In this memorandum we will discuss public and private law organized market access. We look at the current practice of assessment and decision-making from different angles.

Market access determined by public law

In the process of market access determined by public law, two different moments are important. The first moment is the market authorization, the legal authorization to market a medicine (EMA), medical device (CE) or food (Food and Consumer Product Safety Authority). Legally valid marketing is in principle governed by European law and regulations, because this refers to the principle of the free market of goods and persons. There should be no obstacles to the free movement of goods and services.

The second moment is reimbursement. It is known that non-reimbursed care has a smaller market than reimbursed care (the so-called insurance effect) and obtaining reimbursement is therefore the aim in most cases. If a producer of a good or service wants reimbursement from or on account of a national health care system – in other words if a third party has to pay the user’s costs – then national law is important. Each country can set requirements from its own social insurance system to guarantee the accessibility and affordability of the system. The Netherlands does the same. We therefore have to deal with the Healthcare Market Regulation Act (WMG) and, in this case, also with the Healthcare Insurance Act (Zvw). The WMG says that it is forbidden to charge for a service in healthcare without a performance description and the Zvw stipulates that a product or service to be reimbursed must meet the package criteria, including compliance with the State of Science and Practice (StWP ).

Public law legislation applies, public law bodies such as the VWA, the Dutch Healthcare Authority (Nza) and the National Healthcare Institute (ZIN) are the actors that determine, implement, decide and monitor. No private party is formally involved in the admission and reimbursement decisions. This is also not possible because the resources that become available for health care are determined directly or indirectly by the government. The budgetary framework for care (BKZ) set by the Ministry of Finance and approved by the Government is leading to this.

State of science and practice

As a starting point for the influx of all medical devices, both innovative devices and the (technical) variants of devices already included in the reimbursed package, the Zvw states that medical devices that meet the package criteria automatically belong to the Zvw package. The effectiveness criterion ‘state of science and practice’ (StWP) is therefore decisive. ZIN have written a great deal about this criterion and its application in recent years, with the final highlight for now being the report Assessment of the state of science and practice, Definitive updated version January 2015.

In the first instance, care providers and health insurers themselves determine whether a medical device – based on the state of science and practice – is proven to be effective and belongs to the basic package. If they cannot reach a mutual agreement, the National Health Care Institute (ZIN) can provide clarity with a position. In addition, ZIN can independently adopt a position on what is covered by the insured care. ZIN requests the parties to provide all available and up-to-date information about research and its application in practice, after which they assess this in the light of the Zvw.

Whether or not a new medical device will become available quickly or not is therefore mainly up to the provider (the manufacturer) or the distributor of the medical device and whether these are able to convince healthcare providers and health insurers that the device complies with the state of science and practice. This means that the aid is proven to be effective (evidence based) based on the best available evidence.

In order to estimate whether a technology will pass through the ZIN of the StWP successfully, it is useful to outline the assessment framework of the ZIN in a nutshell.

To determine the StWP, the ZIN checks whether the treatment policy of a new technology (diagnostics, treatment), given its favorable and unfavorable consequences (side effects, safety), leads to relevant added value for the patient compared to the standard treatment or usual treatment. This is formulated by ZIN as follows: “does the ‘net addition’ of the intervention to be assessed, in comparison with existing care, yield a desired, relevant added value, which is large enough and offers sufficient confidence, in such a way that this addition actually occurs. ? ”. The ZIN describes this as the so-called “relative effectiveness of an intervention”.

The ZIN emphasizes that this assessment is mainly about a comparison: “In order to be able to take a position on the effectiveness of an intervention, we make a comparison. In order to be able to make that comparison, we determine for each intervention to be assessed:

• With which intervention do we compare the intervention to be assessed?
• Which target group is the intervention aimed at?
• Which outcomes do we consider crucial / important and do we include them in the comparison?
• Do we find the outcome of the comparison (the relative effect) large enough (in other words, is the outcome clinically relevant)?

Based on this – and depending on whether we can have sufficient confidence in the outcome of the comparison – we draw a conclusion “.

The standard procedure is that the ZIN follows the principles of evidence-based medicine (EBM) for assessing whether healthcare complies with the StWP. EBM was developed primarily to guide practicing physicians in making clinical decisions about individual patients, but these principles are now finding wider application.

According to the ZIN, the StWP formula indicates that this does not concern two separate criteria (’the state of science’ and ’the state of practice’), each of which must be assessed separately and could potentially give a contradictory result.  The wording indicates that it concerns one integrated legal standard. The ZIN about this: “EBM combines and unites the two elements, science and practice”.

The core of EBM is that the available evidence – which can range from randomized comparative research to practical experience – is systematically searched and selected and weighed and used in a structured way. EBM’s starting point is that high-quality scientific research weighs most heavily in the assessment and ZIN generally considers a randomized controlled trial as evidence of the highest degree (see below), with the note that the ZIN also understands that RCTs necessary or feasible.

Working according to the EBM principles has a number of fixed steps: searching and selecting information, assessing the information found and drawing a conclusion. The evidence according to EBM principles is usually structured on the basis of the so-called PICOT questions, which we describe as follows:

PICOT stands for:

• Patient = the relevant patient population;
• Intervention = the intervention to be assessed;
• Comparison = the intervention with which is compared;
• Outcome = the relevant outcomes / outcome measures;
• Time = minimum required follow-up period.

When assigning levels of evidence according to the methodology for EBM that is widely used in the Netherlands and adapted by the ZIN, a systematic review of at least 2 studies of the A2 level counts as the highest level of evidence (A1 level).

In order to conclude that the care is effective, the ZIN must have at least 1 study of A1 level or 2 studies of A2 level with unambiguous positive results. However, this may be deviated from on account of plausible compelling arguments.

The levels of evidence are:

• A1: systematic review of at least 2 independently conducted studies of A2 level
• A2: randomized double-blind comparative clinical trial of good quality and of sufficient size
• B: comparative study, but not with all characteristics as mentioned under A2 (this also includes case-control study, cohort study)
• C: non-comparative study
• D: expert opinion

According to the ZIN, “appropriate evidence” includes more than just randomized trials. A search by the ZIN for guidance on what is appropriate evidence for specialist medical care has ultimately resulted in an approach based on the integration of clinical conditions, clinical expertise and pathophysiology.

Furthermore, there must be a performance description in order to be able to invoice as a healthcare provider. This is the task of the Nederlandse Zorg Autoriteit/Dutch Healthcare Authority (NZa). Health insurers lay down in contracts with care providers what care is provided, at what quality and at what rate. The NZa helps with this by determining descriptions of the treatments (performances). Maximum rates apply to certain treatments. This means that the rates may be lower but not higher than that maximum. The NZa sets these maximum rates on the basis of periodic cost investigations. Free rates apply in a number of sectors: throughout paramedical care, the majority of medical specialist care and part of general practitioner care. This means that the NZa does not conduct a cost study and does not set a maximum rate for this care. The Minister of Health, Welfare and Sport and the House of Representatives determine for which care sectors free tariffs apply.

Example: Market access for outpatient medical devices determined by private law

In addition to the public law rules for market access, health insurers have introduced two rules based on private law that offer options for whether or not to admit a preparation or product to the reimbursed package for outpatient medical devices prescribed by a medical doctor or GP.

The first rule is that the product, depending of the category (these are incontinence products, ostomy, diabetes care), must be listed in the so-called Z-Index. The Z-Index is a list of medical devices compiled and maintained by an external private organization. This organization takes up the products for a fee and distributes these lists in the market for a fee. This list is the successor to the KNMP Taxe used in the past.

After publication of the list, which is published monthly, a health insurer or the joint health insurers can decide to put a product “not reimbursable”. This mainly happens with products that can be used for wound care. The procedure is unknown in terms of procedure and content and can differ per health insurer.

The second rule or option not to reimburse products or services lies in the contracting policy of a health insurer. Health insurers can select by distributors and by products and services. There are many options for controlling products and services. This can range from exclusions to preferences, from daily prices to maximum prices, from 1 distributor to many distributors, etc. Health insurers contract with distributors and not manufacturers. Manufacturers must do business with distributors.

Daily practice of health insurer and legal action.

In conclusion, we can state that a medical device that wants to be reimbursed from the Dutch healthcare system must in certain cases comply with the rules of the VWA (market authorization) or have CE, the Nza (performance description) and the ZIN (positive interpretation / position on the StWP). If these matters are met, the insured person has a claim and the health insurer a duty of care to be able to cash in on the claim. However, as we have seen above, the claim is a generic claim. The exact interpretation of which product or service is involved is an exercise for the health insurer.

The following is of great importance in this regard. A lawsuit that clarifies where the limits of the powers lie. The judgment clearly indicates the responsibilities of the parties and damage that may result from unlawful acts.

Authority: District Court of Gelderland

Date of judgment: 11/15/2013 Case number 251823

Areas of Law: Civil Law

Special features: Interim injunction

Content indication Interim proceedings

Ask whether a preference policy with regard to diet preparations (drinking feeds) in healthcare (purchasing) contracts for 2014 between health insurers and suppliers is unlawful towards patients and dieticians. The Preliminary Relief Judge considered that an obligation in the health care contracts to deliver a preferred product selected by the health insurers in at least 75% of the cases, in fact constitutes or may result in a limitation of the claim that insured persons have to the provision or reimbursement of dietary preparations. This is in violation of the Health Insurance Act and the regulations based on it, which, unlike with regard to medicines, do not provide for the possibility of pursuing a preference policy with regard to dietary preparations. The reimbursements set by health insurers for concentrated drinking feeds that fall outside the preference policy, with discount percentages of 48 to 56% on the pharmacy purchase price (AIP), are arbitrary with regard to the manufacturer, taking into account all circumstances, including the risk of significant damage for the manufacturer, are careless and unlawful towards the manufacturer. The Preliminary Relief Judge forbids health insurers from continuing to implement a number of parts of the healthcare contracts already concluded or from entering into contracts for those parts. The manufacturer’s requirement to order health insurers to include certain reimbursements in contracts is rejected. In principle, health insurers are free to determine those reimbursements and to agree with the delivery companies, provided that this is not done in a manner that is unlawful towards the manufacturer.

Daily practice ZIN

In practice, we see that if the ZIN decides to provide an interpretation or to determine a position, the ZIN approaches market parties such as scientific associations of practitioners and patient organizations to request an opinion. This is not a legal obligation, but a purely pragmatic approach. Because if it turns out that a scientific association has no confidence in an innovation in healthcare, the ZIN will save itself the trouble of treating it. After all, the handling of such a file requires the necessary care (an incorrect assessment results in damage that can be recovered from the assessor) and time and ZIN has to make choices in view of the enormous amount of innovations that want to enter the package. Another option is that the ZIN refers the treatment to one or all health insurers, which have also been authorized to do so since 2015. It should be borne in mind here that there is a latent tension between market authorization (free movement of goods and services, European regulations) and reimbursement (access and retention of the healthcare system, Dutch regulations). In this context, the international coordination of files by assessing bodies must therefore be seen. As a result of the Decker and Kohl judgments made by the European Court, the E103 rights can also play a role.

In the procedure, the ZIN also provides for consultation of the Scientific Advisory Council (WAR) and the Advisory Committee on the Package (ACP).

The Scientific Advisory Council is an integrated assessment committee that provides scientific advice in the field of package management tasks and in the field of quality. In addition, there are separate working committees for specific areas of attention. The WAR consists of various experts, including doctors, scientists, researchers and policy advisers within healthcare.

The Package Advisory Committee advises the Board of Directors (EB) of het Zin on proposed package recommendations. It tests these recommendations against the 4 package criteria (effectiveness, cost-effectiveness, necessity and feasibility) and assesses whether the outcomes are socially desirable. In doing so, she looks at both the interests of the patients who are eligible for reimbursement for a particular intervention. As well as the interests of patients with other conditions (who also want the treatment of their condition to be reimbursed) and the interests of all premium payers. The committee does this based on the principle that basic insurance should provide maximum health benefits for the entire population.

In order to make a statement about this, the committee uses so-called reference values ​​for cost-effectiveness. These reference values ​​should be understood as the maximum amounts that we as a society want to invest in a treatment per life year gained. If we go above that, there is a displacement of other care. That means that for the same amount, more health gains can be obtained by spending it on other treatments. So there must be very good reasons to accept a cost-effectiveness equal to or even more than the reference value.

The input of these parties ensures that there are careful considerations and that the various social interests are included in the decision-making process.

Practitioners

Until now, we have not yet seen the position of the practitioners. Other than that practitioners, acting individually or jointly, can have an opinion as to whether a product or service complies with the StWP. However, this opinion is noncommittal because it is not embedded in any way whatsoever in public law regulations or private law regulations. There is no legitimacy other than the valuation of scientific knowledge as such, without any legal consequence.

The role of a scientific association may well be the drawing up of treatment guidelines, whereby as far as the knowledge reaches, there is always a generic approach to products, certainly if there are medical technological aids with (technical) variants. This does not take place on the basis of legal obligations, but is purely the initiative of the professional group and therefore private law in nature and only has effect for those who adopt the advice as expressed in the guideline. The risk of liability due to potential market barriers must be taken here, but in practice this does not yet occur because, as stated, it is a generic approach and not specifically named products.

Treatment guidelines can be national (NHG standards for example), regional (collaborating hospitals) or local (formularies, etc.). These treatment guidelines are of a private law nature because they are not based on legal obligations or are drawn up within the mandate of a public law organization such as the ZIN or the Nza. It must always be borne in mind that conflict with public law regulations can lead to problems, which conflict can in turn entail liability for compensation. The tasks and powers of the ZIN, Nza or VWA cannot be taken over without explicit consent and mandate based on government decisions.

Ron de Graaff LL.M