The Pharma Legal Handbook: Belgium

On 16 April 2020, a new Act was adopted by the Belgian parliament to increase the transparency of managed entry agreements (‘MEA’) concluded between pharmaceutical companies and the National Institute for Health and Disability Insurance (‘NIHDI’). MEAs stipulate confidential compensation mechanisms for the Belgian government regarding the publicly-listed price and reimbursement basis of the medicine(s) concerned. The Act provides that if the Belgian parliament’s Chamber of Representatives orders a management audit, then the Court of Audit is granted full access to the MEAs, including their confidential parts.

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On 8 April 2020, the Belgian federal agency for medicines and health products (‘FAMHP’) adopted a consolidated version of its decision (the ‘Decision’) taking the following urgent measures for certain listed medicines (and raw materials) to avoid medicine shortages during the SARS-CoV-2 pandemic:

 

1. Wholesalers, full-line wholesalers and manufacturers are obliged to limit their sales to full-line wholesalers and pharmacies for the products concerned to amounts that correspond to the sales for the same period of the previous year increased by a maximum of 50%.
2. Export to a different European Economic Area (‘EEA’) member state is permitted only if the medicine or raw material is intended for delivery or administration in that member state, and a prior notification is given to the FAMHP.
3. Export to countries outside the EEA is permitted only if a prior notification is sent to the FAMHP and if the FAMHP does not object within three business days. Such refusal is possible if the volumes available are insufficient to meet the needs of patients in Belgium for the following four weeks.
4. For possible reallocation purposes, hospitals and pharmacies should notify the FAMHP if they have any stock exceeding the sales volume for the same period of the previous year increased by a maximum of 50%.

 

The above measures apply for the entire month of April 2020 and are renewable each following month. This blog post discusses the background and measures in more detail, as well as their legality under EU law.

 

Background to the measures

The FAMHP adopted and published a first version of its Decision on 1 April 2020, and provided further details about the measures in an update on its website on 2 April 2020. The FAMHP has now adopted and published a modified and consolidated version on 8 April 2020, again with further details about the measures in a new update on its website.

The FAMHP has explained in its Decision that the speed of the SARS-CoV-2 virus’ transmissibility into a pandemic was not foreseeable, and that a sudden peak in the number of contaminations has risked overloading the health care system with serious consequences for public health. Given the unequal stock distribution between different actors and the sudden increase in demand for certain medicines used in the treatment of COVID-19 patients, certain medicines or raw materials are no longer available at some pharmacies, hospitals and wholesalers, or risk becoming unavailable in the near future in the absence of urgent measures.

 

Types of therapeutically essential medicines

The FAMHP’s measures relate to medicines that the FAMHP considers as ‘therapeutically essential’ medicines. A first category concerns potential or promising treatments of COVID-19 as discussed in the interim clinical guidance for COVID-19 patients. A second category concerns medicines that are applied for the treatment of hospitalised COVID-19 patients that are not antivirals but provide the necessary care and treatment of complications, such as antibiotics, benzodiazepines and curarizing agents.

The listed medicines are considered as critical and essential medicines because there are no complete alternatives available. Article 1 of the Decision subdivides these medicines into: medicines that consist of a single active substance (Annex I), medicines with more than one active substance (Annex II), and raw materials (Annex III). Almost all of the medicines are for intravenous use.

 

First measure: supply quota for wholesalers, full-line wholesalers and manufacturers

Article 2 of the Decision orders wholesalers, full-line wholesalers and manufacturers to limit their sales of medicines and raw materials to an amount that corresponds with their sales for the same period of the previous year increased up to a maximum of 50%. This applies for each medicine or raw material, regardless of the dosage, composition or packaging of the medicine. The sales referred to are those to full-line wholesalers and pharmacies.

The entities above can supply larger quantities provided (i) that this does not jeopardise the supply to other full-line wholesalers, pharmacies or hospitals, and (ii) there is prior notification to the FAMHP. Additionally, the FAMHP may order wholesalers to supply in accordance with a specific supply ratio or other specific instructions.

 

Second measure: conditional supply to recipients outside Belgium

Article 3 of the Decision subjects the supply to entities established outside of Belgium to additional conditions, in respect of which two different regimens apply:

1.  Supply to a different EEA member state is permitted provided that the medicine or raw material is intended for delivery or administration in that member state, and if a prior notification is sent to coronashortages@fagg-afmps.be with the following subject line: “Notificatie Export EER / Notification d’exportation EEE – [Name of MA holder] – [Name of the medicine]”.
2. Supply outside the EEA is permitted if a prior notification is sent to coronashortages@fagg-afmps.be with the following subject line: “Notificatie Export BUITEN EER / Notification d’exportation HORS EEE – [Name of MA holder] – [Name of the medicine]”, and if the FAMHP does not object within three business days (by email). Such refusal is possible in the event of an acute or imminent shortage of the medicinal products or raw materials in question, meaning that the volumes available are insufficient to meet the needs of patients in Belgium for the following four weeks. This takes into account the availability of an equivalent therapeutic alternative, as well as the needs in the framework of the treatment of COVID-19 patients, based on present epidemiological models and taking into account standard doses.

The notifications should mention the medicines/raw materials concerned, quantities and country of destination. Templates (NL, FR, EN) for the above notifications are available on the website of the FAMHP, and, after completion, should be named pursuant to the guidance on the FAMHP’s website.

The FAMHP can grant exceptions to the above rules. The supply of the FPS Health, Food Chain Safety and Environment, in the framework of building up strategic stocks, is permitted without prior notification.

Regarding the two above exceptions, in line with Article 126 of the Agreement on the withdrawal of the UK from the EU, the “EEA” includes the UK until 31 December 2020. Additionally, although Switzerland is not part of the EEA, it is questionable whether the FAMHP intended to subject export to Switzerland to the stricter regime under point 2 above requiring an exception to be granted as it constitutes an EFTA country and a very important trade partner of the EU.

 

Third measure: notification and possible reallocation of large stock

Finally, Article 4 of the Decision orders hospitals to notify the FAMHP of stocks of medicines (or raw materials for compounding) that exceed a volume corresponding to the sales for the same period of the previous year increased by a maximum of 50%. This notification serves to identify where stock reallocation may be necessary.

 

Analysis under EU law of the conditional export within the EEA

The conditional export within the EEA of Article 3 constitutes a possible restriction on the fundamental free movement of goods principle, under which all goods (including medicines) must be able to move freely and without any hindrance within the EU/EEA. This principle is one of the cornerstones of the EU’s internal market but is not absolute. In specific circumstances, restrictions or even prohibitions are acceptable under Article 36 TFEU when serving important purposes, such as the protection of the environment or human health and if they respect the principle of proportionality and necessity (for more details on this matter, please see our coronavirus Q&A).

In its coordinated economic response, the Commission has addressed the issue of several national export restrictions (on protective gear and medicines) and has emphasized in this regard that “Any national restrictive measure taken under Article 36 TFEU to protect health and life of humans must be justified, i.e. suitable, necessary and proportionate to such objectives by ensuring an adequate supply to the relevant persons while preventing any occurrence or aggravation of shortages of goods, considered as essential, such as personal protective equipment, medical devices or medicinal products. Any planned national measure restricting access to medical and protective equipment must be notified to the Commission, which is to inform the other Member States thereof”.

In Annex 2 of its communication, the Commission has added that “Measures regulating the concerned markets with adequate mechanisms to channel essential goods where they are needed the most both within the Member States and to qualified buyers in other Member States, can be a positive contribution to the overall coordinated European approach to help saving lives”.

The same principles are confirmed in the very recent European Commission’s Guidelines of 8 April 2020 on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak. The Commission recalls that “Member States are expected to protect public health in a spirit of European solidarity. In order to achieve this objective, it is critically important that Member States lift export bans on medicines within the internal market. Whilst it is understandable that countries wish to ensure the availability of essential medicines nationally, export bans are detrimental to the availability of medicines for European patients even when they are legally justifiable. Measures leading to requisitioning of medicines, intermediates or APIs, or their production, should not be considered as an option. These measures, especially as far as they are applied to APIs or intermediates, endanger supply since they lead to a slowdown in industry output”.

It is clear that the conditional supply within the EEA is a restrictive measure that “must be notified to the Commission”. However, in the current situation, this measure seems at first sight justified and in compliance with the European standard. The aim seems to be in line with the European Commission’s main priority to “channel essential goods where they are needed the most within the Member States”. Nevertheless, it is important that the notification procedure before FAMHP is used only as a surveillance mechanism and not to indirectly impose an export ban (or other export restrictions).

 

Analysis under EU law of the restriction on supply outside the EEA

Article 1 of Regulation 2015/479 on common rules for exports states that export to non-EU countries “shall not be subject to any quantitative restriction, with the exception of those restrictions which are applied in conformity with this Regulation.” In principle, a member state should send a request to the European Commission, and the latter should decide, within 5 working days, to impose an export ban at EU level in order to prevent a shortage of essential products.

Article 10 of Regulation 2015/479 permits Belgium to adopt quantitative restrictions on exports if these are justified on the grounds of protection of life and human health. Against the background of Article 1, this presumably requires that urgency makes it impossible for a member state to consult with the European Commission. Moreover, such an export ban requires compliance with the overarching principles of proportionality and international solidarity, so that a request for the export of a product outside the EEA can only be refused when strictly necessary in light of immediate shortages for that product.

The modification of the Decision of 8 April 2020, no longer requiring to obtain approval for exports to the EEA but only to proceed to a notification, is clearly more in line with the principles of proportionality and international solidarity. However, if the FAMHP nevertheless decides to oppose a certain export within three business days, this export ban will still have to be very well substantiated.

 

Conclusive remark

The Decision’s measures are far-reaching and therefore strictly limited in time. They apply as from the first until the end of April 2020 and are renewable each month. They are part of, and contribute to, a worldwide reaction to the COVID-19 pandemic in which countries are reverting to ‘national reflexes’. Such ‘national reflexes’ are only permitted if they meet the solidarity principles of EU and international law and the fundamental principle of free movement of goods.

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With national governments scrambling to take measures in order to counter the Covid-19 pandemic, we are again confronted with the fact that a EU common policy in the healthcare field is quasi inexistent. This is equally so in respect of the pricing and reimbursement of medicines.

 

While the so-called Transparency Directive 89/105/EEC provides for a limited harmonization of pricing & reimbursement procedures, one however cannot deny a growing tendency of national governments to look beyond their national borders and even to collaborate in this field, as appears e.g. from the Beneluxa initiative. One of the more striking developments is the instauration of price reference systems in various countries, whereby the level of reimbursement and pricing is made dependent upon the prices applied in selected third countries. As will be illustrated by the present blog, the reverse side of such development is the necessity for national pricing authorities to take into account the fact that their policy might have unintended consequences due to the cross-border effect thereof. If not, national measures risk to “backfire” as seems to have happened with the most recent attempt of the Belgian authorities at further reducing the prices of medicines.

 

Introduction

The reimbursement of medicines in Belgium is never a question of straightforward mathematics. Over the years, the legislator has introduced a variety of measures allowing for reductions of, and clawbacks on the amounts spent by the Social Security Institute (INAMI/RIZIV) on the provision of medicinal products to Belgian patients. Within this context, any attempt to realize budgetary economies entails further additions to an expanding list of provisions and arrangements incorporated in various increasingly complex legislative instruments. In a recent advice (66.872/2), the Council of State has even qualified a recent legislative proposal to this end as “illegible”. This draft Act was tabled by the government on 11 February 2020 and purported to introduce further economies in the reimbursement of medicinal products in the framework of the 2020 healthcare budget, already with effect from 1 April 2020. Quite unexpectedly, the legislative approval process has now (temporarily?) been stopped, allegedly in view of the ‘more urgent matters’ imposed on the federal parliament by the Covid-19 pandemic. The purpose of this blog is not to investigate the reasons behind this new development but to highlight the unintended consequences which arise when pre-existing arrangements are modified on too short notice.

 

The Draft Act

According to the Explanatory Memorandum of the draft Act, the purpose was to realise multiple economies, in particular by a further deepening of the “old drugs cliff” (the mandatory price decrease imposed on reimbursed medicines after 12 respectively 15 years of reimbursement status) and of the “bio cliff” (a similar measure for biological medicines imposed after 18 years of reimbursement status or once competing biosimilars are accepted for reimbursement).

Additionally, the draft Act also provided for the disappearance of the so-called “safety margin”. This is a margin which can added to the reimbursed price of “off-patent” originator medicines when these are “clustered” with their competing generic versions. Under the present rule, when the originator is confronted with the market launch of a reimbursed generic version, the so-called reimbursement basis of its product will be reduced to that of the generic version. However, the choice is left to the originator either to (i) withdraw the reimbursement of his product, (ii) accept the same reimbursement level as the generic, or (iii) apply a safety margin of 25 % with a maximum of 5 EUR. Many originator products have over the years opted for the application of such safety margin. As the safety margin is paid by the patient, its abolishment was viewed as a significant measure in favor of patients. According to the draft Act, the latter option would be abolished with effect on 1 April 2020 and there would be a “regularization” (i.e. equalization) of the price at the level of the reimbursement basis.

 

Impact on Reference Pricing in Other Countries

The disappearance of the safety margin in conjunction with the other price reductions imposed by the draft Act, would lead to a substantial mandatory price decrease for many branded medicines. Belgium being a reference country for several other European countries, a price decrease in our country would however necessarily lead to a domino effect on the prices applicable in those countries and thus to a potential indirect loss far more important than the direct loss resulting from the price reduction imposed at the Belgian level. A first unintended consequence would therefore be that in many instances originator companies would be forced to take the product from the Belgian market.

However, the only option left to companies to do so was to request the withdrawal of the reimbursement status, which under normal circumstances takes effect only after one year. It is possible to request such withdrawal on an urgent basis for social, economic or therapeutic reasons, but, even if accepted by the Minister of Social Affairs, such procedure still takes several months. A second unintended consequence was therefore that, with the mandatory price decrease applying in Belgium with effect on 1 April 2020, the nefarious transnational effect of this price decrease could thus not be averted.

 

The Need for Appropriate Transition Measures

The above situation highlights the need for adequate transition measures in draft laws such as the above. In the absence thereof, there are also legal arguments that support the possibility of immediate withdrawal. Originator firms which had initially been given the choice to withdraw the reimbursement status of their product, align their price with generic competition, or apply a safety margin, would now be deprived of this choice on very short notice and become subjected to a regime which they elected not to be subjected to.

While a public authority is obviously entitled to opt for a change of policy, a precipitous change without objective or reasonable justification for the lack of transitory measure will be questionable in view of the principles of legal security and confidence on which addressees of legal provisions should be entitled to rely. The Belgian Constitutional Court has already ruled that the prohibition of discrimination enshrined in articles 10 and 11 of the Constitution is violated “if the lack of a transitory provision leads to a difference in treatment for which there is no reasonable justification or if the principle of confidence is violated excessively” (judgment nr. 170/2014).

The absence of transitory measure or (renewed) option for the addressees of the price reductions somehow puts the latter in a less favorable position than those who effectively retain this choice because their products have not (yet) been clustered.

 

Conclusion

As the ongoing Covid-19 crisis shows, the world or at least Europe is the proverbial village, where acts have consequences, not only at home but also with one’s neighbours. The draft Act did not just force many originators to choose between withdrawing their product from reimbursement in Belgium or potentially subjecting their affiliates in other European countries to further price decreases going beyond the benefit of maintaining reimbursement in Belgium, it also left these companies stranded between both chairs. By doing so, had it not been for a postponement of the draft Act, it risked backfiring at the Belgian government.

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In its ruling of 30 January 2020, the Court of Justice of the European Union (‘CJEU’) has clarified for the first time the criteria governing whether a reverse payment settlement agreement concerning a dispute between the holder of a pharmaceutical patent (‘originator’) and a manufacturer of generic medicines (‘generic’) is contrary to EU competition law. In particular, the Court has provided further guidance on whether and when: (i) originators and generics should be considered as ‘potential competitors’, (ii) a patent settlement between an originator and any generic(s) could be a restriction of competition ‘by object’, and, if not, (iii) ‘by effect’, (iv) generic products are to be considered as part of the relevant product market, and (v) such patent settlement agreements could be an abuse of dominance. The ruling confirms once again that reverse payment settlement agreements risk being contrary to EU competition law.

 

Background of the case

The case has concerned the prescription-only anti-depressant medicine paroxetine, marketed in the UK as Seroxat® by GSK. Pending court proceedings between GSK and certain generics regarding a GSK patent for a process of producing a form of paroxetine, the parties concluded reverse payment patent settlement agreements. Under those agreements, the generics committed to refraining from entering the market with their own generic medicines for the term of the agreement, and in return GSK made payments to the generics and allowed the generics to distribute paroxetine produced by GSK.

On 12 February 2016, the UK’s Competition and Markets Authority issued a decision finding that those settlement agreements were a restriction of competition by GSK and the generics, and also constituted an abuse of dominance on the part of GSK. Following an appeal, the Competition Appeal Tribunal handed down its judgment on 8 March 2018 and, by order of 17 March 2018, requested a preliminary ruling from the CJEU for further guidance on the questions and aspects set out in the introduction above and discussed in further detail below.

 

Originators and generics as potential competitors

The CJEU has first reminded that for horizontal cooperation agreements to be subject to the prohibition of Article 101(1) TFEU (the prohibition on anticompetitive restrictive agreements), the coordination must involve competitors or potential competitors. According to the CJEU, generics who are not yet present in a market are potential competitors of originators if there is the real and concrete likelihood that such a generic could join that market and compete with undertakings already present in that market. That is the case if two conditions are met:

1. The generic has a firm intention and inherent ability of entering the market of a medicine containing an active ingredient that is in the public domain (even when there are process patents held by the originator company). This is seen when the generic has taken sufficient preparatory steps to enable entering the market within such a period of time as would impose competitive pressure on the originator. Those steps could include measures for obtaining the required marketing authorisations, the building-up of sufficient stock, taking the legal steps to challenge the process patents held by the originator company etc.

That firm intention and inherent ability to enter the market can also be confirmed by additional indications, like the originator’s intention to make transfers of value to a generic company in exchange for the postponement of the latter’s market entry, even though the former claims that the latter is infringing one or more of its process patents. The greater the transfer of value, the stronger the indication.

2. The market entry of such a generic company does not meet insurmountable barriers to entry. The existence of a patent that protects the manufacturing process of an active ingredient that is in the public domain cannot, as such, be regarded as an insurmountable barrier. This position is not affected by (i) the presumption of validity of a process patent held by the originator, (ii) the uncertain outcome of the validity dispute of that patent, and (iii) the existence of injunctions granted by a national court in which the generic companies are on an interim basis prohibited from selling the generic medicines.

If these conditions are met, then an originator and a generic, which are not yet present in the market of the medicine at issue, can be considered as potential competitors.

 

Restriction by object if the reverse payment from an originator to a generic has no explanation other than the commercial interest of both parties not to engage in competition on the merits

The CJEU further had to assess whether pay-for-delay settlement agreements constitute agreements that have as their object the prevention, restriction or distortion of competition. The qualification of agreements as ‘restrictive by object’ means that they are, by their very nature, considered as harmful to competition, as a result of which it is not necessary to assess their effects.

According to the CJEU, a patent settlement could constitute such a restriction of competition by object when it can be regarded as an agreement bringing to an end entirely fictitious disputes, which it found was not the case here. The fact that a patent settlement involves transfers of value, whether pecuniary or non-pecuniary, is in itself not sufficient ground to classify it as a restriction by object, since those transfers of value may be justified.

However, a patent settlement is restrictive by object when the transfers of value provided for by the settlement agreement cannot have any explanation other than both parties’ commercial interest not to engage in competition on the merits. For that analysis, it should be assessed whether (i) there is a ‘net gain’ for the generic company taking into consideration all the transfers of value made between the originator and the generic, (ii) there are proven and legitimate justifications for that net gain, and (iii) the net gain is sufficiently large to convince the generic.

Pro-competitive effects must also be taken into consideration in assessing whether such an agreement constitutes a restriction by object, provided that they are demonstrated, relevant, specifically related to the agreement and sufficiently significant. In the case at hand, the CJEU hinted that alleged pro-competitive effects (the slight price reduction resulting from limited volumes supplied by GSK to the generic companies), were not only minimal but probably uncertain.

 

Restriction by effect does not presuppose an assessment of the likelihood of success in patent invalidity proceedings, or the probability of less restrictive settlement agreements

If the referring Court would decide that the patent settlements do not constitute a restriction by object, it should assess whether these settlements restrict competition by their effects. To establish the existence of appreciable potential or real effects on competition, the CJEU stated that no determination is required that the generic would probably have been successful in the patent proceedings, or that the parties to that agreement would probably have concluded a less restrictive settlement agreement. These are only some factors among many that arise under counterfactual analysis to determine how the market would probably operate and be structured if the agreement were not concluded. In any event, the restrictive effects must be sufficiently appreciable.

 

Market definition: generic products are relevant when the generics are in a position to enter the market with sufficient strength to constitute a serious counterbalance to the originator

For the product market, the CJEU referred to the general principle of a sufficient degree of interchangeability between the originator and generic medicines. The CJEU first clarified that the interchangeability of products is naturally dynamic. A new supply of products (e.g. generic medicines containing the same active ingredient) could alter the conception of the products considered interchangeable with a product and could justify a new definition of the parameters of the relevant market (e.g. exclusively medicines containing that active ingredient).

Then turning to the question of when there is a sufficient degree of interchangeability between the originator and generic medicines, the CJEU stated that the generic manufacturers should be in a position to enter the market within a short period with sufficient strength to constitute a serious counterbalance to the originator. This is the case where, in the case of an active ingredient in the public domain, those generic companies have formed an effective strategy for market entry, taken the necessary steps to enter the market (e.g. MA application), or concluded supply contracts with third-party distributors.

 

Abuse of dominance can result from the cumulative effects from parallel restrictive agreements that were liable to strengthen the originator’s dominant position

On the abuse of such a dominant position, the CJEU held that a contract-oriented strategy of an originator holding a dominant position in a market may be penalised not only under Article 101 TFEU by reason of each agreement taken individually (restrictive agreements) but also under Article 102 TFEU (abuse of dominance) for the possible additional damage that strategy might cause to the competitive structure of a market. This requires that that strategy has the capacity to restrict competition and, in particular, to have exclusionary effects going beyond the specific anticompetitive effects of each of the settlement agreements individually.

 

Concluding remark

On the eve of Brexit, the CJEU has seized the opportunity of a preliminary ruling reference to determine the criteria governing whether and when a settlement agreement concerning a dispute between an originator and generic(s) is contrary to EU competition law. The judgment confirms once again that reverse payment settlement agreements risk contravening EU competition law. When entering into such agreements to overcome the inherent uncertainties of patent proceedings, originators and generics should ensure compliance with the CJEU ruling.

Given the facts underlying the case and the CJEU’s reference to medicines containing an active ingredient that is in the public domain and (a) process patent(s) held by the originator, lack of clarity still exists about whether the CJEU’s judgment also applies to reverse payment settlement agreements relating to product patents.

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On 3 February 2020 the Act of 20 December 2019 amending various legal provisions concerning shortages of medicinal products was published in the Official Gazette. Except for Articles 2 and 4, which entered into force on 31 January 2020, the act’s provisions entered into force on 13 February 2020. In our view, the new legislation does not prevent pharmaceutical companies from applying quotas, provided that they do not affect the public service obligation of wholesaler-distributors (also known as full-line wholesalers. In addition, we also consider that the act arguably imposes no general obligation on pharmaceutical companies to supply retail pharmacies directly. Several of the act’s provisions are to be implemented by royal decrees which are not yet available.

 

Overview

The new act follows a previous attempt by the legislature to address medicinal product shortages, which was annulled by the Constitutional Court. The act amends the Medicines Act of 25 March 1964 and the Health Insurance Act of 14 July 1994.

Wholesalers should supply medicinal products within three working days to:

• full-line wholesalers to the extent that it concerns a delivery within the framework of their public service obligation; and
• pharmacists (Article 4).

A royal decree will implement this obligation and its control mechanism.

The interruption of the supply to a full-line wholesaler or pharmacist or the lack of a complete supply of the amounts requested within the framework of the full-line wholesaler’s so-called ‘public service obligation’ are now considered a ‘temporary shortage’ (Article 2(2)). Full-line wholesalers must:

guarantee permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very short time over the whole of the area in question.

In the event of a temporary shortage, the marketing authorisation holder (MAH) must notify the Federal Agency for Medicines and Health Products (FAMHP) of the exact reason for the shortage. Failure to do so is considered a lack of notification (Article 2(1)).

In addition, a temporary export ban can be applied to medicinal products for which a shortage is notified or established (Article 3), and the MAH will be required to compensate any additional costs relating to the unavailability of a medicinal product (Article 6). A royal decree will implement the procedure and conditions for both provisions.

If there is a medicinal product shortage, as reported to and published on the FAMHP’s website, pharmacists may deliver a substitute medicinal product with the same active substance or combination of active ingredients, the same strength, the same method of administration and the same frequency of administration, provided that the FAMHP’s guidelines are complied with and the healthcare practitioner has made no therapeutic objection (Article 7). A royal decree will further supplement this article.

Finally, if the medicinal product continues to be unavailable beyond the first day of the twelfth month following the start of the unavailability, it will no longer be reimbursed (Article 5).

 

Impact on pharmaceutical companies active in Belgium

Can pharmaceutical companies continue to use quotas?

The explanatory memorandum of the new act’s first draft referred to quotas of pharmaceutical companies per medicinal product per country as one of the causes of shortages. Several legal provisions of that draft act directly or indirectly referred to tackling such quotas in an attempt to remedy shortages.

The adopted legal provisions no longer contain such references, and it is our view that a quota system does not necessarily violate the act. Rrather, a pharmaceutical supplier should consider whether or not a full-line wholesaler’s order is part of its public service obligation. The pharmaceutical supplier should avoid preventing full-line wholesalers from fulfilling such an obligation, but no more than that. It is not required to supply a full-line wholesaler with products that are intended for export or to supply wholesalers that have no public service obligation.

Should pharmaceutical companies supply pharmacists directly?

The new act stipulates that wholesalers must deliver their medicinal products within three working days not only to full-line wholesalers, but also to pharmacists. However, the Belgian supply chain is based on delivery to full-line wholesalers, which in turn supply pharmacists. Does the new act now oblige all wholesalers to deliver directly to all pharmacists? Arguably, it does not.

The same ‘obligation’ was already stated in the Medicines Royal Decree of 14 December 2006. In fact, the explanatory memorandum of the act states that the purpose of this provision is to enshrine in the Medicines Act the obligations that already exist under that royal decree, so not much appears to have been changed. A general obligation to deliver directly to pharmacists would also impose a huge burden on pharmaceutical companies, disregard the specific cascade system and obviate the need and position of wholesaler-distributors. It would be irrelevant for dealing with shortages, which remains the aim of the new act. The explanatory memorandum confirms the exceptional nature of such direct supply and states that it:

goes without saying that, in cases of urgency, companies can supply directly to the pharmacist, without having to go through the wholesaler (distributors) channel. However, it is not the intention to supply publicly accessible pharmacies on a daily basis.

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The key facts about regulatory reforms in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.

 

1. Are there proposals for reform or significant change to the healthcare system?

As of recently, attempts have been made to remedy the unavailability of medicines on the Belgian market. The Act of 7 April 2019 on the unavailability of medicines introduced two measures in this regard: firstly, certain wholesalers (full-line wholesalers, entrusted with a public service obligation) were prohibited from exporting medicines. Secondly, the modalities and enforcement of the already existing delivery obligation for pharmaceutical companies, regular wholesalers and parallel importers to full-line wholesalers was enhanced. The Act entered into force on 18 May 2019.

After suspending the provision of the Act of 7 April 2019 on the export prohibition in a decision of 18 July 2019, the Belgian Constitutional Court recently annulled this prohibition by decision of 17 October 2019.

Meanwhile another bill has been introduced in Parliament on 28 August 2019, proposing different measures to take action against the unavailability of medicines in Belgium.

 

2. When are they likely to come into force?

Please refer to Question 1 above.

 

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Keen to learn more about patents & trademarks in Belgium? Read on! Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.

 

1. What are the basic requirements to obtain patent and trademark protection?

The Belgian legal framework governing patents and trademarks is enshrined in Book XI of the Code of Economic Law (CEL). A specific framework for Benelux trademarks is provided by the Benelux Treaty on Intellectual Property (BTIP).

The basic requirements to obtain patent protection are the requirement of novelty, inventive step and industrial applicability.

In order to obtain trademark protection, the registration of the sign is required. After that, the competent authority will proceed to the effective registration of the sign if it finds no absolute grounds for refusal and no opposition has been filed by a third party.

 

2. What agencies or bodies regulate patents and trademarks?

The Belgian Office for Intellectual Property (Dienst voor de Intellectuele Eigendom or Office Belge de la Propriété Intellectuelle) is responsible for delivering and managing Belgian titles of intellectual property. In particular, it delivers itself Belgian patents (limited territorially to the Belgium) and accepts applications for both Belgian and European patents. There is also the possibility of filing an “international” application through the Patent Cooperation Treaty (PCT), leading to a bundle of national rights.

Trademarks can be obtained through either the Benelux Office for Intellectual Property (BOIP, granting a trademark limited territorially to the Benelux) or the European Union Intellectual Property Office (EUIPO, granting a trademark limited territorially to the European Union). There is also the “international” registration through the World Intellectual Property Organization (WIPO), which allows the filing of one application in order to obtain trademark protection in the territories indicated by the applicant. WIPO sends the application to the various national trademark offices of the chosen countries, after which the application is subject to the normal granting procedure of each territory.

 

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

Can be protected by a Belgian patent: any invention, for instance products, substances and processes, that are new, industrially applicable and involve an inventive step. This also also includes:

• products consisting of or containing biological material;
• methods for obtaining, editing or using biological material;
• biological material that is isolated or obtained from its natural environment using a technical method provided it is already present in nature;
• inventions pertaining to plants or animals provided that executing such an invention is not technically limited to a certain plant or animal variety.

Cannot be protected by a Belgian patent:

• discoveries, scientific theories and mathematical methods;
• aesthetic creations;
• schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers;
• presentations of information;
• plant and animal varieties and methods of an essentially biological nature for the production of plants and animals, as well as plants and animals exclusively obtained through such methods including the parts of plants and animals that constitute propagating material. This does not include inventions pertaining to a microbiological or other technical method or a product obtained by means of such a method;
• inventions the commercial exploitation of which would be contrary to the “ordre public” or morality including the protection of the life and health of man, animals or plants or the avoidance of grave damage to the environment, knowing that such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation;

The following are in particular deemed to be non-patentable by virtue of the above:

1. methods for cloning people, ie any method including techniques for dividing embryos in order to create a human that possesses the same genetic information in the cell nucleus as another living or deceased human being;
2. methods for modifying the germinal genetic identity of man;
3. use of human embryos for industrial or commercial purposes;
4. methods for modifying the genetic identity of animals that are liable to make these animals suffer without considerable medical use for man or animal, as well as the animals obtained from such methods;

• the human body in the various stages of its formation and development, as well as the mere discovery of parts thereof including a sequence or partial sequence of a gene. This does not include parts of the human body that were isolated or otherwise obtained through a technical method, including a sequence or partial sequence of a gene and this even if the structure of that part is identical to that of a natural part.

Can be protected by a Benelux trademark:

All the signs that can be represented graphically and that are capable of distinguishing the goods or services of an undertaking from those of another, in particular, words, designs, letters, numerals, colors, sounds and shapes of goods or packaging.

Cannot be protected by a Benelux trademark:

• Signs that are devoid of any distinctive character;
• Signs that cannot be represented on the register in a way that allows the public and the competent authorities to determine the clear and precise subject matter of the protection (notably a smell or a taste);
• Signs that have become customary in the current language including the established practices of the trade in terms of signs and indications;
• Signs consisting of a shape which:

• is necessary to obtain a technical result;
• results from the nature of the goods;
• gives a substantial value to the goods;

• Signs likely to deceive or harm the public, meaning signs that are:

• contrary to accepted principles of morality or to public policy;
• likely to deceive the public, with regard to the nature, quality or geographical origin of the goods or services for instance;

• Signs that are not available anymore, meaning signs that are:

• identical or similar to an earlier registered Benelux, European or international trademark designating the Benelux or European territory for identical or similar products or services (or even for different products or services provided that the trademark is renowned);
• identical or similar to a well-known trademark, even if this trademark is not registered in the Benelux or European territory;
• identical to an earlier patronymic name whose owner hasn’t authorized the use, unless the name is widespread;
• identical to a trade name known in the Benelux countries;
• consisting of a work protected by copyright or by a registered design, if the owner hasn’t authorized the use of his work as a trademark;
• identical to a designation of origin or a geographical indication.

 

4. How can patents and trademarks be revoked?

Once in force, Belgian patents and Benelux trademarks can be revoked by the competent Belgian judicial court. Belgian patents can also be revoked voluntarily by the proprietor of the patent or lapse automatically as a result of not paying the annual patent maintenance fees.

A patent can be revoked on the following grounds:

• The subject-matter does not meet the patentability requirements, among which novelty, inventive step and industrial applicability;
• The invention is not disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art;
• The subject-matter of the patent extends beyond the content of the application;
• The proprietor of the patent was not entitled to the patent.

A trademark can be revoked on the following grounds:

• After the 10 years period, if the renewal fee is not payed;
• If the owner of the trademark so requests;
• If the trademark isn’t used during a 5 years period;
• If the grounds for registration weren’t fulfilled;
• If the trademark is used in order to create a confusion to the public;
• If the trademark (usually verbal) became used in the trade as a generic name for certain goods or services.

 

5. Are foreign patents and trademarks recognized and, if so, under what circumstances?

By virtue of Article 2 of the European Patent Convention (EPC), a European patent shall, in each of the Contracting States for which it is granted, have the effect of and be subject to the same conditions as a national patent granted by that State, unless this Convention provides otherwise. This entails that, if the European patent is not validated in Belgium, it cannot be enforced through the Belgian courts. Foreign patents will have no effect in Belgium. In order to obtain patent protection, it is necessary to obtain a Belgian patent or a European patent validated in Belgium.

As stated by Article 2.2. of the Benelux Convention on Intellectual Property, the exclusive right in a trademark under the Convention is acquired by registration of a Benelux trademark or of an international trademark designating the Benelux territory. European trademarks are recognized as well, since the title conferred is unified for the European territory. Foreign trademarks have in contrast no legal force unless they constitute “well-known” trademarks.

A distinction is to be made, however, when it comes to carrying out saisie-contrefaçon proceedings (inspection proceedings or discovery), which is in principle possible also on the basis of a foreign patent or trademark.

 

6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?

The Law of 25 March 1964 on the medicines provides for the “8+2+1” data and market protection approach in line with Directive 2001/83/EC (see also Regulatory, Pricing and Reimbursement Overview, Question 6). This means that the originator company enjoys data exclusivity during the first eight years following the grant of the MA for the reference medicine.

Following the data protection afforded for eight years, the generic company is prohibited from commercialising its product for another two years: this is indeed prohibited for a period of ten years after the grant of the original MA for the reference medicine.

This period of ten years can be extended to eleven years if the MA holder for the reference (originator) medicine obtains one or more new therapeutic indications during the first eight years of this period and if this/these indication(s) is/ are considered an important clinical benefit compared to the existing treatments.

 

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

Please refer to Question 3 above.

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

A license agreement is not subjected to approval by a government or regulatory body. A license agreement pertaining to a patent must be in writing in order to be valid.

A patent or trademark license agreement must be registered with the Belgian Office for Intellectual Property (Dienst Intellectuele Eigendom or DIE) in order to be enforceable vis-à-vis third parties.

 

Also from this Legal Handbook

The low-down on the situation regarding product liability in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.

 

1. What types of liability are recognized in your jurisdiction?

Belgian law distinguishes two types of civil liability: contractual liability and tort liability. Where the first arises from a failure to execute, respect or comply with contractual obligations, the latter arises when certain acts cause harm or damage.

In terms of tort liability, a further distinction should be made between ‘fault liability’ and ‘objective liability’. Fault liability requires that a fault has been committed causing the harm or damage. Fault is a broad term encompassing not only the violation of a legal norm but also any act which is considered illicit. In case of objective liability or risk liability, there is no requirement of such a ‘fault’: the liability is based on the (increased) risk certain activities bring about, as a result of which the mere harm or damage resulting from a certain action is sufficient to trigger liability.

 

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

The manufacturers of medicines and medical devices are subject to the provisions of the Law of 25 February 1991 on product liability. This Law also applies to medicines and medical devices, and establishes a regime of objective liability. This entails that no proof of ‘fault’ must be proven: only the damage, the defect and the causal relationship between those two must be established.

A product is ‘defective’ when it does not provide the safety which a person is entitled to expect, taking all circumstances into account, including:

1. the presentation of the product;
2. the use to which it could reasonably be expected that the product would be put;
3. the time when the product was put into circulation.

 

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

The objective product liability regime of the Law of 25 February 1991 extends not only to the manufacturer, but also to the other participants in the chain from production to sale, including importers, retailers, wholesalers and distributors.

The objective product liability regime does not extend however to corporate executives, employees and representatives. Corporate executives could be held liable for any harmful act that can be qualified as a ‘fault’ that is causally linked to damage of a third party. Employees will, depending on the circumstances, be able to benefit from Article 18 of the Law on the Employment Contracts which provides they are only liable for deceit and grave fault. The employee is only liable for a minor fault if it occurs rather habitually then by chance.

 

4. How can a liability claim be brought?

A liability claim can be brought before the judicial courts.

 

5. What defences are available?

In order to escape liability by virtue of the Law of 25 February 1991, the manufacturer must prove that

1. he did not put the product into circulation; or
2. having regard to the circumstances, it is plausible that the defect which caused the damage did not exist at the time when the product was put into circulation by him or that this defect came into being afterwards; or
3. the product was neither manufactured by him for sale or any form of distribution for economic purpose nor manufactured or distributed by him in the course of his business; or
4. the defect is due to compliance of the product with mandatory regulations issued by the public authorities; or
5. the state of scientific and technical knowledge at the time when he put the product into circulation was not such as to enable the existence of the defect to be discovered; or
6. in the case of a manufacturer of a component, the defect is attributable to the design of the product in which the component has been fitted or to the instructions given by the manufacturer of the product.

 

 

Also from this Legal Handbook

A brief overview of the situation regarding traditional medicines and OTC products in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.

 

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

The Law of 25 March 1964 on the medicines distinguishes between homeopathic medicines, traditional herbal medicines and herbal medicines.

All three categories are subject to a registration procedure before the FAMHP. Homeopathic medicines and traditional herbal medicines can be subjected to a simplified registration procedure provided they meet certain criteria.

 

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

The Royal Decree of 7 April 1995 on information and advertising of medicines for human use explicitly includes homeopathic medicines and traditional herbal medicines in its scope.

Please refer to  Marketing, Manufacturing, Packaging & Labeling, Advertising, Question 17 regarding the obligations for advertising contained therein. The provisions of the Royal Decree involving advertising to the public indeed do not differ much for homeopathic medicines and traditional herbal medicines. Just like advertising for regular medicines should comply with the SmPC, all aspects of the advertising for homeopathic medicines must comply with the data included in the patient information leaflet or the labelling (incl. for information disseminated through a so-called information campaign involving such a product).

One difference is that, for a traditional herbal medicine, advertising to the public must state “traditional herbal medicine for use in one or more specified indications, exclusively based on long-term use”.

 

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

Please refer to Marketing, Manufacturing, Packaging & Labeling, Advertising, Question 17.

 

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

Over-the-counter medicines are subject to the same requirements as prescription medicines and are therefore governed by the Law of 25 March 1964 on the medicines.

 

5. Are there any limitations on locations or channels through which OTC products may be sold?

OTC products may be sold in pharmacies and over the Internet by pharmacies open to the public (see Marketing, Manufacturing, Packaging & Labeling, Advertising, Question 18).

 

6. What health, advertising, and marketing claims may be made for OTC products?

Please refer to Marketing, Manufacturing, Packaging & Labeling, Advertising, Question 17.

 

7. Can OTC products be marketed or advertised directly to the public?

Marketing or advertising to the public is permitted for OTC products though the prohibition of advertising any unauthorized, banned or suspended medicine still applies (please refer to Marketing, Manufacturing, Packaging & Labeling, Advertising, Question 17).

 

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

The Minister of Public Health or his representative can alter the nature of a medicine (such as OTC or prescription-only) either on its own initiative, or following an application of the holder of the marketing authorisation.

 

9. What are the requirements for the importation of either traditional medicines or OTC products?

Please refer to Marketing, Manufacturing, Packaging & Labeling, Advertising, Question 7.

 

 

Also from this Legal Handbook

All about marketing, manufacturing, packaging & labeling, advertising in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.

 

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?

First of all, the medicines must be the subject of clinical trials. These clinical trials must be submitted to the FAMHP and an ethics committee for review and approval (see also Preclinical and Clinical Trial Requirements).

If these clinical trials have been successful, the applicant can submit an application for a MA. Obtaining a MA is a sine qua non condition for the marketing of the medicines on the Belgian market. Such application can be submitted applying one of the following procedures:

i. Centralised Procedure:

Medicines can be authorised by means of a single application procedure at the European Medicines Agency (‘EMA’). It is important to note that some products, such as biological medicines, must be centrally authorised.

The application is assessed by the EMA’s Committee for Medicinal Products for Human Use (‘CHMP’) during a period of maximum 210 days. The CMHP’s scientific opinion is sent to the European Commission for a final decision.

Once granted, the centralised MA is granted with a European authorisation number that is valid in all EU states, Iceland, Liechtenstein and Norway.

ii. Decentralised Procedure and Mutual Recognition Procedure:

The decentralised procedure (‘DCP’) aims to obtain a MA simultaneously in several Member States for a not yet authorised medicine. The applicant can choose the Member States where obtaining a MA is envisaged. Each Member State chosen by the applicant is called a “Concerned Member State” (‘CMS’) and, among those Member States, the applicant has to choose one state that will be responsible for the evaluation of the application and that is called “Reference Member State” (‘RMS’).

The mutual recognition procedure (‘MRP’) enables an applicant to have a MA already obtained in one Member State (=RMS) recognised in one or more other Member States (=CMS).

Following approval, the applicant receives national MAs with national authorisation numbers for each of the Member States involved in the proceeding.

It is mandatory to use one of these two procedures if a MA application has already been submitted in another Member State. These procedures allow also obtaining authorisation for generic medicines of medicines that have already been authorised under the centralised procedure.

iii. National Procedure:

In Belgium, the request for a national MA must be submitted with the FAMHP. The Commission for Medicines for Human Use decides on the benefit/risk balance of a medicine on the basis of three criteria: the efficacy, safety and quality of the medicine. After an assessment, the applicant receives the decision from the Minister or the FAMHP. If positive, the applicant receives a national MA that is only valid on Belgian territory.

 

2. What is the authorization process for the marketing of generic versions of these products?

Please refer to Regulatory, Pricing and Reimbursement Overview, Question 6: “How does the authorisation process differ between brand-name products and generic products?”.

 

3. What are the typical fees for marketing approval?

Please refer to Regulatory, Pricing and Reimbursement Overview, Question 4: “What are the approximate fees for each authorisation?”.

 

4. What is the period of authorization and the renewal process?

Please refer to Regulatory, Pricing and Reimbursement Overview, Question 5: “For how long are marketing authorisations/registrations valid? How are mare marketing authorisations/registrations renewed?”.

 

5. What are the requirements, if any, for post-approval pharmacovigilance?

The bodies within the administrative authorities responsible for assessing and monitoring the safety of human medicines are the Belgian Pharmacovigilance Centre for medicines for human use (‘BPC’) established at the FAMHP, and the Pharmacovigilance Risk Assessment Committee (PRAC) at the EMA.

The MA holder must also set up a pharmacovigilance system (sensu lato), consisting of (i) a pharmacovigilance system that is company specific and (ii) a risk management system that is product specific. The MA holders should keep detailed reports of all possible side effects that have occurred in or outside the European Union, and report to the relevant authorities serious adverse reactions within a maximum period of fifteen days. Additionally, they should also at regular intervals submit actualised periodical reports regarding the safety to the competent authorities.

The MA holder must also appoint a pharmacovigilance manager, called the qualified person responsible for pharmacovigilance (‘QPPV’), who is responsible for the above actions. If the QPPV is not physically present in Belgium, a local contact person should be appointed as well.

Following the evaluation of the pharmacovigilance data, the FAMHP may decide to suspend, withdraw or amend the MA. It must then communicate this decision to the EMA, the other Member States and the MA holder.

 

6. Are foreign marketing authorizations recognized?

Foreign marketing authorisations can only be recognised provided that they are rendered by a Member state of the European Union and not by a third country. In such case, the so-called mutual-recognition procedure should still be followed (see also Question 1 above).

 

7. Are parallel imports of medicines or devices allowed?

Yes, parallel import or parallel distribution of medicines is allowed within the European Economic Area.
When it concerns centrally authorized medicines (i.e. one authorisation for the entire EU), reference is not made to ‘parallel import’, but to ‘parallel distribution’. In such case, a notification of the EMA of the intended parallel distribution is required.

In case of nationally granted MAs, parallel import is allowed, provided that the following conditions are met:

• A MA has been granted in the Member State of origin (part of the EU or of the European Economic Area) for the medicine to be imported;
• A MA has been granted in the Member State of import for the reference medicine;
• The imported and the reference medicine should at least:

o have the same qualitative and quantitative composition in active ingredients;
o have the same therapeutic indications;
o be therapeutically equivalent;
o have the same pharmaceutical form;

• No further differences may exist between the imported and reference medicinal product that could be therapeutically relevant and/or could pose a danger to public health.

The applicant for a parallel import authorisation is required to compile a file and submit it to the FAMHP in order to obtain this authorisation and the setting of the maximum price.

Finally, parallel distribution and import should respect intellectual property rights, such as trade mark rights, and should in this regard comply with the principles that have in this regard been set by the Court of Justice of the European Union.

As for medical devices, once a device has been CE-marked, it can be marketed anywhere in the EU, as long as the general requirements for medical devices are complied with.

 

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?

Belgian law prohibits the requesting, offering, accepting, or providing of “gifts, monetary advantages or benefits in kind” to wholesalers, persons qualified to prescribe, deliver or administer medicines or medical devices and institutions where prescribing, delivering or administering medicines or medical devices take place.

The above prohibition does not apply to:

1. gifts or benefits of limited value that concern medical, dental or veterinarian practices (such as EUR 50 per gift and up to a maximum of EUR 125 per year),
2. invitations and payment of costs for participation in scientific events, including the hospitality of healthcare professionals if certain conditions are met; and
3. the reasonable compensation of legitimate services of a scientific nature (compensation for clinical trials, research papers, symposiums, etc.).

 

9. How is the manufacturing of medicines and devices regulated and by which agencies?

The manufacturing of medicines in Belgium is subject to a manufacturing authorisation. The application for this authorisation must be submitted to FAMHP.

Once this authorisation has been granted, the holder of the authorisation is required to comply with a number of obligations, such as compliance with Good Manufacturing Practices issued by the EMA and the appointment of a recognized qualified person (‘QP’) who can provide services to only one pharmaceutical company and who is responsible for batch release to verify and ensure the quality of the medicines (incl good manufacturing practices when manufactured in Belgium). Compliance with these practices is then monitored by a team of inspectors from the FAMHP’s Inspection Directorate General.

To be put on the Belgian market, all medical devices must bear a CE marking. The procedure depends on the class of the medical device:

• The manufacturer of Class I medical devices may affix the CE marking himself under his own responsibility. However, he is required to notify himself to the FAMHP, which is responsible for controlling the manufacturing processes.
• For Class II (a) medical devices up to Class III medical devices, the CE marking must be authorised by a notified body. A notified body is a private organisation accredited and designated by the FAMHP and then notified to the European Commission. If this body decides to give its authorisation, it shall issue the manufacturer with a certificate of conformity valid for a maximum of five years. This body is responsible for controlling the manufacturing process of those medical devices.

 

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?

Yes, the local manufacturing practices are in accordance with the Good Manufacturing Practices issued by the EMA.

 

11. What is the inspection regime for manufacturing facilities?

The inspection regime is carried out by FAMHP for the manufacturing of medicines and Class I medical devices. By contrast, the inspection regime is carried out by a notified body in the case of Class II (a) medical devices up to Class III medical devices (see also Question 9 above).

 

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

Statutory agents or permanent employees of FAMHP (or, in some cases, judicial officers) shall carry out the inspections. Nevertheless, those inspections may be conducted at the request of other agencies, including the FDA/EMA.

 

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

Apart from the fact that these acts can only be carried out by an entity that has a wholesale license, the storage, packaging and handling of medicines and medical devices shall also comply with:

• The Guidelines of 7 March 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01);
• The principles and guidelines on good distribution practices included in Annex V of the Royal Decree of 14 December 2006.

 

14. What information must be included in medicine and device labeling?

The labeling of a medicine shall be drawn up in accordance with the SmPC and shall contain the following information:

1) For the identification of the medicine:

1. the name of the medicinal product followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults. The common name shall be included where the product contains only one active substance and if its name is an invented name;
2. the pharmaco-therapeutic group or type of activity in terms easily comprehensible for the patient;

2) The therapeutic indications;

3) A list of information which is necessary before the medicinal product is taken:

1. contraindications;
2. appropriate precautions for use;
3. forms of interaction with other medicinal products and other forms of interaction (e.g. alcohol, tobacco, foodstuffs) which may affect the action of the medicinal product;
4. special warnings;

4) The necessary and usual instructions for proper use, and in particular :

1. the dosage;
2. the method and, if necessary, route of administration;
3. the frequency of administration, specifying if necessary the appropriate time at which the medicinal product may or must be administered;
4. and, as appropriate, depending on the nature of the product:
5. the duration of treatment, where it should be limited;
6. the action to be taken in case of an overdose (such as symptoms, emergency procedures);
7. what to do when one or more doses have not been taken;
8. indication, if necessary, of the risk of withdrawal effects;
9. a specific recommendation to consult the doctor or the pharmacist, as appropriate, for any clarification on the use of the product;

5) a description of the adverse reactions which may occur under normal use of the medicinal product and, if necessary, the action to be taken in such a case;

6) a reference to the expiry date indicated on the label, with:

1. a warning against using the product after that date;
2. where appropriate, special storage precautions;
3. if necessary, a warning concerning certain visible signs of deterioration;
4. the full qualitative composition (in active substances and excipients) and the quantitative composition in active substances, using common names, for each presentation of the medicinal product;
5. for each presentation of the product, the pharmaceutical form and content in weight, volume or units of dosage;
6. the name and address of the marketing authorisation holder and, where applicable, the name of his appointed representatives in the Member States;
7. the name and address of the manufacturer;

7) where the medicinal product is authorised in accordance with Articles 28 to 39 under different names in the Member States concerned, a list of the names authorised in each Member State;

8) the date on which the package leaflet was last revised.

The information on the labeling of a medical device depends on the type of medical device, but shall least contain at least the following information:

1. the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;
2. the details strictly necessary to identify the device and the contents of the packaging especially for the users;
3. where appropriate, the word ‘STERILE’;
4. where appropriate, the batch code, preceded by the word ‘LOT’, or the serial number;
5. where appropriate, an indication of the date by which the device should be used, in safety, expressed as the year and month;
6. where appropriate, an indication that the device is for single use. A manufacturer’s indication of single use must be consistent across the Community;
7. if the device is custom-made, the words ‘custom-made device’;
8. if the device is intended for clinical investigations, the words ‘exclusively for clinical investigations’;
9. any special storage and/or handling conditions;
10. any special operating instructions;
11. any warnings and/or precautions to take;
12. year of manufacture for active devices other than those covered by (e). This indication may be included in the batch or serial number;
13. where applicable, method of sterilization;
14. in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.

In Belgium, it is mandatory that this information be made available in the three national languages: German, French and Dutch.

 

15. What additional information may be included in labeling and packaging?

All the information necessary to use the medicine or medical device safely provided that it complies with the criteria set out in Question 16 (below) may be included in labeling and packaging. The specific characteristics of certain medicines or medical devices may therefore be included.

 

16. What items may not be included in labeling and packaging?

The packaging may not include any element, logo, sign or pictogram that:

• Is contrary to the summary of product characteristics as approved by the FAMHP;
• Is contrary to the Guideline on readability;
• Is false;
• Is confusing;
• Is contrary to rules of decency;
• Is promotional;
• Does not contribute to health information.

 

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

Advertising is always prohibited for unauthorised, banned or suspended medicines. Advertising is further prohibited to the general public for medicines that can be obtained only with a medical prescription and for narcotics and psychotropics. Medicines that may be advertised to the general public are medicines that, according to their composition and purpose, are intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary.

When permitted, the advertising has to comply with the general rules surrounding all advertising and aimed at protecting consumers, as well as the specific rules such as:

• It shall comply with the particular listed in the summary of product characteristics;
• It shall encourage the rational use of the medicine, by presenting it objectively, without exaggerating its properties and without being misleading;
• It shall be accurate, up-to-date, verifiable;
• It shall not contain any element that:

• gives the impression that a medical consultation or surgical operation is unnecessary, in particular by offering a diagnosis or by suggesting treatment by mail;
• suggests that the effects of taking the medicine are guaranteed, are unaccompanied by adverse reactions or are better than, or equivalent to, those of another treatment or medicine;
• suggests that the health of the subject can be enhanced by taking the medicine, or that the health of the subject could be affected by not taking the medicine (except for vaccination campaigns and information campaigns about vaccines);
• is directed exclusively or principally at children;
  o refers to a recommendation by scientists, health professionals or persons who are neither of the foregoing but who, because of their celebrity, could encourage the consumption of medicines;
• suggests that the medicine is a foodstuff, cosmetic or other consumer product;
• suggests that the safety or efficacy of the medicine is due to the fact that it is natural;
• by a description or detailed representation of a case history, could lead to erroneous self-diagnosis;
• refers, in improper, alarming or misleading terms, to claims of recovery;
• uses, in improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of a medicine on the human body or parts thereof;
• would use images, drawings, photographs or representations liable to infringe on the very essential informational character and the restraint which must characterise the advertising of medicines or which, on the part of the persons to whom they are addressed, would use grounds other than those rationally persuading them to use a medicine for the purpose of the treatment or prevention of a disorder or a disease, in the course of making a medical diagnosis, or for the purpose of restoring, correcting or modifying organic functions;

• It shall bear the words “this is a drug, not for prolonged use without medical advice”;

Advertising is for medical devices is not allowed for devices not bearing the CE marking. Advertising to the public for implantable medical devices and for the acts of performing them is also prohibited. This prohibition may be extended to other medical devices depending on the risk they pose to public health. However, advertising to the public for other medical devices is permitted.

It should also be noted that the rules are different when advertising is addressed to health care professionals.

 

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

Medicines can only be sold and delivered to the public by pharmacists in a pharmacy open to the public or by hospital pharmacists. Medical devices can be sold not only by pharmacists, but also by any distributor or even by the device manufacturer.

The delivery of medicines in the pharmacy remains the basic principle. However, an exemption is provided for pharmacies open to the public and authorised in Belgium to sell via the Internet, under very strict conditions, authorised and non-prescription medicines and certain medical devices (see Question 19 below). The ordered product is then delivered via post, brokers or deliverers.

 

19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?

When a pharmacist wishes to sell medicines via the Internet, he must notify the FAMHP and the Order of Pharmacists, via the appropriate form, within one month of the publication of his website.

The pharmacist’s website must comply with a number of conditions. First, it must be designed to promote the rational use of medicines and medical devices, in particular by presenting them in an objective and non-misleading manner and without exaggerating their properties. The website must also contain a certain amount of mandatory information, which is listed in Article 29 of the Royal Decree of 21 January 2009 on instructions for pharmacists. For example, the pharmacist is required to indicate on his website the information contained in the notice of the medicine or medical device offered for sale.

There are no specific legal rules on advertising on the Internet. Therefore, it is subject to the general rules applicable to the advertising of medicines and medical devices (see Question 17 above). However, advertising for medicines by electronic mail is expressly prohibited.

 

20. May medicines and devices be advertised or sold directly to consumers?

Regarding advertising, please refer to Question 17: “What are the restrictions and requirements for the marketing and advertising of medicines and devices?”.

Regarding sale, please refer to Question 18: “Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?”.

 

21. How is compliance monitored?

The advertising of medicines distributed to the general public are subject to control prior to their distribution:

• Advertising broadcast on radio or television requires a prior visa to be granted by the Minister of Public Health, on the advice of the Medicines Advertising Control Commission.
• All types of advertising other than radiophonic or televisual advertising must be notified to the FAMHP at least 30 days before broadcast.

In addition, the MA holder must collaborate with an information officer approved by the Minister. This officer is responsible for checking in advance whether the holder’s advertising practices are in compliance with the regulations relating to the advertisements for medicines. This compliance is regularly verified by the FAMHP.

 

22. What are the potential penalties for noncompliance?

In such case, the Minister may suspend or withdraw the approval of the information officer or withdraw the visa. If the Minister or the FAMHP consider it necessary to protect the public interest, they may order the cessation or prohibit an advertising campaign for a medicine.

The sanctions mentioned in Regulatory, Pricing and Reimbursement Overview, Question 9 may also apply.

 

 

Also from this Legal Handbook

All legal aspects surrounding preclinical and clinical trial requirements in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.

 

1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?

No, clinical trials are not required to be conducted locally to receive marketing approval in Belgium. In order to obtain marketing approval, for new drugs, the necessary information and data regarding the efficacy, safety and quality of the medicine should be submitted (see also Chapter III, Question 22).

Where the clinical trials have been carried out outside the EU, they must have been conducted in accordance with principles equivalent to those applicable in the EU (in particular with regard to the protection of participants and transparency).

 

2. How are clinical trials funded?

In Belgium, the funding of clinical trials varies according to the type of trial:

• Commercial clinical trials are funded by pharmaceutical companies (i.e. 77% of trials in 2018) ;
• Non-commercial clinical trials are funded by the State (health care budget) or by universities, foundations or charitable organisations;
• Other clinical trials are funded by scientific research funds or charitable organisations.

 

3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?

Clinical trials, involving human subjects, are subject to stringent requirements stipulated in the Law of 7 May 2004 on experiments on the human person. These requirements do not apply to preclinical studies which are carried out in vitro or in vivo using lab animals.

To carry out a clinical trial in Belgium, the following requirements should be met :

• The clinical trial is scientifically justified and based on the latest scientific knowledge and a sufficient preclinical experiment;
• The clinical trial aims to increase the knowledge of humans or means that can improve their existence;
• There is not alternative method which is similarly effective and allows to achieve the same results;
• The foreseeable risks and disadvantages have been weighed against the individual benefit for the participant as well as other people;
• The evaluation leads to the conclusion that the expected therapeutic and public health advantages outweigh the risks;
• The participant has provided his/her consent (see also Question 4 below);
• The clinical trial is conducted under the responsibility of a health care professional.
• The investigator and sponsor have taken care of insurance and coverage of their liability (see also Question 5 below).

The investigator must submit a clinical trial application (‘CTA’) to a fully accredited ethics committee and to Minister (with delegated authority to the FAMHP). The CTA includes inter alia the protocol and a summary there-of, investigator’s brochure (‘IB’), investigational medicinal product dossier (‘IMPD’) (in the form of a so-called Common Technical Document – ‘CTD’) and other documents.

The trial protocol shall particularly describe the objective(s), design, methodology, statistical aspects and organization of the clinical trial. The SmPC may replace the IB and IMPD if the investigated medicinal product is authorized in a EU member state and if it is used according to the MA.

The clinical trial may only be carried out under certain conditions, including the approval of an ethics committee and the Minister on the trial protocol.

When the clinical trial is carried out on a minor, an incapable adult or in an emergency, additional conditions are imposed on the ethics committee regarding the approval to be given on the protocol.

 

4. What are the requirements for consent by participants in clinical trials?

A person may only participate in an experiment if he (or she) has given his (or her) free and informed consent. This consent must be given in writing. Additional conditions must be met in the event that the participant is a minor or an incapable adult or when consent cannot be obtained due to the urgency of the situation.

It is also essential that certain information be provided to the volunteer in advance, in writing and in a clear and understandable manner. This information shall include in particular the nature, scope, objectives, consequences, expected benefits, risks of the experiment, the circumstances in which it takes place and the identification and opinion of the competent ethics committee.

The volunteer must also have been informed that he (or she) may withdraw his (or her) consent at any time and without prejudice.

 

5. May participants in clinical trials be compensated?

Participants in clinical trials can receive a compensation for participating in the trial, as well as an indemnity for any costs incurred and the time spent on medical research. The indemnity is not determined according to the potential risk incurred.

For a minor, an incapable adult or when consent cannot be obtained due to the urgency of the situation, there can be no incentives, whether financial or not, except for an indemnity of costs incurred.

Additionally, participants also benefit from free treatment that is the subject of the study, and usually also free examinations carried out as part of the clinical trial.

 

6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?

The sponsor is objectively liable for any damage the clinical trial causes to the participants (or, in the event of death, to their beneficiaries), whether the damage is directly or indirectly related to the clinical trial. Any clause stipulating the opposite will be considered null and void.

Prior to the start of the clinical trial, the sponsor must provide insurance to cover its liability and the liability of any intervener in the clinical trial (see also Question 2 above).

 

 

Also from this Legal Handbook

An intro to the legal situation for regulatory, pricing and reimbursement in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.

 

1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

The Federal Agency for Medicines and Health Products (‘FAMHP’) is the competent authority for drugs, biologicals and medical devices in Belgium. In particular, the FAMHP is in charge of controlling the quality, safety and efficacy of those products.

The Federal Public Service of Economy (‘FPS Economy’) sets the prices of those products.

The National Institute for Health and Disability Insurance (‘NIHDI’) sets the conditions for reimbursement of those products.

 

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

For drugs and biologicals, the general framework, including in relation to the authorisation, of drugs, biologicals and medical devices can be found in the following laws and regulations:

• Law of 25 March 1964 on medicines;
• Royal Decree of 14 December 2006 on medicines for human and veterinary use;
• Law of 15 December 2013 on medical devices;
• Royal Decree of 15 July 1997 on active implantable medical devices;
• Royal Decree of 18 March 1999 on medical devices;
• Royal Decree of 14 November 2001 on in vitro diagnostic medical devices.

Specific provisions relating the pricing of medical products and certain medical devices are found in:

• Royal Decree of 10 April 2014 (Royal Decree laying down the conditions of admissibility, time limits and practical arrangements for price fixing requests, price increase requests, price notifications and (price) communications of medicines, objects, apparatus and substances similar to medicines, and raw materials).

Finally, the reimbursement of the medical products is governed by :

• Law of 14 July 1994 on compulsory health insurance and compensation;
• Royal Decree of 1 February 2018 laying down the procedures, time limits and conditions for the intervention of compulsory health care insurance and compensation in the costs of pharmaceutical specialties;
• Royal Decree of 24 June 2014 laying down the procedures, time limits and conditions for the intervention of compulsory health care insurance and compensation in the costs of implants and invasive medical devices.

 

3. What are the steps to obtaining authorization to develop, test, and market a product?

The authorisation for medicines can be obtained via the following steps:

1. Pre-clinical trials;
2. Clinical trials;
3. Marketing authorisation (‘MA’).

The MA can be requested by introducing a national procedure, a centralised procedure, a mutual recognition procedure or a decentralised procedure (see also Marketing, Manufacturing, Packaging & Labeling, Advertising, Question 1).

The procedure to obtain an authorisation for medical devices is quite different. To put a medical device on the market, it needs to bear the CE marking. Depending on the class of the medical device, the marking must either be submitted to a notified body for approval and/or be notified to the FAMHP (for more details, please refer to Marketing, Manufacturing, Packaging & Labeling, Advertising, Question 9).

 

4. What are the approximate fees for each authorization?

The fees for the MA of the medicines are the following, depending on the type of procedure chosen by the applicant:

Type of Procedure			Fees*
National Procedure		Full MA	31.855,39 €
		Generic MA	27.725,57 €
Centralised Procedure			From 291.800,00 €
Decentralised Procedure and Mutual Recognition Procedure	If Belgium = CMS	Full MA	10.838,86 €
		Generic MA	9.324,08 €
	If Belgium = RMS	Full MA	51.153,47 €
		Generic MA	42.960,36 €

* Fees for 2019 and for each file submitted.

The fees for medical devices are as follows:

Type of Medical Device	Fees*
Notification of clinical research for active implantable medical devices	10.436,42 €
Notification of clinical research for medical devices in vitro diagnostic medical devices	10.436,42 €
Notification of clinical research for in vitro diagnostic medical devices	393,85 €

* Fees applicable as from 31 May 2019.

 

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?

MAs are valid for five years. An application for renewal of a national MA must be submitted through the national procedure or the mutual recognition procedure at least nine months prior to the expiring date of its validity. After the first renewal, MAs are valid for an indefinite time.

Since 1 January 2016, the use of the electronic form for the submission of a MA renewal application has become mandatory.

The fees that have to be paid for renewal are the following:

Procedure		Fees*
National Procedure		5.905,59 €
Centralised Procedure		14.400,00 €
Decentralised Procedure and Mutual Recognition Procedure	If Belgium = CMS	1.070,58 €
	If Belgium = RMS	12.035,33 €

* Fees for 2019.

 

In the event of duly justified reasons related to pharmacovigilance (please refer to Marketing, Manufacturing, Packaging & Labeling, Advertising, Question 5), the FAMHP may require an additional five years renewal at the same conditions than the first one.

 

6. How does the authorization process differ between brandname products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?

Generic products can be authorized through a so-called abbreviated procedure, meaning that the applicant is not required to submit a complete file to receive a MA and can rely on the documents already submitted for the brandname product.

The presentation of pre-clinical and clinical trials is not required if the applicant can demonstrate that the medicine for human use is a generic of a reference medicine for human use which is or has been authorised for at least eight years in Belgium or in another Member State (i.e. so-called data protection). Once this period of data exclusivity has expired, the MA application can be submitted, as well as the pricing and reimbursement application. However, an additional two (or in some cases three) year period is required before the generic drug can be marketed (i.e. so-called market protection).

The same rules apply equally to local and foreign manufacturers.

 

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?

There is no specific regulation for combined products. The combination of medical devices and/or medicines requires that both products have individually obtained the respective authorisations.

However, it is important to emphasize that even if biologic products are classified as medicines, they are subject to different rules than the medicines in general.

 

8. How is compliance with regulations monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?

The FAMHP is responsible for monitoring the correct application of the laws and decrees in force in the field of medicines. To this end, the FAMHP is legally authorised to carry out inspections, searches, analyses, interrogations, seizures, etc. within companies operating in the medical field.

The regulatory regime is based on the EU directives on medicines and medical devices and is in line with the European Medicines Agency expectations and requirements.

 

9. What is the potential range of penalties for noncompliance?

In the event of a violation of one of the above-mentioned provisions, the FAMHP may impose various sanctions such as: imposing an administrative fine, withdrawing or adapting official documents, taking a health measure or introducing a ban.

In case of serious violations, the firms are also liable to criminal sanctions, namely imprisonment from eight days to three years and/or a fine of 50,00€ to 100.000,00 €.

 

10. Is there a national healthcare system? If so, how is it administered and funded?

Any person residing in Belgium is subject to a regime of compulsory insurance. Any Belgian resident over 25 years (whether they are employees, self-employed, unemployed, retired, students, etc.) must join a Belgian health insurance fund, which allows them to access publicly funded health care. Indeed, the health insurance funds allow the insured party to be reimbursed in whole or in part for certain medical intervention and medicines.

Sources of funding for the health care system include the following:

• Social contributions paid by employers, workers and self-employed persons;
• State subsidies;
• A percentage of VAT revenues.

These funds are managed by the NIHDI, which is the federal body that organises, manages and controls health care in Belgium, which in turn distributes the funds received between the various health insurance funds.

 

11. How does the government (or public) healthcare system function with private sector healthcare?

The public healthcare system is the mandatory system under Belgian law and it reimburses treatment at an official price per intervention. Still, there is a difference for what the type of healthcare professional, conventionalised or not, is concerned.

The health insurance fund comes to an agreement with the healthcare professionals, inter alia regarding the prices. Healthcare professionals who agree with the official prices, are conventionalised and obliged to charge the official prices only. Partially conventionalised healthcare professionals charge the official prices in certain facilities (e.g. the hospital) and own prices in other facilities (e.g. their own private practice). Non-conventionalised healthcare professionals always charge their own prices.

 

12. Are prices of drugs and devices regulated and, if so, how?

Once the marketing authorisation is granted, the pharmaceutical firm can only market the product following the setting of a maximum price by the FPS Economy. The request for setting the price must be submitted to the Pricing Service of the FPS Economy. Within 90 days and after the latter has issued an opinion, the Minister of the Economy takes a ministerial decree indicating the maximum authorised price for the medicine.

For reimbursable medicines, the procedure for admission to reimbursement by the Drug Reimbursement Commission of the NIHDI is carried out in parallel with the price setting procedure.
The procedure is slightly different for generic medicines. The request for setting the price has to be addressed to the Pricing Service, which issues a decision setting the maximum price for the generic drug within 30 days.

Medical devices, implants and hearing aids are also subject to price control. The request for setting the price must be submitted to the Pricing Service of the FPS Economy. Within 90 days, the Minister sets the maximum authorised price of the medical device in a ministerial decision. In addition, a request for price notification will have to be reintroduced in some cases, such as for innovations made to an existing implant.

Thereafter, if the company wishes to increase the price of the medicine or the medical device, a request has to be made to the Pricing Service.

 

13. How are the drugs and devices used by patients paid for? What roles do public and private payers play?

Patients enjoy a wide coverage offered by social security. As a result, a significant portion of medicines is fully or partially reimbursed. The reimbursement rate varies according to the category in which the medicine is classified. There are 6 categories ranging from category A (100% refunded) to category D (no refund).

The NIHDI is the body that implements the rules for the reimbursement of medicines and medical devices.

A medicine is reimbursable if the following conditions are met:

• The pharmacist receives a prescription written by a general practitioner, specialist, dentist or midwife ;
• The pharmacist delivers the medicine ;
• The medicine is listed on one of the lists of medicines for which reimbursement is provided;
• The reimbursement conditions are respected.

For medical devices, the conditions for reimbursement vary according to whether they are non-implantable medical devices, implants and invasive medical devices or certain services provided by bandagers.

In practice, when the patient goes to a pharmacy, (s)he generally benefits from the “third-party payer system”. This basically means that if the medicine or medical device meets the required conditions, the patient does not have to pay the full amount of the price but only its personal part, called the “user charge provision”. It is also possible that the medicine or the medical device is fully reimbursed and the patient does not have to pay anything.

 

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

Medicines can only be dispensed through pharmacists (a public pharmacy or hospital pharmacy). The profession of pharmacist is only accessible to the holder of a legal diploma of pharmacy who is registered on the list of the Order of Pharmacists.

The pharmacist’s remuneration differs depending on whether the medicine is reimbursable or not:

i. Remuneration for non-reimbursable medicines:

The distribution margins for non-reimbursable medicines are calculated on the selling price excluding VAT, and are set as follows:

• Selling price including VAT ≤ 25,43 €: 31% of the selling price excluding VAT;
• Selling price including VAT > 25,43 €: 7,44 € per presentation.

ii. Remuneration for reimbursable medicines:

The pharmacists’ remuneration for reimbursable medicines consists of three pillars: a distribution margin, a basic fee per delivery and, potentially, and possibly a specific fee for a particular pharmaceutical care.

An agreement between pharmacists and insurers stipulates the fees for compounding and dispensing of reimbursable pharmaceutical products and specialities. The distribution margins for reimbursable medicines are calculated on the ex-factory price excluding VAT, and are set as follows:

• Ex-factory price excluding VAT ≤ 60 €: 6,42% of the ex-factory price excluding VAT;
• Ex-factory price excluding VAT > 60 €: 3,85 € + 2,12 of the ex-factory price excluding VAT.

As far as medical devices are concerned, pharmacies are not the only ones able to dispense them. Since February 2019, the distribution channel for medical devices is open. They can therefore be purchased from any distributor or even from the device manufacturer.

 

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

One of the pharmacist’s main obligations is to provide a medicine in accordance with the doctor’s prescription. There is no doubt that this obligation is an obligation of result.

In addition, the pharmacist has a marginal duty of verification. He is required to refuse to supply any medicine considered “manifestly” dangerous or contraindicated. Since the pharmacist is neither qualified nor materially capable of making a diagnosis and verifying the accuracy of the recommended treatment, he is only required to detect gross errors.

Finally, at the time of dispensing, the pharmacist has to clearly inform clearly the patient of the effects of the medicine, contraindications, side effects, interactions, possible precautions, doses and modalities of its use, without undermining the patient’s confidence in his doctor.