Vitiligo: equal rights for EU citizens

Subject: Vitiligo: equal rights for EU citizens

Skin diseases are a serious global public health burden. Although they are rarely life threatening, they have huge physical, psychological and social consequences.

Vitiligo is one of the most invasive skin diseases, which affects almost 100 million people worldwide. While not painful, this complex disease entails the autoimmune destruction of epidermal melanocytes and has a significant impact on the personal and social life of patients, causing embarrassment, shame and depression.

On 19 April 2023, the European Medicines Agency authorised the use of Opzelura, a new medicine for treating non-segmental vitiligo. Two main studies have proved that this treatment can achieve an improvement in pigmentation of at least 75 % after six months. Nevertheless, this medicine is very expensive and it has still only been commercialised in a few Member States.

In the light of the above and taking account of its remit, can the Commission say whether:

1. It intends to engage with the Member States to recommend the recognition of vitiligo as an autoimmune disorder beyond its cosmetic implications?

2. It will take action to include vitiligo in EU research funding mechanisms, such as Horizon Europe and the Innovative Health Initiative, in order to improve the lives of vitiligo patients?

3. It will consider recommending that all Member States provide innovative treatments, such as Opzelura, free of charge or at a reduced price?

Submitted:24.7.2023

Answer given by Ms Kyriakides on behalf of the European Commission

(18 September 2023)

In June 2022 the Commission presented the ‘Healthier Together’ initiative (1), through which the Commission is working together with Member States in the Public Health Expert Group as well as with stakeholders to address the major non-communicable diseases.

A total budget of EUR 156 million is available under the EU4Health 2022 work programme (2) to support Member States and stakeholders in the implementation of the initiative. In this context, Member States may decide to prioritise or consider skin diseases, including vitiligo.

Vitiligo research falls under the broader domain of immune-mediated diseases, both common and rare diseases (3), which has been the subject of research of several EU projects supported via the EU framework programmes for research and innovation, such as INFLA-AID (4) and ImmunAID (5).

Furthermore, the EU supports research on regenerative medicine, such as cell therapies, which is of relevance to vitilig o (6) (7). In addition to this, the Innovative Health Initiative (IHI) (8), a new public-private partnership between the EU and the health industry, under Horizon Europe, provides opportunities and already supports a project tackling skin diseases like atopic dermatitis and psoriasis (9).

1 ∙ ⸱ https://health.ec.europa.eu/non-communicable-diseases/healthier-together-eu-non-communicable-diseases-initiative_en

2 ∙ ⸱ https://health.ec.europa.eu/publications/2022-eu4health-work-programme_en

3 ∙ ⸱ The European Joint Programme on Rare Diseases: https://www.ejprarediseases.org/

4 ∙ ⸱ INFLA-AID: The role of NLRC4 inflammasome in autoinflammatory diseases: https://cordis.europa.eu/project/id/798068

5 ∙ ⸱ Immunome project consortium for AutoInflammatory Disorders: https://cordis.europa.eu/project/id/779295

6 ∙ ⸱ EUROSKINGRAFT: A novel generation of skin substitutes to clinically treat a broad spectrum of severe skin defects: https://cordis.europa.eu/project/id/279024

7 ∙ ⸱ ‘Trooping the color’: restoring the original donor skin color by addition of melanocytes to bioengineered skin analogs:

https://link.springer.com/article/10.1007/s00383-012-3217-0

8 ∙ ⸱ Innovative Health Initiative: https://www.ihi.europa.eu/

9 ∙ ⸱ BIOMAP project: https://biomap-imi.eu/


















| | )The Commission fully respects the competences of Member States in the area of pricing and reimbursement. In line with the Pharmaceutical Strategy for Europe (10), the Commission’s activity focuses on supporting cooperation and exchange of best practices between national Pricing and Reimbursement Authorities and healthcare payers, including to foster patient access to innovative and affordable medicines.

10 ∙ ⸱ https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe_en | | ( | | )