IHS Global Insight Perspective | |
Significance | The Norwegian Association of Pharmaceutical Manufacturers has called for European authorities to investigate the systematic delays in marketing authorisation application processing times imposed by the national Medicines Agency, which according to the industry association are in breach of European laws. |
Implications | The lengthy case handling times delay market access for innovative drugs, which result in revenue shortfalls for the industry and non-access to innovative treatments for patients. The problem extends to marketed medicines for which delays in renewing marketing authorisations can result in the drug being withdrawn from sale, again resulting in lost revenues for the industry and lack of usual treatment for patients. |
Outlook | The European authorities are likely to look into the allegations as the delays were qualified as "systematic". If Norway improved efficiency in licensing of medicines, it would make a wider number of innovative medicines available in the country. This would automatically weigh on the country's healthcare budget and Norway could soon be looking at further cost-containment measures. In a country that has taken little notice of cases of intellectual property rights in the past, this could be bad news for the industry. |
The Norwegian Association of Pharmaceutical Manufacturers (Legemiddelindustriforeningen, LMI) has called, through legal channels, for the European Free Trade Association (EFTA) Surveillance Authority to investigate the Norwegian Medicines Agency's (NOMA) medicine licensing procedures. More specifically, the LMI accuses the NOMA of not complying with European Economic Area (EEA) rules by systematically failing to meet the case handling time limits set out by Community legislation. The documents, drawn by law firm Schjoedt and made public by the LMI, underline that:
- In the case of pharmaceutical marketing authorisations under the National Procedure, the NOMA issues response letters stating that the agency "cannot estimate when individual applications will receive national authorisation". European directive 2001/83 article 17 sets at 210 days from the time of application submission the time limit allocated to national medicines agencies to complete their review;
- In the case of pharmaceutical marketing authorisations under the European Mutual Recognition Procedure (MRP) and where Norway does not act as the Reference Member State (RMS), the NOMA issues response letters stating that "the time for the procedure is an average 220 days as per 15 September 2008". Under European directive 2001/83 article 28, the time limit for the NOMA to make a decision on the marketing authorisation application is 120 days;
- In the case of pharmaceutical marketing authorisations under the European Decentralised Procedure (DCP) and where Norway does not act as the RMS, the NOMA issues response letters stating that "the time for the procedure is an average 170 days as per 15 September 2008". Under European directive 2001/83 article 28, the time limit for the NOMA to make a decision on the marketing authorisation application is 120 days;
- In the case of submissions for renewal of marketing authorisations, the NOMA can take from 2 to 3 years to evaluate the application. European directive 2001/83 article 24 sets a maximum time limit of 6 months, although the documents underline that Norway has failed to include this provision into national law;
- In the case of submissions for variations of marketing authorisations, the NOMA usually takes 18 months to evaluate the application. Under European directive 2003/1084, the NOMA has 14 to 90 days to reach a decision, depending on the type of variation at hand.
Furthermore, the documents draw attention to European Court of Justice (ECJ) judgement in case C-452/08 Synthon, which according to lawyers at Schjoedt "indicates that only public health grounds may justify a delay". The documents conclude that the "infringements of EEA law by the Norwegian authorities are manifest" and call for EFTA to investigate the matter further.
Outlook and Implications
A direct consequence of the NOMA's lengthy processing times is market access delays for pharmaceutical manufacturers, which result in revenue losses, and delayed access to innovative medicines for patients. Moreover, the extent of the delays may deter pharmaceutical companies from seeking marketing authorisation in Norway in light of the time-line uncertainty. The documents also highlight that the delays are an obstacle to the implementation of a common Nordic package and could at worse result in a product never being sold onto the Norwegian market, again at the patient and manufacturer's detriment. The consequences of the delays also pose problems to manufacturers of marketed medicines as commercialising a product without the proper documentation is illegal. If manufacturers abide by national laws, the NOMA's failure to process applications for marketing authorisation renewals within deadlines can cause the discontinuation of a product on the Norwegian market, which again affects both patients and manufacturers. The NOMA's failure to process applications for marketing authorisation variations can have similar consequences. Furthermore, patient safety and availability of treatment are affected by the fact that summaries of product characteristics (SPCs) are not updated in a timely manner.
The NOMA is not the only regulatory agency to suffer delays (see Denmark: 5 March 2009: Danish Medicines Agency Publishes H1 Targets for Medicine Licensing). Nevertheless, its systematic failure to meet legal targets is what is prompting the present action. Interestingly, the NOMA has not taken significant steps to improve the situation. Whether the delays are a way to contain the country's expenditure on innovative medicines are anyone's guess. Norway implements a raft of aggressive cost-containment measures when it comes to pharmaceutical expenditure and its drug prices in the country are amongst the lowest in Europe. Price erosion in the country is steep and the Norwegian pharmaceutical market grows well below the European average (see Norway: 25 November 2008: Norwegian Pharmacy Association Provides Price-Erosion Snapshot on Best-Selling Medicines and Norway: 17 February 2009: Norway Expands Step-Price System as Pharmacy Association Publishes Detailed Figures for 2008 Ambulatory Market).
An investigation into the NOMA's practices could force the agency to step up its game, which would make innovative pharmaceuticals more widely available in the country. This would have a direct impact on the country's drug bill and the Norwegian government could as a result be looking into further cost-containment measures. One area of concern for the pharmaceutical industry is that of intellectual property rights as Norway has already been criticised in a report by the United States Trade Representative (USTR) for non-compliance with those of the innovative industry. Norway was since placed onto the U.S. Special 301 report watch list and could have little to lose should the country decide to go down this avenue to contain its drug bill.