The Hungarian Secretary of State for Health recently announced that starting in autumn 2016 a uniform contract template issued by the National Healthcare Services Centre (ÁEEK) must or should be used for clinical trials conducted in Hungary. In theory, the template should be used between the company initiating the clinical trial (sponsor) and the health care institution where the trial is carried out. The template is intended to simplify the contractual procedure and create a more predictable and transparent legal environment thereby enhancing Hungary’s competitiveness in this area. Several sectoral organisations welcome this idea.
Currently, there is no publicly available information regarding the content of the template, however certain preliminary questions may be raised in advance, such as:
- Who will be the parties to the uniform contract template? Will there be just one contract template with the hospital or will there be templates for different contracting parties (e.g. investigators, nurses)? More possibilities would be useful as different contractual setups may require different solutions.
- Will one contract template be sufficient to address different medical approaches, concepts and ideas? Presently, parties are relatively free to determine these within the framework of the laws. It is possible that the template will hinder this freedom.
- Will there be any possibility for the parties to deviate from the content of the template agreement? If yes, to what extent and will it be subject to prior approval? In this respect it should be observed, amongst others, that in many cases similar trials are conducted simultaneously in different countries and it may be vital for the sponsors to ensure a certain level of harmony between them.
- Will the template be balanced for all parties? In order to ensure the anticipated effect, besides providing reasonable terms for the institutions, the template should also consider and reflect the interests of sponsors. The way the authority handles the most sensitive contractual terms, such e.g. indemnity, (limitation of) liability, insurance coverage, will be very important.
The government must consider questions such as these in order to be able to increase the number of clinical trials; an inflexible mandatory document might cause the opposite effect.
In addition to the uniform contract template, the Secretary of State for Health also mentioned a "common" database which would be available to doctors, researchers and patients e.g. to simplify the selection of patients participating in trials. Unfortunately, there is no further information available regarding its exact function, therefore it is uncertain how this database would affect clinical trials carried out in Hungary.
A more predictable environment may attract pharmaceutical companies, although it is still a question whether such new contract template(s) will be able to meet market demands and provide the necessary flexibility.