Disclaimer:
This Newsletter is intended to provide general information on the members of
conférence bleue and on recent developments of relevance to the pharmaceutical
sector. The information and opinions which it contains are not intended to
provide legal advice, and should not be treated as a substitute for specific
advice concerning particular situations.
A Newsletter Published by the Members of conférence bleue
July 2009 / Issue 22
Second Opinion Procedure, Munich, Germany
The New Reference Price System For Medical Products In Finland, Helsinki, Finland
Changes to Lithuanian Pharmacy Law, Lithuania
The Paediatric Regulation – New Swedish guidelines, Stockholm, Sweden
The Government Submits its Proposal on Deregulation of the Pharmacy Market, Stockholm, Sweden
In general, the pharmaceutical manufacturers in Germany are free to set their prices in the out-patient sector of the Statutory Health Insurance (SHI) at will. No legal obligations exist to agree with the SHI on a certain price in order to ensure the reimbursement of medicines in the out-patient sector. However, certain indirect measures can be imposed by competent bodies to influence the price after the marketing of the product, e.g. Festbetragsregelung (reference price system). This reference price system applies to medicines with (i) the same active substances, (ii) pharmacologically and therapeutically comparable active substances, or (iii) therapeutically comparable effects, in particular combination medicines. In addition, the German legislator has recently introduced the Zweitmeinungsverfahren (second opinion procedure). The competent authority (Joint Federal Committee) may impose this procedure on, inter alia, cost-intensives medicines. It contains an obligation for the prescribing physician to request an evaluation by another physician to confirm or re-evaluate the diagnosis and treatment plan of the physician in the first place, or to offer an alternative diagnosis and/or treatment approach. On 19 March, 2009, the G-BA enacted a guideline defining to which the procedure applies. However, the actual application of this guideline is still not certain for the time being. Therefore, the future will show whether this instrument will be used frequently by the Joint Federal Committee and, in consequence, this additional burden for reimbursement in the out-patient sector will serve as a motivation for pharmaceutical manufacturers to be reluctant with regard to high prices.
Finland introduced a reference price system on 1 April 2009, to compliment the generic substitution adapted 2003. The new system changed the procedures regarding the reimbursement status and prices of medicinal products.
The Finnish reference price system consists of reference price groups which are based on the list of interchangeable products for generic substitution, compiled by the Finnish National Agency for Medicines (NAM). Interchangeable medicinal products, which have the same quantity of the same active pharmaceutical substance, are biologically equivalent to each other, possess a marketing authorisation, and which have been certified reimbursable, are included into the reference price system.
The prerequisite for establishment of a reference price group is that a group of interchangeable medicinal products includes at least one reimbursable product and one generic product on offer. Originator products and parallel import products can be included into reference price system only when there is a reimbursable generic product in the reference price group. Parallel import products are treated correspondingly to original products in the reference price system, so a reference price group is not formed if there are no generic products in the market, but only originator products and parallel import products.
The definition of the reference price is based on wholesale prices presented by pharmaceutical firms and retail prices (including VAT), calculated on the basis of wholesale prices. Reference price is the price of the most affordable product in the reference price group plus 1.5 Euros. If the price of the most affordable product is 40 Euros or more, the reference price is the retail price plus 2 Euros. Reference prices are updated quarterly and are in force for three months.
The reference price for the products in a reference price group is the highest price from which the amount of reimbursement can be calculated. The pharmacies are bound to the rules of generic substitution, so they are obliged to change a substitutable product to a more affordable option according to the rules set by Medicines Act. If a consumer refuses such substitution and wants to buy a medicinal product that is more expensive than the reference price, expenses exceeding the reference price are entirely paid by the consumer. However, if a physician assesses a certain medicinal product to be necessary on the basis of medical grounds, the reimbursement is paid based on the price of the medicinal product prescribed by the physician, and not based on the reference price.
On 16 December 2008 the Parliament of Lithuania adopted the amendments to the Law on Pharmacy (No XI-59, Official Gazette, No 149-5991).
Firstly, the amendments mainly concern abolishing a category of products of special medicinal purpose. The mentioned group will be abolished from 1 July 2009.
Prior to effectuation of the amendment to the Pharmacy Law the products of special medicinal purpose were treated as a pharmaceutical product and were included into the scope of regulation of the Pharmacy Law as well as other related laws. Thus placing on the market of products of special medicinal purpose was subject to certain regulatory procedures such as registration as well as compliance with established rules on handling, marketing, etc.
The abolishment of this special category of products was instigated in order to harmonize national laws with EU legislation, which does not separately differentiate such a category of products, with respect to which the rules in the area of pharmaceutical products would be applicable. Thus, establishing domestic regulation for such group of products could create obstacles for a principle of free movement of goods and impede internal trade and, therefore, infringe the EU law.
The products, which were registered as product of special medicinal purpose, may be continued to be traded as such until the end of transitional period expiring on 1 July 2009. After this transitional period all such products shall have to be reclassified taking into consideration their characteristics (for example, into food supplements or pharmaceutical product) and, if any, regulatory approval procedures performed.
Secondly, the amendments to the Pharmacy Law also concern implementation of the provisions of the EU legislation in relation to medicinal products of progressive therapy for specific patients. Amendment comes into force on 1 July 2009.
Prior to amendment, the Lithuanian laws did not provide for a possibility to manufacture medicinal products of progressive therapy for specific patients without holding manufacturing license.
The adopted amendment grants such right to legal entities having the licence for individual health care protection and the permit issued by the State Medicines Control Service.
The medicinal products of advanced therapy for specific patients may be manufactured and used under doctor’s assignment only in the Republic of Lithuania after the doctor takes professional liability for their prescription and use.
The implementing legislation setting quality standards of such medicinal products, the security, traceability, requirements of pharmacovigilance and the procedure for issuing permits for production has to be drafted and approved by 1 July 2009.
On 26 January 2007 the Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use (the “Paediatric Regulation”) entered into force.
1. Introduction to the Paediatric Regulation
a) The scope
Although the Paediatric Regulation is ostensibly related to medicinal products for paediatric use, the Paediatric Regulation is in fact relevant to medicinal products in general. The Paediatric Regulation also relates to both authorised and unauthorised medicinal products, irrespective of whether they are covered by intellectual property rights.
As of July 26, 2008, data on the paediatric use of a medicinal product from an agreed paediatric investigation plan (a so-called “PIP”) must be provided at the time of applying for a marketing authorisation in respect of any medicinal product that has not previously received marketing authorisation in the EU. The requirement to include data from a PIP may, however, be waived for medicines unlikely to benefit children.
As of January 26, 2009, data on the paediatric use of a medicinal product from a PIP must be provided at the time of applying to vary or to extend an existing marketing authorisation to any new indication, pharmaceutical form or route of administration. The data must cover both existing and new indications, pharmaceutical forms and routes of administration. This requirement applies to authorised medicinal products which are protected by an SPC, or by a patent which qualifies for the grant of an SPC.
b) Rewards
Provided that the product has been authorised in all member states and relevant information regarding the results from the paediatric studies are included in the marketing authorization documents, the relevant medicinal products is entitled to a six month SPC extension.
2. Experiences from the practical application of the Paediatric Regulation
a) What documents should be provided in the application and when?
A patent or SPC holder that have performed paediatric studies in accordance with the Paediatric Regulation has experienced that there are certain practical hurdles inherent in the process for obtaining the six month extension of the SPC. Two questions that have been subject to discussion are what documents should be provided in the application for an SPC extension and when those documents should be provided?
Articles 28.3 and 36.2 in the Paediatric Regulation provides that, in summary, if the marketing authorization application to the competent authority (i.e. the relevant medicinal product authority) complies with all the measures contained in the agreed and completed PIP, and the summary of product characteristics reflects the results of studies conducted in compliance with the PIP, the competent authority shall include within the marketing authorisation a statement indicating compliance of the application with the PIP (not to be confused with the compliance statement issued by the EMEA Paediatric Committee following completion of the paediatric investigation.).
During the five years following the entry into force of the Paediatric Regulation (i.e. until 26 January 2012) the application for an extension of the duration of a SPC already granted shall be lodged no later than six months before the expiry of the certificate. After 26 January 2012 the application shall be lodged no later than two years before the expiry of the certificate.
b) The British Patent Office
The British Patent Office has, as one of the first authorities in the European Union, rendered a decision addressing now discussed issues1. In the British case the applicant had attached to the application the compliance statement issued by the EMEA Paediatric Committee in accordance with the procedure laid out in the Paediatric Regulation. The British Patent Office interpreted “the competent authority” in article 28.3 of the Paediatric Regulation as either the European Commission who issues MAs for EU (if the product has been approved under the centralized procedure) or the national authorities that issues MAs in each member state. Thus, the British Patent Office concluded that the compliance statement issued by the EMEA Paediatric Committee did not meet the requirements in article 8 (1)(d)(i). The British Patent Office also held that updated marketing authorizations according to the Paediatric Regulation is required in all member states before a reward in terms of an extension of the duration of an SPC can be issued.
As far as we have been able to determine the decision now referred to by the British Patent Office has been appealed.
In summary it can be concluded that the decision by the British Patent Office implies that it is not sufficient that the studies are completed in accordance with the approved PIP and that the patent or SPC holder receives a compliance statement from the EMEA Paediatric Committee. It is also required that the compliance statement is inserted in updated market authorizations in all member states. This applies irrespective of whether the studies lead to a new approved indication or not.
c) The Swedish Patent Office
In Sweden it is the Medical Product Agency that grants marketing authorizations while the Swedish Patent Office (“PRV”) grants the extensions of the duration of the SPC.
PRV has recently issued guidelines for how the Paediatric Regulation which on the issues now addressed reflect the decision by the British Patent Office.
PRV´s guidelines state that if the application for extension of duration of a SPC does not meet the requirements in article 8 in the SPC Regulation, the applicant shall be ordered to supplement the application with the missing parts within three months time. PRV has however expressly stated that the fact that one or several medical product agencies have not yet updated the marketing authorization does not entitle the applicant to such a right supplement the application after filing. Consequently, if the marketing authorizations have not been updated in all member states to include the necessary compliance statement before the filing date, the guidelines provide that PRV will not grant any extension of the SPC.
The Paediatric Regulation and the issues now discussed relating to the right to an extension of SPC are of great practical and economical importance for SPC and patent holder, and it can therefore be expected that future decision on theses issues by the PRV will be challenged if PRV implements the policies expressed in its recent guidelines.
On 20 February, 2009, the Swedish Government submitted its bill on deregulation of the pharmacy market to the Parliament. Compared to the proposal submitted for review by the Legislative Council in December 2008, the final bill contained no significant changes.
In short, the proposed deregulation of the Swedish retail monopoly for pharmaceuticals entails that the exclusive right for the state owned Apoteket AB to conduct retail sale of pharmaceuticals to consumers will cease. The monopoly will be replaced by a system where persons and legal entities approved by the Medicinal Products Agency (“MPA”) are authorised to conduct retail sales of pharmaceuticals. In order to obtain such approval, certain prerequisites have to be fulfilled, such as a requirement to supply all pharmaceuticals subject to the reimbursement system and to provide medicinal consultation by pharmacists.
It is emphasised that the deregulation aims, through increased competition on equal terms, at improving the availability of pharmaceuticals, service to the consumers as well as effective use of pharmaceuticals.
Following deregulation, a slight majority of the existing pharmacies will still be state owned (although the state will allow employees to become co-owners of almost half of those pharmacies), whereas the remainder will be sold to private parties to ensure its independence from the Government. It has been indicated that it will become known in the beginning of May which pharmacies will be divested and that the divestment will be effected after the summer.
One of the major questions during the deregulation process has been the new pricing model intended to make it profitable for pharmacy owners whilst maintaining a pressure on prices on pharmaceutical products. The Government bill proposes that the Swedish Dental and Pharmaceutical Benefits Agency (“TLV”) will set the pharmacy purchase price (“PPP”) and the pharmacy selling price (“PSP”) for reimbursed pharmaceuticals (primarily Rx pharmaceuticals but to some extent also OTC pharmaceuticals). The rules on generic substitution (of off-patent reimbursed pharmaceuticals) will be expanded such that the pharmacies will be obligated to replace the prescribed pharmaceutical with the substitutable pharmaceutical having the lowest established price available in the market (not as now, the cheapest pharmaceutical available at the pharmacy). Reimbursed pharmaceuticals which are not subject to substitution (due to patent protection or since there is not substitutable alternative) may be purchased by the pharmacies at a price below the PPP set by the TLV. Parallel imported reimbursed pharmaceuticals which are not subject to generic substitution may be purchased and sold by the pharmacies at prices lower than the PPP and the PSP set by the TLV.
Pharmacies will be free to negotiate its PPP and to determine its PSP on OTC pharmaceuticals and retain the resulting margin.
The Government bill has been examined and approved by the parliamentary committee and the voting in the Parliament is scheduled to take place at the beginning of May, leaving approximately two months until the new legislation is proposed to enter into force on 1 July 2009.
Our Members:
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Kathleen M. Dwyer
conférence bleue
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Germany
Tel.: +49-8177-997481
Fax: +49-8177-997482
Email: conf.bleue@t-online.de
Disclaimer:
This Newsletter is intended to provide general information on the members of conférence bleue and on recent developments of relevance to the pharmaceutical sector. The information and opinions which it contains are not intended to provide legal advice, and should not be treated as a substitute for specific advice concerning particular situations.
Imprint:
conférence bleue
Kathleen M. Dwyer
Managing Director
Headquarters; Widenmayerstrasse 29, D-80538 Munich | Administrative / Postal Address: Weilbachweg 17, D-82541 Muensing
Email: conf.bleue@t-online.de | URL: www.conference-bleue.com
Tel. +49 8177 997481 | Fax: +49 8177 997482