Contact us X


News

Healthcare Transparency Register concept law

May 14, 2019

The Netherlands 

On 30 April 2019, the concept text for the Healthcare Transparency Register law was presented for consultation. With this concept law, the obligation for suppliers of medicines and medical devices to report financial relationships with healthcare professionals and patient organizations to the Healthcare Transparency Register becomes legally anchored.  

The concept law anticipates the evaluation of the Healthcare Transparency Register that is currently being carried out by the Institute for Rational Use of Medicine. The results of this evaluation are expected by the end of this summer. 

The Healthcare Transparency Register Foundation will study the concept law and involve it in the results of the evaluation.

Source 

Google Ads as unacceptable advertising

May 14, 2019

The Netherlands

In the Netherlands, the court has ruled on a case in which a medical search term led to a Google Ad for a food supplement. The court decided that this is unacceptable publicity for medicines.

The Google Ad for the food supplement appeared after typing in a medical search term.  Although the advertising agency had been explicitly instructed otherwise, the Google advertising did appear after typing in the medical search term. The court judged that this was not sufficiently supervised by the advertising agency.

The court ruled that the advertiser was in violation of the Medicines Act, by advertising on the internet for unregistered medicines. In this case, the unregistered medicine was the food supplement, positioned as a medicine by the medical search term.

With fines around 140.000€, it is of interest to know search terms are considered an integral part of a Google advertisement and excluding certain search term categories does not shield an advertiser from a possible violation. Therefore, it is advised to exclude a list of exact keywords and present this as such to KOAG/KAG for approval.

More information can be found here.

Policy adjustment of patient information on the MEB website

May 9, 2019

The Netherlands

The Medicines Evaluation Board (MEB) will no longer publish full product information about the active substance of generic medicines on its website if there is still a patent on one of the indications.

A generic drug may not be sold for indications that the brand drug manufacturer still has a patent on. That is why the patented indication is not included in the package leaflet for the generic medicine. The paper package leaflet for the generic substance therefore referred to the full package leaflet on the MEB website. In the importance of providing good patient information, the MEB published the complete product information of certain generic medicines on its website, whereby indications for which patents still existed were also stated.

This policy was legally challenged in 2016 by manufacturer Warner-Lambert, who found that this publication policy meant that more often generic drugs were prescribed for conditions for which the branded drug should have been prescribed.

The European Court of Justice issued a judgment on this matter on 14 February 2019. As a result, the information on patented indications, that the manufacturer of the generic medicinal product is not allowed to promote, will no longer be published in the information on the generic product on the MEB website. In the package leaflet for generic medicines, the reference to the Medicines Information Bank will be deleted. From now on, it will be indicated that the patient can contact his doctor or pharmacist if he has any questions about the use of the product in the case of conditions that are not mentioned in the package leaflet.

More information can be found here.

New Royal Decree with regards to the implementation of the Falsified Medicines Directive

May 9, 2019

Belgium

On February 8, 2019, the Belgian Official Gazette published a Royal Decree amending both the Royal Decree of 14 December 2006 on medicinal products for human and veterinary use and the Royal Decree of 21 January 2009 concerning instructions for pharmacists.

The modifications that have been made with regards to the implementation of the Falsified Medicines Directive, include: “Without prejudice to Article 6septies, § 2 of the Act, the unique identification mark is included on the packaging of all reimbursable, non-prescription medicines whose reimbursement is not limited to delivery at the hospital.”

More information can be found here.

EU-US Mutual Recognition Agreement for inspections

May 8, 2019

EU

With the Mutual Recognition Agreement between Europe and the US, inspections are to be mutually recognised in the future. The FDA’s approval of the EU Member States proceeds successively. Two more countries have recently been approved: Bulgaria and Cyprus. That makes 24 approved EU states so far. There are 4 countries left: Germany, the Netherlands, Luxembourg and Slovakia. By 15 July, 2019 though, all authorities and countries are supposed to have been reviewed and approved. Regular updates may be found in a question and answer document on the EMA’s website.

New law on saving measures 2019

April 25, 2019

Belgium

A new approved law on the saving measures for 2019 will enter into force on 1 April 2019. It contains the legislative amendments necessary for the implementation of the various cost-cutting measures decided in the framework of the National Institute for Health and Disability Insurance (NIHDI)’s budget for medicines for 2019.

The new law includes following amendments (in short):

  •  The introduction of a “volume cliff”, replacing the current 2.41% price reduction with a new percentage.
  •  A change to the definition of “cheap medicines” by reducing the maximum permitted price deviation from 20% to 10% for groups of medicines for which there are not 3 different alternatives within the 5% price range.
  •  The introduction of prescription quotas “cheap” for physician-specialists in hospitals for medicines issued to outpatients through the hospital pharmacy.
  •  The extension of the system of ceiling prices to medicines which are only reimbursed when issued by a hospital pharmacy.
  •  The reduction of the billing in hospitals for contrast medicines or medicines for which there is a generic or biosimilar competitor, from 90% to 85%.
  •  Exceptionally, and only for 2019, the amount of the compensation levy (the claw-back tax) is set at a minimum of 105 Mio EUR.
  •  The members of the government sitting on the General Council of NIHDI and the members of the Court of Auditors can be provided with information about the refunds offered in the context of the so-called Article 81 or Article 111 contracts, provided that they sign a non-disclosure agreement.

Source: Pharma.be

Encoding errors in the Article 57 database of EMA

April 9, 2019

Belgium

The FAMHP  Vigilance department has found several encoding errors in the Article 57 database of the EMA. Some medicines licensed in Belgium appear two or three times in the database, in two or three national languages. As a result, they are registered multiple times for the same marketing authorization (MA). Every medicine may only be coded once based on the MA number (BE #).

As MA holders are encouraged by EMA to carefully check and correct the registered entries of their different medicines in the database if necessary, FAMHP is asking marketing authorization holders to check whether their registered data are correct.

 

More information can be found here.

New EMA pilot project helps to facilitate validation of initial marketing authorisation applications

March 15, 2019

Europe

EMA launched a five-month pilot study to increase the correct submissions of initial marketing authorisations applications (MAAs). The pilot is a result of the 2016 EMA survey that showed validation issues occur in 90% of all initial applications.

The pilot study consists of an authomated checklist that will help companies assess the level of completion and consistency of the various sections in their application. EMA encourages applicants to submit the validation checklist as part of the MAA dossier. In addition, comments to the checklist may be sent to checklist_ima@ema.europa.eu for further evaluation and improvement of the current validation process.

More information can be found here.

New report form for falsified medicines

March 15, 2019

The Netherlands

Since February, all prescription medicines have a unique code and sealed packaging. The purpose of these safety features is to detect counterfeit medicines in the regular distribution channel. Any problem with the code or the seal can be reported within 24 hours via the report form for falsified medicines.

More information can be found here.

FASFC-Brexitportal

March 13, 2019

Belgium

As from March 30, 2019, the United Kingdom (UK) will no longer be a member of the European Union (EU). Although to date, no agreement between the EU and the UK has been approved, the companies involved in Brexit should anticipate the consequences as much as possible.

As a result of Brexit, new import and export rules will enter into force within a certain period and under conditions that are currently still to be defined. The Belgian Federal Agency for the Safety of the Food Chain (FASFC) will have to carry out import and export controls, mainly focusing on products that pose a risk in the areas of plant health, animal health and food safety. Companies that want to export to the UK or import from the UK must be aware of this and take this into account. If the EU and UK reach an agreement on Brexit, a transition period will apply until the end of 2020 in which all current European rules for the UK remain applicable.

A Belgian portal site on Brexit (www.belgium.be/brexit) has been made available so that companies can easily access all useful information in the context of Brexit. On this National portal, the FASFC also provides a specific FASFC site for companies and a contact centre to support the companies involved as well as possible.

More information can be found here.