AMNOG Advisory Services

Dr. Meriem Bouslouk-Marx

Dr. Meriem Bouslouk-Marx is AMNOG Expert and Founder of MBM Future Health. She has comprehensive experience in the assessment of new pharmaceuticals and the procedures at Germany’s top health policy body, the Federal Joint Committee (G-BA). When Germany introduced AMNOG, the legislation on the benefit assessment of new innovative medicines, in 2011, she joined the initial small team at the G-BA in charge of implementing the procedure. In this position, she prepared binding national decisions.
Her main responsibilities included conducting consultations with industry and regulatory authorities on clinical trial design and endpoints, assessing the submitted evidence and drafting G-BA resolutions under AMNOG. Equipped with her knowledge of neglected diseases, she conceptualised and coordinated the specific German policy procedure for the assessment of new orphan drugs. Her daily work included interaction with various stakeholders, reaching from healthcare payers, healthcare providers, patients and their affiliations to pharmaceutical manufacturers and associations.
Special time-limited permission to be on leave from the Pharmaceuticals Department was granted in 2016 to set up the G-BA’s new Innovation Committee after the introduction of Germany’s Innovation Fund. Furthermore, Meriem was entrusted to promote the G-BA’s work at international level, which became a real passion: she gave lectures and speeches – within and outside of the G-BA – and strengthened partnerships with other European and international organisations.

Meriem left the G-BA in December 2019 to concentrate on her work with MBM Future Health. Her clients include small and medium-sized enterprises in the field of rare diseases. Until today, she keeps up international communication as an asset for her business. Besides German, she speaks French, Arabic and English and has basic knowledge of Spanish.
Meriem holds a Master of Science in International Health from the Charité, Berlin. At the beginning of her career, she focused on international healthcare cooperation. She considers the mix of integrity and enthusiasm as best value.

in action

Lecturer in Market Access, Pricing & Reimbursement at the European Market Access University Diploma (EMAUD) programme since 2011.
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Orphan Cell and Gene Therapy Expert with Sindusfarma at the Brazilian Health Regulatory Agency Anvisa. GENE AND ADVANCED THERAPIES: Creating Value in the Patient Journey and the Health System.
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Orphan ATMP Expert with the Alliance for Regenerative Medicine. Getting Ready: Recommendations for Timely Access to Advanced Therapy Medicinal Products (ATMPs) in Europe.

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in references

AMED, Japan Agency for Medical Research and Development (2020) Development Trend Survey of Ultra Orphan Drugs.

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Schoonveld, E. (2020). The Price of Global Health: Drug Pricing Strategies to Balance Patient Access and the Funding of Innovation (3rd ed.). Routledge.
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Korchagina D., Jaroslawski S., Jadot G., Toumi M. (2019) Orphan Drugs in Oncology. In: Walter E. (eds) Regulatory and Economic Aspects in Oncology. Recent Results in Cancer Research, vol 213. Springer, Cham.
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OECD (2018) Pharmaceutical Reimbursement and Pricing in Germany.
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AMNOG Advisory Services

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AMNOG Benefit Assessment

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Mit der EMA auf der Überholspur

Mit der EMA auf der Überholspur

Article published in Tagesspiegel Background Gesundheit & E-Health on 26 February 2021

Im Standpunkt ordnet Arzneimittel-Expertin Meriem Bouslouk-Marx die politischen Entscheidungen und Verfahren in Deutschland und der EU zur Zulassung und Verteilung von Impfstoffen auch vor dem Hintergrund öffentlich geäußerter Kritik ein.

With EMA on the fast track
Pharmaceutical expert Meriem Bouslouk-Marx takes a stance on the political decisions and procedures for approval and distribution of vaccines in Germany and in the EU, also in the light of public criticism.

Efficacy Controversy Hits European COVID-19 Vaccine Rollout

Article published in Pharmaceutical Executive

Donald Macarthur and Dr. Meriem Bouslouk-Marx discuss post-approval findings of national committees in Europe charged with deciding the best strategy to use a new COVID-19 vaccine in their populations.

By end-January 2021, three COVID-19 vaccines had received conditional marketing authorizations (valid one year) by the European Commission…

G-BA benefit assessment of new orphan drugs in Germany: the first five years

Article published in Expert Opinion on Orphan Drugs

The January 2011 introduction of benefit assessment through the Act on the Reform of the Market for Medicinal Products in Germany, better known as AMNOG (Arzneimittelmarktneuordnungsgesetz), created a new way to assess the value of patented medicines at the time of launch for use as a basis to determine their ongoing reimbursement. This Act was basically intended to counteract increasing drug prices…

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