The EHDS is about data, not bodily material. The Dutch draft Bodily Material Act is about material, not data. This might lead one to believe there's no overlap. But if you extract data from material, you're doing something with both data and material. That's why I'm discussing my thoughts on the draft act here. Spoiler alert: it's not good.
Subsidy or assignment?
It is not always immediately clear whether there is a subsidy or a commercial assignment. A subsidy is legally defined as: “the claim to financial resources, provided by an administrative body for the purpose of certain activities of the applicant, other than as payment for goods or services supplied to the administrative body.” The latter is important for the distinction between a subsidy and a commercial agreement. For example, if the police purchase bulletproof vests, then it is a commercial contract, because although the police work for the benefit of society, those vests are actually purchased for, and supplied to, the police themselves. This is different when an academic hospital receives government funding to conduct research into a rare disease. Any new treatment developed is intended for patients, not for the government. Moreover, the treatment is not delivered to the government, but only proof that the subsidized activity has actually been carried out. To determine whether we are dealing with a commercial assignment or a subsidy, we must therefore look in particular at what exactly must be delivered and for whom it is intended; is a service or product provided to the grant provider, or is only evidence of the activity provided?
No free choice
Parties may not, or cannot, decide for themselves whether something is a contract or a subsidy. If it falls under the above definition, it is a subsidy, and vice versa. If the above still doesn’t lead to a decision, the court will also consider: (i) is the payment (lower than) the cost price or is there a profit margin, and (ii) who initiated the activity. The underlying idea is that a commercial contractor wants to make a profit and generally doesn’t start work until it’s clear whether someone will pay. The distinction between subsidies and commercial contracts is important for VAT; VAT doesn’t have to be paid on subsidies, which is why opposing parties can argue that something is a subsidy when in fact it isn’t. Also note that the definition of a subsidy doesn’t specify whether there was a call for tenders or a call for tenders. Therefore, a call for tenders (contrary to popular belief) doesn’t mean it’s not a subsidy; one could be mistaken, and moreover, under European law, subsidies are increasingly required to be put out to tender.
The Ministry of Health, Welfare and Sport will soon determine who will become the HDAB; who will be the source of permits for the beneficial reuse of health data. Who can be this, and who cannot? And what will this HDAB be responsible for?
Under the EHDS, work must be performed in a Secure Processing Environment (SPE). Scientists don't receive data, but access it in a SPE that meets the strict technical and security standards established under the EHDS. What does this entail? And will everyone be required to work in such a SPE from now on? Will it become a supercomputer containing all our health data?