2018 VALUE ADDED MEDICINES AWARD 2018 WINNERS

Category 1 – ‘Be Educated and Empowered Patient (BEEP) Program’ – Education program for organ transplanted patients organised by The Hungarian Transplant Federation http://www.trapilap.hu/

Category 2 – ‘Keramod® Gel’ – an innovative 5% Imiquimod film-forming formulation to enhance patient´s compliance by reducing side effects developed by Laboratorios Ojer Pharma https://lnkd.in/d_dBKFE More information about the prize winners will be available in the coming weeks!

Regulation of the Value Added Medicines Award 2018

1. Objective

The value added medicines sector group of Medicines for Europe intends, under the terms and conditions set forth in this regulation, to award 2 projects:

1) Initiatives/campaigns that aim to improve patient quality of life and/or adherence and/or demonstrate relevant value added benefits on existing treatments,

2) Scientific research/projects led by academics/healthcare professionals that aim to improve existing treatment adherence and/or convenience and/or patients’ preferences and/or demonstrate relevant value added benefits for patients,

in order to promote awareness, and to promote more initiatives and research in these areas. From now on, both 1) and 2) will be named ‘projects’.

The submission of the projects by the applicants implies their acceptance and binding to the present regulation.

2. Divulgation

The value added medicines award will be announced in the following ways:

  • On the website of Medicines for Europe
  • Via e-mails to Universities, Healthcare centres, healthcare societies and/or associations
  • Via social media (e.g. Twitter; LinkedIn)

3. Applicants

  • The application is free of charge
  • The projects can be submitted by a single person (“Singular Application”) or by a group of people (“Collective Application”)
    • In the case of a Collective Application, the applicants must appoint a representative, who shall act on behalf of the group, and who shall perform the following functions:
      • Represent the group with Medicines for Europe and the Evaluation Committee, providing all the information requested by them;
      • Receive the award, if applicable;
      • Respect all the conditions provided in this Regulation.
  • All applicants are required to comply with the following eligibility conditions:
    • People with employment, internship or membership of Medicines for Europe cannot apply for this award. Family members up to the 2nd grade of any Medicines for Europe employee cannot apply. Members of the Evaluation Committee and family members up to the 2nd grade of any member of the Evaluation Committee cannot apply for this award.
  • Each applicant or group of applicants may submit an unlimited number of applications, taking into account that each of the submissions must relate to different projects.

4. Requirements for the project

The projects to be submitted must comply with the following requirements (please see requirements for each of the 2 awards below):

1) Initiatives/campaigns that aim to improve patient quality of life and/or adherence and/or demonstrate relevant value added benefits on existing treatments

  • They must have been elaborated within the framework of an initiative that envisioned the improvement of patients’ quality of life, having been completed by the applicant(s) and, where applicable, have been authorised by the relevant regulatory authorities, including the institution where the candidate(s) performs functions and/or where the project is taking place;
  • The initiative(s) cannot infringe the rights of third parties, including intellectual property, and the applicant(s) are solely responsible for collecting the corresponding authorisations, if necessary and responsible for any violations that they will practice, being the responsibility shared in the case that the applicants are a group of people;
  • They must be novel initiatives that were developed in the last three years
  • They may not contain identifiable personal data of third parties
  • Your submission to the present initiative must have been duly authorised by the institution(s) in which the candidate (s) performs functions and/or where the project took place.

2) Scientific research/projects led by academics/healthcare professionals that aim to improve existing treatment adherence and/or convenience and/or patients’ preferences and/or demonstrate relevant value added benefits for patients

  • They must have been elaborated within the framework of a scientific research project in the areas of adherence and/or convenience and/or patients’ preferences research, having been completed by the applicant(s) and, where applicable, have been authorised by the relevant regulatory authorities, including the institution where the candidate(s) performs functions and/or where the project is taking place;
  • They must be authored by the applicant(s) and cannot infringe the rights of third parties, including intellectual property, and the applicant(s) are solely responsible for collecting the corresponding authorisations, if necessary and responsible for any violations that they will practice, being the responsibility shared in the case that the applicants are a group of people;
  • They must be original (can be published or unpublished projects) resulting from research projects developed, totally or partially, in the last three years, being able to integrate own published scientific results in the scope of the development of the mentioned project
  • They may not contain identifiable personal data of third parties
  • Your submission to the present initiative must have been duly authorized by the institution(s) in which the candidate (s) performs functions and/or where the project took place
  • For the purposes of this Regulation, the ‘scientific research/project’ means any project that includes empirical research and fieldwork (laboratory, medical, social or otherwise) including, but not limited to, clinical trials and excluding projects that translate into mere collection and treatment of information already contained in articles and writings of others.

5. Presentation of Applications

Applications must be submitted to the email cpereira@medicinesforeurope.com in which the applicant(s) should indicate and join the following:

Information on applicants:

In the case of a Singular Application:

(a) an Applicants’ Declaration, which requires the following data to be completed:

  • Full name
  • Nationality
  • ID/passport number
  • Contact e-mail/direct phone number
  • A statement with the intent of the application
  • A statement with 1) the intent of application and 2) which of the projects the applicant intends to apply (please see section 1 objectives)

In the case of a Collective Application:

(a) an Applicants’ Declaration, which requires the following data to be completed:

  • Full name
  • Nationality
  • ID/passport number
  • Contact e-mail/direct phone number
  • A statement with 1) the intent of application and 2) which of the projects the applicant intends to apply (please see section 1 objectives)

(b) the Representative’s Statement – statement where the group responsible for the work/institution nominates one representative for the group.

Information on the project:

  • Title of the project
  • Identification of the institution(s) where the project was carried out
  • Date of completion of the project
  • Additional Documentation:
    • Curriculum vitae of the candidate(s) (if applicable, a list of scientific publications (e.g. scientific project submission))
  • Project description (maximum 3 pages)
    • The project must contain the following information, in the order indicated below:
      • Title of project
      • Identification of the author(s) and institution(s) where the project was carried out
      • Summary of the project in English
        • Introduction
        • Objectives and rationale
        • Results/outcomes
        • Annexes (e.g. brochure, infographics, picture)

If research project, please also include:

        • Materials and methods
        • Discussion and conclusions
        • References
      • The submission of the information of the project must be written in English.
  • Applications must be sent to the e-mail cpereira@medicinesforeurope.com until 6 November 2018 (23:59 CET) with the following subject on the e-mail: ‘value added medicines award 2018’
    • Medicines for Europe is not responsible for the possible loss and non-receipt of applications caused by interruptions or network failures.
    • Applicants’ e-mails must be active and up-to-date throughout the duration of this initiative.

6. Responsibility for the content of the project submitted

  • Applicants are responsible for all information and content that they make available in the submitted project (being jointly responsible for compliance with this regulation and for the project in the case of Collective Applications). The applicants must ensure that:
    • They comply with the conditions set out in the regulation
    • Submissions do not contain illegal, false, misleading, malicious, ethical, abusive, racially, morally objectionable or harmful to the dignity of a person
    • The submitted project do not violate the rights of third parties nor the applicable law
    • In the case the submitted projects are based on a clinical study, the applicant is responsible for ensuring that the applicable legislation was respected and that they are entitled to disclose the results of the respective study
    • The projects that served as the basis for the submission to the award presented in this regulation, were, if applicable, authorised by the competent regulatory authorities, including the institution(s) where the candidates perform their functions and/or where the project was carried out
    • They have obtained the necessary authorisations from the competent authorities for animal or human experimentation, if applicable
    • Who obtained authorisation or notification issued by the respective (National) Data Protection Commission, in case of processing of personal data of third parties
    • They comply with the pharmacovigilance obligations set by law in the country(s) where the project was set, if applicable
    • You acknowledge and agree that, should you be the winner, Medicines for Europe may disclose if required by the statutory or deontological standards to which it is subject, and by the means it understands or is obligated to, information regarding the Value added medicines award, including the identification of the winner(s) and the respective reward;

Medicines for Europe reserves the right to exclude projects that do not comply with the provisions of this Regulation. In particular, if it considers that they violate the rights of third parties or if it was requested by the holders of intellectual property rights on elements included in the projects and/or administrative or judicial decision(s).

7. Selection of applications

The value added medicines sector group of Medicines for Europe will have the following competencies:

  • Receipt of applications
  • Verification of the conformity of the Applications with the provisions of the regulation presented in this document
  • Communication of information to applicants related to the value added medicines award.

If the value added medicines sector group of Medicines for Europe finds that there are Applications that do not comply with the provisions of this Regulation, the application will be unfortunately denied.

8. Evaluation of the projects

The project(s) will be evaluated by an Evaluation Committee, consisting of:

  • Participants with recognised merit in a patients’ group/association at European level
  • Participants with recognised merit in a healthcare professional group/society/research group at European level
  • Participants with recognised merit in the healthcare field at European level

The Evaluation Committee shall also consist of:

  • One representative of the value added medicines sector group, and/or the coordinator of the value added medicines sector group, and/or the communications manager of Medicines for Europe.

If deemed necessary and for the good appreciation of the projects, the members of the Evaluation Committee may use the support of specialised scientific societies or any other information relevant in the areas related to the projects selected by the value added medicines sector group and/or the Evaluation Committee.

The names for the constitution of the Evaluation Committee will be proposed by the value added medicines sector group of Medicines for Europe.

The Evaluation Committee will evaluate the projects according to the following criteria:

1) Initiatives/campaigns that aim to improve patient quality of life and/or adherence and/or demonstrate relevant value added benefits on existing treatments

  • Impact on patients’ quality of life
  • Practical applicability of the project
  • Originality/innovativeness of the project

2) Scientific research/projects led by academics/healthcare professionals that aim to improve existing treatment adherence and/or convenience and/or patients’ preferences and/or demonstrate relevant value added benefits for patients,

  • Impact on patients’ quality of life
  • Practical applicability of the project
  • Originality/innovativeness of the project
  • Scientific merit/robustness

The decisions of the Evaluation Committee are taken by an absolute majority of votes and are sovereign and irrevocable, without any type of appeal.

The Evaluation Committee reserves the right to request information and/or clarification from the applicants or their representatives, as the case may be, on the content of the projects, if it deems fit to an adequate evaluation of the projects.

The Evaluation Committee reserves the right to not select any of the projects if none meets the intended quality requirements.

9. Disclosure of the winner

The winners of the value added medicines awards will be announced by the end of November 2018.

The value added medicines sector group of Medicines for Europe will contact the winners or representatives of the winning group (as applicable), by telephone and/or email to announce that they were the winners of the awards.

The public session for the awarding of the value added medicines awards will be on a date to be defined, taking place, in principle, until the end of 2018.

10. Reward of the awards

The reward of the ‘value added medicines award’:

For each project:

  • 2500€
  • Free pass for Medicines for Europe conferences (6 conferences)
  • If the applicant meets the criteria to become a member of Medicines for Europe: 1-year membership fee

Medicines for Europe will contact the winners after the communication of the winning award to request additional information deemed necessary for the allocation and use of the reward.

11. Intellectual Property Rights

Award winners grant Medicines for Europe a perpetual, worldwide, non-exclusive, free, transferable and sublicensable license to use, modify, translate and use in conjunction with or in other projects, reproduce, distribute, disseminate, communicate to the public without limitation of the means, place or form, the information on the project(s) submitted by the applicant, for any intended purposes, including but not limited to dissemination/promotion actions of this initiative, future initiatives and/or projects, mentioning always their authors.

12. Personal Information

Medicines for Europe is the entity responsible for the processing of personal data processed under this initiative.

13. Calendar

Deadline for applications/receipt of works for the competition: 23:59 CET on 6 November, 2018.

The announcement of the winners: until the end of November 2018.

14. Clarifications and final provisions

For any additional clarification, applicants should send an email to cpereira@medicinesforeurope.com

The value added medicines sector group of Medicines for Europe reserves the right to amend this Regulation at any time, including the members of the Evaluation Committee and the time limits set forth herein.

The Value Added Medicines Group

The Value Added Medicines Group is a sector group of Medicines for Europe which aims at optimizing, rethinking and reinventing medicines based on known molecules and by bringing untapped innovation to improve care delivery. The Value Added Medicines Group adopts a complementary perspective compared to the other Medicines for Europe sector groups: by tackling the targeted portion of patients’ needs that remain unmet to this day, delivering additional improvement to the healthcare community as a whole.