines The Commission is working on guidance documents in order to ensure a uniform application of the legislation on clinical trials in Europe. • Current guidelines are being revised • Revised and new guidelines are planned to be launched for public consultation in Q3 and Q4 of 2016 19
  20. 20. Overview main changes under CTR • Streamlined application procedure • Single set of documents for application (Annex I) • Harmonised procedure for assessment divided in two parts - Part I: joint assessment by all Member States - Part II: each Member State separately • Simplified reporting procedures • Increased transparency in trails and outcomes • Clinical trials outside EU, referred to in an application, have to comply with rules equivalent to EU rules. 20
  21. 21. Sofie van der Meulen Axon Advocaten Piet Heinkade 183 1019 HC Amsterdam +31 88 650 6500 +31 6 53 44 05 67 sofie.vandermeulen@axonlawyers.com

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