Global Insight Perspective | |
Significance | The lack of improvement in waiting times for approval filing for generics under the Decentralised Procedure (DCP) and Mutual Recognition Procedure (MRP) in the European Union (EU) and new patent linkage threats continue to dominate the EGA agenda. |
Implications | There are signs that improvements are within reach; at least on the approval filings side, as France and some of the newer EU members are preparing to take on a higher share of DCP and MRP filings as a reference member-state (RMS). However, even on this front there is still a lot to be done. |
Outlook | Until approval resources are boosted at the member-state level and a degree of flexibility is injected into the current 'slot' system, double bookings are likely to remain a fact of life for generics manufacturers. In the short-term, the EGA is boosting efforts to educate the European Patent Office (EPO) and the judiciary at country level about the barriers to generics entry that current deficiencies in the patent review process can create. |
EGA Highlights Patent Linkage Concerns …
Market entry delays for generic copies of pharmaceuticals promise to become more severe unless the recent cases of patent linkage in some European countries are urgently addressed, European Generics Association (EGA) Director-General Greg Perry stated at the opening of the EGA's recent annual meeting.
Patent linkage |
Patent linkage is the practice of linking either market approval, the pricing and reimbursement status, or any regulatory approval for a generic medicine to the patent status of the originator reference product. |
Source: EGA. |
Patent linkage is not part of the current pharmaceutical regulations at the European Union (EU) level; however, some aspects of existing Bolar-provision regulations have left room for confusion and misinterpretation due to the vague terminology and divergent implementation in member-states. Current Bolar provisions state that generics companies should be allowed to start pre-market testing of medicines before the originator's patent expiry and that such tests and "the consequential practical requirements shall not be regarded as contrary to patent rights." Interpretations of "consequential practical requirements" vary from country to country (and often form region to region within the same country), creating windows of opportunity for so-called 'patent linkage'.
The year 2007 saw the resolution of a patent-linkage challenge to the generics industry in Sweden. However, in 2008 patent-linkage issues continued to persist in Portugal. Recent court decisions in cases triggered by the originator companies have scared the Ministry of Economic Affairs in Portugal so much that the agency has stopped granting price approval to generics involved in the 17 ongoing court cases. The result is that no major generics have come in the Portuguese market since July 2007. "Our fear is that it could spread to other countries," Perry said.
Patent linkage is highlighted as one of the key market entry barriers for generics in the new EGA report "Patent-related Barriers to Market Entry for Generic Medicines in the European Union," released last week. Along with patent linkage, the EGA identifies specific deficiencies in the patent review system at the EU level, originators' practice of creating patent thickets and follow-on patents and patent-litigation procedures at the member-state level as key problems for the generics industry. The report is intended to educate the European Patent Office and judges at country level about the need to pay specific attention to some of the tactics used by originator companies to delay generic competition. The potential for abuse of the Supplementary Protections Certificates (SPCs) system has also been illustrated in a case where the branded manufacturer obtained an improper SPC after providing an incorrect marketing approval date to the EPO. The EGA report recommends that in order to avoid such cases in future, originator companies should be required to provide a sworn statement and documentary evidence of the first European marketing approval of the product when applying for an SPC.
… as Filing Delays Persist
Aside from patent issues, the EGA has not seen improvement in waiting times for generics filing slots for approval under the DCP and MRP. Companies are now filing for approval application slots in 2010, with an average delay of two to three years depending on the therapeutic class. The EGA's proposal for the creation of a centralised database with available filing slots has not been welcomed, according to EGA Director of Regulatory Affairs Beata Stepniewska. However, a sub working-group was set up at the Heads of Agency meeting last April to address the slots delay issues.
The top five Reference Member-States (RMSs) for generics approval filings—Germany, Denmark, the United Kingdom, the Netherlands and Sweden—reviewed 240 generics application on average in 2007. The concern is that other member-states are not dedicating sufficient resources to the European review process of generics and the top five are struggling with demand. France, at least, will boost its roles as an RMS. Jean Marimbert, Director-General of France's drug-approval agency, AFSSAPS, announced at the meeting that France plans to initiate 50 generics approval procedures under DCP or MRP in 2008, up from 32 in 2007. The country will also reduce parallel full assessment in MRP/DCP and rely more on the assessment of other RMS, according to Marimbert.
Outlook and Implications
In addition to France, other members of the EU—particularly some of the newer member-states—are expected to take a more active role in generics reviews under the DCP and MRP. Romania is expected to start acting as an RMS next year and Poland, whose drug-approval agency certainly has the capacity to take on European reviews, is also expected to take an active part after clearing its internal generics re-registration backlog by the 31 December 2008 deadline.
As the ability and willingness of additional EU member-states to act as an RMS in generics reviews, the waiting times for an application slot should shorten. However, this is not expected to happen until the medium-to-long term. In the short term, the EGA will focus on proposing measures that would reduce the problem with double-booking for filing slots. Introducing a measure of flexibility—defined by Perry as a two-month window of opportunity to reschedule a filing slot if for some reason the generics company fails to collect all the necessary data for filing on time—could go a long way towards reducing double bookings. The EGA estimates that if the waiting time for filing slots is cut to six months rather than current wait of two or three years, generics companies will be able to estimate accurately their readiness for a submission—and would not need to double-book a filing slot as a safeguard.
The patent-linkage problem is significantly more complex. As pricing and reimbursement or substitution decisions are a national competence rather than an EU one, the European Commission would not get involved in patent-linkage cases unless there is a pattern of anti-competitive behaviour. That said, Perry is optimistic that the patent-linkage barriers for generics entry would significantly improve under the new French presidency of the European Commission. The obvious solution is to include a statement in EU regulations that patent linkage is illegal. However, the chances of that happening—given the strong originator industry lobby and pressure from the United States—are slim for the foreseeable future.