Review Reports

Round 1

Reviewer 1 Report

The commented article is of a review character. The Authors have a very good knowledge of literature (however, the latest literature is missing). They skillfully combine the issues of public health with the specific model of the EU functioning, which can be described as multilevel governance. However, it is always based on the principle of subsidiarity in EU activities. The Authors are wrong, however, when stating that the EU may only exercise actions to support, coordinate or complement the action of the Member States in the health policy. The EU also exercises shared competences with Member States in the field of common safety concerns in public health matters for the aspects defined in the Treaty on the functioning of the European Union (article 4.2 (k) TFEU). By presenting HTA and EUnetHTA, they skillfully avoided being entangled in excessive technical details. The article may be a starting point for further scientific discussion. I suggest some changes to the article's internal layout. Parts 3.2. and 4.1. have the same title ("HTA basic considerations"). I propose to remove this repetition, which will improve the clarity of the structure of the text.

Author Response

The paper has been revised according to some comments of the reviewer we thought would bring added value to our article.

We took into consideration the assertion that the EU also exercises shared competences with Member States in the field of common safety concerns in public health matters for the aspects defined in the Treaty and revised our claim in the abstract.

Moreover, starting with the line 504 a new subparagraph (2.4.) was introduced with the title: “The proliferation of the OMC in the health care and its importance for achieving network goals” so that the relevance of the OMC to the health care and networks to be more easily to find.

Also, we have made the necessary revisions given that there were two sections 2.2 (line 235) and also changed the title of parts 3.2. and 4.1. because clearly that was an error. In addition, the title of subparagraph 4.1. has been changed in “EU’s health policy particularization and HTA interaction: developing a network approach”. New literature in regard with OMC was also added as well as some new ideas so that the readers understand better why OMC was chosen by the Commission in this particular field that is pricing & reimbursement of pharmaceuticals.

As well, throughout the paper some changes have been made to some lines or paragraphs, either there was about wording change, either about appropriate quoting as indicated by the editor.

We would like to thank the reviewer for such useful comments.

Reviewer 2 Report

This article provides an interesting angle to operationalize OMC in the development of healthcare policy in Europe, as well as the relevance of OMC and network governance.

However, other being descriptive, one might gather that the relationship between network governance and OMC is not clearly explained and illustrated. How the shift from network governance to OMC is also opaque. In general, the concept of OMC and its relevance to health technology assessment has to be tightly elaborated, in one way or another.

This, on the other hand, has been observed in the final remarks that '...the concept (of network governance) might be directed to certain characteristics accepted by a majority of scholars.' which we don't see novelty and the association of network governance with OMC, then applicable to the development of HTA policy in Europe.  Readers might not be clear why (certain types of) OMC appears to be a very useful tool (as an explanatory variable to explain how governance), and what additional insight (at least some empirical evidence, such as interviews or quote) can lend itself to the literature of network governance.

Counter-intuitive as it can be, what if OMC were not identified, what would happen as a consequence?

 

Author Response

The paper has been revised according to some comments of the reviewer we thought would bring added value to our article.

In order to improve the relation between network governance and OMC in the health care policy field, two concepts that are at the core of our analysis, we have introduced some explanations regarding the context that governs  the EU health policy: visible contradictions that health policy is facing, associated with the hesitation of Member States to transfer power in this area. As such, some additions are visible in lines 31-41, 48-50, 54-55, 59-62.

Furthermore, starting with the line 504 a new subparagraph (2.4.) was introduced with the title: “The proliferation of the OMC in the health care and its importance for achieving network goals” so that the relevance of the OMC to the health care and networks to be more easily to find. Also, we have made some necessary revisions given that there were two sections 2.2 (line 235). In addition, the title of subparagraph 4.1. has been changed in “EU’s health policy particularization and HTA interaction: developing a network approach”. New literature in regard with OMC was also added as well as some new ideas so that the readers understand better why OMC was chosen by the Commission in this particular field that is pricing & reimbursement of pharmaceuticals.

Further, our conclusions were reinforced by adding new assertions based on already existing evidence from other research papers related to  the OMC contribution to this field. We also believe that the results achieved by the EUnetHTA network stands as empirical evidence that in this specific field using OMC has developed uniform approaches that can be further addressed.

As well, throughout the paper some changes have been made to some lines or paragraphs, either there was about wording change, either about appropriate quoting as indicated by the editor.

We would like to thank the reviewer for such useful comments.