Orphan drugs have a special position under EU pharma laws. Among other things, the EU orphan drug laws grant the marketing authorization holder (MAH) of an orphan drug a 10 year period of so-called “market exclusivity”. According to Article 8(1) of the Regulation (EC) No. 141/2000 on orphan medicinal products, the EU and the EU
Germany plans significant hospital reform with broad impact on life sciences companies
Germany’s hospital system is reported to be of high quality but is also very expensive by international standards. Hospitals and healthcare payers such as health insurances are exposed to increasing economic constraints. One particular point of criticism is, for example, the current system of Diagnosis Related Group (DRG)-based fees.
Patient treatments are compensated based on the DRGs which effectively leads to a lump-sum payment system per diagnosis (with certain exemptions). This system has pros and cons. As a downside, it is reported to create incentives for over-treatments to generate DRG-based fees per patient.
At the same time, many hospitals in Germany are at risk of closure and insolvency due to financial challenges. The German federal states have thus asked the federal government for financial support to finance the restructuring of the hospital system and prevent hospitals from bankruptcy.
Pathogen Access and Benefit-Sharing (P-ABS) under the draft WHO Pandemic Treaty: Why Many Vaccine, Therapeutic, and Diagnostic Companies will be in Scope
By May 2024, the 194 countries of the World Health Organization (“WHO”) aim to finalize negotiations on a new international treaty on pandemic prevention, preparedness and response (“Pandemic Accord”). At the center of the negotiations is the contentious issue of Pathogen Access and Benefit-Sharing (“P-ABS”). In this blog we
Germany to enact new law with significant changes to drug pricing and reimbursement rules
In an earlier blog, we noted that the German drug pricing and reimbursement laws are among the most complicated legal areas in the entire field of life sciences law. Now, these laws and the respective German market access rules are becoming more complicated. A new law will come into effect in the next few weeks.
Germany plans Health Data Use Act and stricter pricing & reimbursement rules for Digital Health Apps
At the end of June 2023, a draft Health Data Use Act (“GDNG”) and a draft Digital Act (“DigiG”) of the German Federal Ministry of Health have become public. These drafts are part of the German government’s digitalization strategy for the health sector. The Health Data Use Act plans to grant industry companies an access right to patient health data for research purposes. The Digital Act envisages significant restrictions for the pricing and reimbursement of Digital Health Apps. Below, we summarize key aspects of these two legislation proposals.
EU Pharma Legislation Review Series: Unitary Supplementary Protection Certificates and Recast
On April 27, 2023 the European Commission (“Commission”) released its proposal to introduce a single procedure for the granting of Supplementary Protection Certificates (“SPCs”) throughout the EU. The changes are intended to complement the new unitary patent procedure that will enter into force on June 1, 2023. The Commission intends the new unitary SPC to
EU Pharma Legislation Review Series: New Classification Mechanism for Borderline Cases
Borderline issues arise when the regulatory classification of a product, for example, as a medicine, a medical device or a food supplement, is unclear. Uncertainty about the regulatory status of a product under development, and consequently uncertainty as to what legal rules need to be followed, can have immense consequences for developers and innovators. To
EU Pharma Revision Series: Pharmacovigilance
The European Commission’s proposal to amend the current pharmaceutical regulatory framework includes a draft Directive on medicines for human use (the “Proposed Directive”) and a draft Regulation on the central authorisation and supervision of medicines (the “Proposed Regulation”, together the “Proposal”). In this blog, we provide an overview of the potential impact of the Proposal
EU Pharma Legislation Review Series: Decentralized Manufacturing
The EU’s General Pharmaceutical Legislation amendment proposal, which was published on 26 April 2023 (“the Proposal”), is introducing new measures to regulate decentralized manufacturing, which is increasingly used for certain categories of medicinal products. In particular, the Proposal introduces new obligations for manufacturers and for national competent authorities overseeing decentralized sites. In this blog
EU Pharma Legislation Review Series: Supply Security and Shortages Control
As part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023 (“the Proposal”), the European Commission (“Commission”) has introduced a series of measures aimed at securing the supply of critical medicinal products across the EU and at preventing shortages. In particular, there are new obligations for Marketing Authorization Holders (“MAH”)