Should GSAV regulations be increased for orphan medicines?

The Pharmareport by the BPI – Bundesverband der Pharmazeutischen Industrie (Association of the Pharmaceutical Industry) presents the case for and against increased legal implications to orphan drugs under the GSAV – Gesetz für mehr Sicherheit in der Arzneimittelversorgung (law for more safety in the supply of pharmaceuticals).

Arguing the case for more regulations Professor Josef Hecken, Chairman of the G-BA – Gemeinsamer Bundesauss (Federal Joint Committee) said:

“[Benefit assessment] is a good and practical way for the G-BA to request the application-accompanying data surveys if there is insufficient evidence. There are indications in which are either impossible or inappropriate to require the highest level of evidence for the approval phase. However for a quality-assured and economic use of orphan drugs, there is also the need for reliable evidence in the interest of patients and the insured.”

While arguing the case against Christian Thams, Senior Director of Government Affairs from Gilead Sciences in Germany says:

“The existing regulations on orphan drugs give many patients with rare diseases access to innovative therapies and integrate them into our health system. Changes to the reimbursement policy is welcomed by patients, physicians, academia, health insurances and companies. However the possible sanctions [or penalties] to the benefit assessment to orphan drugs as per the GSAV are not necessary. On the other hand, reducing turnover threshold or the individually determined data collections are unforeseeable uncertainties for the development of new therapies and patient care.”

MAP will be closely following developments in the GSAV.

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Published 3. May 2019 in News Germany