Delibera del Direttore Generale n. 457 del 31-08-2023
AZIENDA OSPEDALIERO UNIVERSITARIA XXXXX
Delibera del Direttore Generale n. 457 del 31-08-2023
Proposta n. 802 del 2023
Oggetto: ACCORDO CON XXXXX BIOPHARMA, INC. PER LA FORNITURA DI MEDICINALE SPERIMENTALE PER USO TERAPEUTICO – APPROVAZIONE SCHEMA DI ACCORDO
Dirigente: XXXXXXXX XXXXXXXXXX
Struttura Dirigente: RESPONSABILE AFFARI GENERALI E SVILUPPO
Delibera del Direttore Generale n. 457 firmata digitalmente il 31-08-2023
AZIENDA OSPEDALIERA UNIVERSITARIA XXXXX I.R.C.C.S.
Istituto di Ricovero e Cura a Carattere Scientifico Xxxxx Xxxxxxxxxx, 00 - 00000 XXXXXXX
C.F. P.Iva 02175680483
DELIBERAZIONE DEL DIRETTORE GENERALE
Oggetto | Contratto |
Contenuto | ACCORDO CON XXXXX BIOPHARMA, INC. PER LA FORNITURA DI MEDICINALE SPERIMENTALE PER USO TERAPEUTICO – APPROVAZIONE SCHEMA DI ACCORDO |
Area Tecnico Xxx.xx | AREA TECNICO AMMINISTRATIVA |
Coord. Area Tecnico Xxx.xx | XXXX XXXXX |
Struttura | AFFARI GENERALI E SVILUPPO |
Direttore della Struttura | XXXXXXXXXX XXXXXXXX |
Responsabile del procedimento | XXXXXXX XXXXXXXX |
Immediatamente Esecutiva | SI |
Spesa prevista | Conto Economico | Codice Conto | Anno Bilancio |
Estremi relativi ai principali documenti contenuti nel fascicolo | ||
Allegato | N° di pag. | Oggetto |
1 | 8 | Schema di accordo |
“documento firmato digitalmente”
IL DIRETTORE GENERALE
Visto il D. Lgs.vo n. 502 del 30.12.1992 recante “Riordino della disciplina in materia sanitaria” e s.m.i. e la
L. R. Toscana n. 40 del 24.02.2005 e s.m.i. di “Disciplina del Servizio Sanitario Regionale”;
Richiamata la L. R. Toscana n. 12 del 16.03.2023 “Disposizioni in materia di istituti di ricovero e cura a carattere scientifico pubblici. Modifiche alla l.r. 40/2005” con la quale si è proceduto alla disciplina degli istituti di ricovero e cura a carattere scientifico di diritto pubblico ed in particolare l’art. 13 con il quale sono state dettate le “Disposizioni transitorie per il passaggio da Azienda Ospedaliero Universitaria Xxxxx ad Azienda Ospedaliera Universitaria Xxxxx IRCCS…”;
Dato atto che:
- con deliberazione del Direttore Generale n. 54 del 01.02.2021 è stato approvato il nuovo Atto Aziendale dell’A.O.U. Xxxxx, ai sensi dell’art. 6 del Protocollo d’intesa del 22.04.2002 fra Regione Toscana e Università degli Studi di Firenze, Siena e Pisa, con decorrenza dal 01.02.2021;
- con deliberazione del Direttore Generale n. 55 del 01.02.2021 sono stati assunti i primi provvedimenti attuativi in relazione alla conferma/riassetto delle strutture complesse e semplici dotate di autonomia ed al conferimento dei relativi incarichi di direzione;
- con deliberazione del Direttore Generale n. 56 del 01.02.2021 sono state assunte determinazioni attuative del nuovo Atto aziendale in relazione alla conferma/riassetto delle strutture Dipartimentali e/o a valenza dipartimentale, delle Aree Funzionali Omogenee, dell’Area Servizi dell’Ospedale, dell’Area dei Diritti del Bambino, dell’Area Tecnico Amministrativa ed al conferimento di relativi incarichi di direzione;
- con successiva deliberazione del Direttore Generale n. 92 del 15.02.2021 si è provveduto ad assumere ulteriori disposizioni attuative relative all’organizzazione dell’A.O.U. Xxxxx in ordine alle Strutture semplici Intrasoc, Unità Professionali, Uffici e Incarichi professionali;
- con deliberazione del Direttore Generale n. 443 del 23.09.2022 l'A.O.U. Xxxxx ha disposto la presa d'atto del Decreto del Ministero della Salute del 02.08.2022, pubblicato nella Gazzetta Ufficiale n. 200 del 27.08.2022, con cui l’Azienda Ospedaliero Universitaria Xxxxx è stata riconosciuta Istituto di Ricovero e Cura a Carattere Scientifico (I.R.C.C.S.), per la disciplina di pediatria;
Su proposta del Responsabile della S.O.C Affari Generali e Sviluppo, Dr.ssa Xxxxxxxxxx Xxxxxxxx, la quale, con riferimento alla presente procedura, ne attesta la regolarità amministrativa e la legittimità dell’atto;
Premesso che questa Azienda, tra le proprie finalità istituzionali, promuove la cura in campo pediatrico offrendo livelli di eccellenza nel trattamento di malattie gravi o rare e che taluni medicinali in sperimentazione possono essere richiesti per uso terapeutico dai medici alle aziende farmaceutiche, ai sensi del DM 7 settembre 2017 avente ad oggetto “Disciplina dell’uso terapeutico di medicinale sottoposto a sperimentazione clinica”;
Atteso che il Dr. Xxxxxxx Xxxxxx, in servizio presso il Centro di Eccellenza di Oncologia ed Ematologia Pediatrica di questa Azienda, ha fatto richiesta al produttore Xxxxx Biopharma, Inc., di uso terapeutico di un medicinale sperimentale per un paziente affetto da patologia grave per la quale attualmente non sono disponibili altre valide alternative terapeutiche;
Specificato che il DM 7 settembre 2017 sopra richiamato prevede, inter alia, la possibilità di somministrare medicinali sottoposti a sperimentazione per i quali “in caso di malattie rare o tumori rari, (…) devono essere disponibili studi clinici sperimentali almeno di fase I, già conclusi e che abbiano documentato l’attività e la sicurezza del medicinale, ad una determinata dose e schedula di somministrazione, in indicazioni anche diverse da quella per la quale si richiede l’uso compassionevole. In tal caso la possibilità di ottenere un beneficio clinico dal medicinale deve essere ragionevolmente fondata in base al meccanismo d’azione ed agli effetti farmacodinamici del medicinale”;
Considerato che Xxxxx Biopharma, Inc. ha manifestato la propria disponibilità a fornire il suddetto farmaco per uso terapeutico e ha proposto un apposito Accordo per disciplinare i termini e le condizioni della fornitura a titolo gratuito del medicinale sperimentale;
Visto il parere favorevole del Comitato Etico della Regione Toscana – Pediatrico all’uso terapeutico del su citato medicinale sperimentale, espresso nella riunione telematica del 14.08.2023;
Stabilito che è tra gli impegni di questa Azienda provvedere alle migliori cure e terapie a favore dei pazienti, inclusi l’uso terapeutico di farmaci sperimentali laddove si presentino le condizioni terapeutiche definite dalla normativa applicabile;
Verificato che dall’Accordo di cui sopra non derivano oneri economici a carico dell’AOU Xxxxx IRCCS;
Ritenuto pertanto di stipulare l’Accordo per uso terapeutico di medicinale sperimentale con Xxxxx Biopharma, Inc. per la disciplina delle condizioni normative ed operative per la fornitura del farmaco da parte della predetta società farmaceutica che, allegato N. 1 al presente provvedimento, ne forma parte integrante e sostanziale;
Rilevata l’opportunità di dichiarare il presente atto immediatamente eseguibile al fine di formalizzare quanto prima l’Accordo con il produttore del medicinale sperimentale ed avviare in tempi brevi l’uso terapeutico del medicinale medesimo;
Considerato che il Responsabile del Procedimento, individuato ai sensi della Legge n. 241/1990 nella persona del Dr. Xxxxxxx Xxxxxxxx sottoscrivendo l’atto attesta che lo stesso, a seguito dell’istruttoria effettuata, nella forma e nella sostanza è legittimo;
Acquisito il parere del Coordinatore dell’Area Tecnico Amministrativa, Dr.ssa Xxxxx Xxxx, espresso mediante sottoscrizione del presente atto;
Vista la sottoscrizione del Direttore Sanitario e del Direttore Amministrativo, per quanto di competenza, ai sensi dell’art. 3 del Decreto Legislativo n. 229/99;
DELIBERA
Per quanto esposto in narrativa che espressamente si richiama,
1) Di prendere atto del parere favorevole all’uso terapeutico del medicinale sperimentale fornito da Xxxxx Biopharma, Inc. espresso dal Comitato Etico della Regione Toscana – Pediatrico nella seduta del 14.08.2023.
2) Di approvare lo schema di Accordo per uso terapeutico di medicinale sperimentale, da stipulare con Xxxxx Biopharma, Inc. che, allegato N. 1 al presente atto, ne forma parte integrante e sostanziale.
3) Di dare atto che dall’Accordo di cui sopra non derivano oneri economici a carico dell’AOU Xxxxx IRCCS.
4) Di dichiarare il presente atto immediatamente eseguibile ai sensi dell’art. 42, comma 4 della
L.R. T. n. 40/2005 in considerazione della necessità di consentire in tempi brevi l’accesso al medicinale sperimentale in regime di uso terapeutico.
5) Di trasmettere il presente atto al Collegio Sindacale ai sensi dell’art. 42, comma 2, della L.R.T. n. 40/2005 contemporaneamente all’inoltro all’albo di pubblicità degli atti di questa A.O.U. Xxxxx I.R.C.C.S.
IL DIRETTORE GENERALE | |
(Dr. Xxxxxxx Xxxxxxxx) | |
IL DIRETTORE SANITARIO | IL DIRETTORE AMMINISTRATIVO |
(Dr.ssa Xxxxxxxxx Xxxxxxx) | (Dr. Xxxx Xxxxx) |
CEO
Xxxxx Children’s Hospital IRCCS Xxxxx Xxxxxxx Xxxxxxxxxx 00 00000 Xxxxxxx – Xxxxx
and
Xxxxxxx Xxxxxx, MD
Oncology and Hematology Department Xxxxx Children’s Hospital IRCCS Xxxxx Xxxxxxx Xxxxxxxxxx 00
00000 Xxxxxxx – Italy
Re: Xxxxx Children’s Hospital’s Request for Compassionate Use of Sutro’s STRO-002
Dear Dr. Xxxxxxxx and Dr. Casini,
Xxxxx Biopharma, Inc. (“Xxxxx”) manufactures and has all title and proprietary rights to STRO-002, an investigational drug not yet available commercially in the United States and the European Union (“Product”). Xxxxx Children’s Hospital (“Institution”) has requested Xxxxx to supply the Product to use to treat certain patient(s) suffering from a certain life threating disease or condition for which no comparable or satisfactory alternative therapy is available (“Program”). The Program will be performed by Dr Xxxxxxx Xxxxxx of the Institution’s Oncology and Hematology Department.
Upon receipt of Institution’s signed acknowledgment and agreement to this letter and the terms and conditions contained herein (“Letter Agreement”), Xxxxx will supply to Institution the Product and any relevant documentation relating to the Product, free of charge, at the following address for Institution to use solely for the Program:
Product:
Name: Dr Xxxxx Xxxxx
Address: Pharmacy Hospital
Xxxxx Children’s Hospital IRCCS Xxxxx Xxxxxxx Xxxxxxxxxx 00 00000 Xxxxxxx – Italy
Documentation:
Name: Dr Xxxxxxx Xxxxxx
Address: Oncology and Hematology Department Xxxxx Children’s Hospital IRCCS Xxxxx Xxxxxxx Xxxxxxxxxx 00
00000 Xxxxxxx – Xxxxx
By signing this Letter Agreement, Institution hereby acknowledges and agrees to, and shall ensure, that its employees and agents, including the Investigator (as defined below) will adhere to the following terms and
conditions. These terms and conditions shall also govern Institution’s subsequent requests for the Product and Xxxxx’x supply thereof.
Terms and Conditions
Purpose
Institution shall only use the Product for the Program and not for any other purpose, and shall not, without Sutro’s prior written consent, make the Product available to any third party or patient, except as permitted herein.
Investigator
The Institution’s physician, Dr. Xxxxxxx Xxxxxx, shall be the principal investigator (“Investigator”) who shall be responsible for the performance of the Program and use of the Product in accordance with the terms of this Letter Agreement and all applicable laws. If, for any reason, Investigator is unable to continue to serve as the Investigator, then Xxxxx and Institution shall mutually agree on a successor investigator in writing. In the event that a successor investigator is not available, Xxxxx may terminate this Letter Agreement in accordance with the terms set forth below.
Patient’s Consent
Institution hereby acknowledges and accepts all personal responsibility for obtaining all necessary consents from each patient (or their legal representatives, where applicable) and all medical responsibility for the use of the Product and treatment of the patient. Institution shall ensure that each patient has been sufficiently informed: (1) that the Product has not been approved or is not yet commercially available in the United States and the European Union; and (2) on the possible risks and benefits of the Product as well as other therapies that may be available. Institution is also responsible for obtaining the patient’s consent in accordance with applicable laws and regulations and Institution’s policies prior to treatment with the Product. Institution shall, and Investigator will, ensure the patient consent form includes the minimum requirements set forth in Exhibit 1.
Authorizations
Institution shall obtain all relevant authorizations from Health Authorities and the Ethics Committees pursuant to applicable laws and regulations. Institution shall promptly send all such approvals to Xxxxx for records-keeping purposes.
Safety Reporting
Institution agrees to be responsible for reporting any adverse events and other relevant safety information to Institution’s local Health Authority and Ethics Committee(s) according to Institution’s local regulations
1) Any Serious Adverse Events (SAEs) (including initial and follow up reports) in patient(s) exposed to the Product; and
2) Any safety reports submitted to any applicable Health Authority and Ethics Committee/IRB in accordance with the applicable laws and regulations (including initial and follow up reports) in patient(s) exposed to the Product.
Xxxxx will prepare and provide to the Investigator Safety Notifications (SNs) for the Product (e.g.: Aggregate Finding Safety Reports (AFSRs), Single Suspected Unexpected Serious Adverse Reactions (SUSARs), six-monthly SUSAR line listings, Investigator Notifications, Urgent Safety Measures (USM)), post-parent trial completion and any risk management or risk minimization measure in accordance with Sutro’s internal procedures. The Investigator shall distribute such SNs to local Ethics Committee/IRB in accordance with applicable laws and regulations.
Injury and Medical Treatment
Institution acknowledges and agrees that Xxxxx shall not be liable or responsible for any physical injuries to any patient and that if the Program results in any injury to a patient, no form of compensation will be provided by Xxxxx. Medical treatment may be provided at the patient’s own expense or at the expense of the patient’s health care insurer, which may or may not provide coverage.
Updates and Reporting
The Investigator shall provide regular updates to Xxxxx regarding the efficacy of the Product in the treatment of the patient, including redacted clinic notes that include clinical course, laboratory values, assessments of radiographic and non-radiographic disease response/progression, results from bone marrow aspiration and biopsy, any other imaging scans, hematology, and metabolic and chemistry laboratory tests after every cycle of treatment. Institution shall, and shall ensure that Investigator, redacts any personal patient information that could be used to identify the patient prior to providing such information to Xxxxx. Institution also agrees to fulfill the following responsibilities:
(a) Preparation and maintenance of complete and accurately written patient record relating to the use of the Product.
(b) Management of Product Supplies: inventory, expiry dates, Product utilization must be recorded in accordance with applicable laws and regulations. Institution shall promptly collaborate with Xxxxx in case of a Product recall.
(c) Management (collection, possession, storage, use, retention, deletion, etc.) of personal information of patient(s) in compliance with all applicable privacy laws.
(d) Preparation and submission of Program related reports required by applicable laws and regulations, including applicable health authorities, and providing a copy of such to Xxxxx within one (1) month of issuance.
(e) Informing Xxxxx when any patient is discontinued from treatment.
(f) Informing the patient on the switch to a commercial Product, if applicable, and the potential impact on associated costs.
Pharmacokinetic Samples and Compensation
Institution acknowledges that information regarding the Product’s effect on the patient during the course of the Program is valuable to determine whether dose or schedule modification is advisable for the patient, and Institution agrees to collect, process, and provide to Xxxxx pharmacokinetic samples in accordance with the table below. Xxxxx agrees to compensate Institution for the time and expense expended in the collection, processing, and shipping of such pharmacokinetic samples. Any sample will be shipped as anonymized, with no code that can be used to re-identify the patient. Upon receipt of Institution’s invoice description the timepoints below, Xxxxx shall pay the fees in accordance with the table below within thirty (30) days:
Dose # | Timepoints | Fee per each Timepoint | Total Fees |
1 | Pre-dose, 5-minute post-dose, 24-hour post-dose, 1-week post-dose | $90.00 | $360.00 |
2 and more | Pre-dose, 5-minute post-dose | $90.00 | $180.00 |
Insurance
Institution hereby certifies that the Institution has appropriate and adequate insurance coverage to cover any claims and damages for which it shall be liable under this Letter Agreement and agrees to present evidence of such insurance to Xxxxx upon request. Institution declares that self-insurance for civil liability applies on its side, in accordance with Tuscany Regional Law No. 1203 of 21.12.2009.
Confidentiality
Institution and Investigator shall not disclose, by publication or otherwise, to any third party or use for any purpose except as expressly permitted under this Letter Agreement, any information disclosed to Institution and developed by Institution, alone or together with others, in connection with this Letter Agreement (collectively “Information”). This obligation of non-disclosure and non-use shall not apply to: (i) Information that it is or becomes available to the public through no breach of this Letter Agreement by Institution; (ii) Information that is already independently known to Institution as shown by Institution’s prior written records; (iii) Information that is disclosed to Institution without an obligation of confidentiality by a third party other than Xxxxx; (iv) Information that is independently developed by Institution without use of or reliance on Information; or (v) Information that is necessary for the appropriate medical care of patient(s) treated in the Program. To the extent Institution is required (whether by statute, regulation, law or order of a court of competent jurisdiction) to disclose any Information, Institution will provide Xxxxx written notice of such requirement prior to disclosing such Information to enable Xxxxx to seek a protective order or other appropriate remedy, and Institution will disclose only that portion of Information that Institution is legally required to disclose. Institution’s non-disclosure and non-use obligations herein shall survive the termination or expiration of this Letter Agreement for a period of five (5) years.
Xxxxx Data Security
Institution represents that it has implemented and will maintain appropriate administrative, technical and physical measures, including information security policies and safeguards, to protect all Xxxxx information, including Information, against accidental or unlawful destruction, alteration, disclosure or access in accordance with industry practices and applicable laws. Institution shall ensure that any telecommunications equipment and systems, regardless of its location, that is used by Institution or Investigator, either directly or indirectly, to retrieve, store, manipulate, manage, control, display, interchange, transmit, or process any Xxxxx information, including Information, adequately and effectively protects the integrity, availability, and confidentiality of all Xxxxx information. Institution shall ensure its Investigator, employees, and agents fully comply with Institution’s obligations hereunder and if Institution becomes aware of a security breach that compromise the security, confidentiality, or integrity of Xxxxx information, Institution will take appropriate actions to contain, investigate and mitigate such breach and promptly notify Xxxxx.
Intellectual Property
Product is and shall remain the sole property of Xxxxx. The transfer of Product to Institution hereunder, or use of Product by Institution and Investigator, shall neither constitute nor be construed as transfer of title to the Product. Any inventions or discoveries (whether patentable or not), innovations, suggestions, ideas, work product, results and reports made or developed by Institution, Investigator or other employees and agents of Institution during the course of this Program (“Inventions”) shall be promptly disclosed to Xxxxx and shall become, be, and remain the sole and exclusive property of Xxxxx. Institution hereby assigns and shall ensure that its employees and agents including Investigator assigns, all right, title, and interest to all Inventions to Xxxxx. Upon Xxxxx’x request and at Xxxxx’x expense, Institution shall take actions deemed necessary by Xxxxx to perfect Sutro’s exclusive ownership of Inventions and obtain patent or other proprietary protection in Sutro’s name with respect to any such Inventions.
Publication Rights
Should Institution or Investigator wish to publish anything related to Institution’s use of the Product, Institution, as the applicable party seeking to publish, shall give Xxxxx the opportunity to review and comment on the proposed publication at least forty-five (45) working days for manuscripts, and at least thirty (30) working days for papers, posters, oral presentations and disclosures, and abstracts prior to submission of the proposed publication to any third party. Upon Xxxxx’x request, Institution shall delete all confidential information, including Information, from the proposed publication to the extent such deletion does not preclude the complete and accurate presentation and interpretation of the Program results. In addition, Xxxxx may require any proposed publication to be delayed for up to forty-five (45) days commencing on the date of receipt of the proposed publication.
Term and Termination
This Letter Agreement shall become effective as of the last date of Institution’s acceptance signature and Investigator’s acknowledgment signature of this signed Letter Agreement and shall continue until the Program patient no longer meet(s) established eligibility criteria for the Product administration or until the Product is commercially available in the United States, whichever occurs first. Additionally, either party shall have the right to terminate this Letter Agreement earlier at its sole discretion upon providing thirty
(30) days written notice to the other party (subject to local laws and regulations). Termination shall not relieve any party of its obligations accrued prior to the termination date. Within thirty (30) days following termination or expiration of this Letter Agreement, Xxxxx will provide Institution instructions on the management of any unused Product, including the return of the Product, with no shipping costs to be paid by Institution. The provisions in this Letter Agreement which by their nature are intended to survive the termination or expiration of this Letter Agreement shall survive.
Miscellaneous
Institution hereby acknowledges and agrees that Institution and Investigator are acting independently of Xxxxx in the provision and use of the Product, that the performance of the Program is free from undue influence or bias, and that Institution and Investigator are not entering into this Letter Agreement in exchange for any explicit or implicit agreement to prescribe, recommend, purchase, supply, dispense, administer, or provide favorable status for any Xxxxx drug product. Institution hereby acknowledges and agrees that the Program or the use of or providing Product to the Program patient does not constitute an opinion or statement that the Product is safe or efficacious for a given indication.
Institution on behalf of itself and Investigator certifies that neither the Institution, Investigator nor any person employed by or under contract with the Institution in connection with the performance of the Program or performance under this Letter Agreement, including without limitation, any research performed hereunder has been (i) convicted of an offense related to any Federal or State healthcare program, including (but not limited to) those within the scope of 42 U.S.C. §1320a-7(a); (ii) excluded, suspended or is otherwise
If any employee of the Institution involved with the performance of the Program or performance under this Letter Agreement is currently or during the term of this Letter Agreement becomes a member of a committee that sets formularies of covered medicines (e.g., formulary committee or Pharmacy & Therapeutics committee) or develops clinical practice guidelines or treatment protocols or standards, such person shall comply with the disclosure requirements of the respective committee(s) and, at minimum, shall follow the procedures of such committee and disclose to such committee that such person(s) provide services to Xxxxx related to clinical research activities relating to the Product. The obligation to disclose to such committee as contemplated in this paragraph shall extend for two (2) years beyond the termination or expiration of this Letter Agreement, or a longer period of time as required by such committee. If and to the extent that the procedures or the disclosure requirements of any committee(s) referenced above of which such person is a member requires disclosure of Information to such committee(s), the Institution or Investigator will notify Xxxxx of such requirement reasonably in advance of making such disclosure, to the extent not prohibited by the policies of such committee(s).
This Letter Agreement shall be governed, construed and interpreted pursuant to and in accordance with the laws of the State of Delaware. This Letter Agreement represents the entire agreement of the parties concerning the Program and Institution’s use of the Product, and expressly supersedes all previous written and oral communications between the parties regarding such matter. No amendment, alteration, or modification of this Letter Agreement or any exhibits attached hereto shall be valid unless executed in writing by authorized signatories of both parties.
Please acknowledge your agreement to the foregoing by having an authorized representative sign and date below. Please contact Xxxx Xxxxxx, Clinical Trial Manager at xxxxxxx@xxxxxxxx.xxx should you have any questions. Thank you.
Sincerely,
Xxxx Xxxxxxx
Chief Medical Officer Xxxxx Biopharma, Inc.
Acceptance Signature Page to Follow
By signing this Letter Agreement, Institution hereby acknowledges and agrees to all terms and conditions set forth therein.
Acknowledged and Agreed to by | Read and Acknowledged by |
Xxxxx Children’s Hospital IRCCS | INVESTIGATOR |
By: Signature of authorized representative Name: Title: CEO Date Signed: | By: Signature of Investigator Name: Xxxxxxx Xxxxxx Title: MD Date Signed: |
EXHIBIT 1
Key items for the Investigator to include in the Patient Consent
The following minimum requirements shall be included in the patient informed consent taking into consideration any local applicable regulations:
• Information that product is not yet authorized (pre-approval access) or unavailable or not yet available to the patient in a particular country (post-approval access)
• Background information on the product including previous results from clinical trials (why product may help the patient without promising any benefits)
• General information on treatment, which procedures physician will perform to administer the product/monitor the patient, what is expected of the patient
• Information on identified and potential risks and side effects
• Information that treatment is voluntary, patient can drop out at any time
• Information on what happens after conclusion of treatment and when treatment can be terminated (e.g. loss of patient benefit from the treatment, consent withdrawn, serious adverse events etc.)
• Information on free of charge supply (if applicable)
• Provision addressing liability in accordance with local law
• Clear privacy wording for the collection and processing of patient´s personal data.
• Information on collection of follow-up information at the time of resupply to understand how the patient is deriving benefit, if applicable
• Notification that some information might be aggregated and processed in a de-identified/coded way for further analysis and for publication
• Investigator shall inform IRB/EC as required by applicable regulations.