The European Court of Justice (ECJ) has handed Shire Plc and Janssen-Cilag Ltd, a Johnson & Johnson (J&J) company, a victory against Generics [UK] Ltd in a case involving the Alzheimer's treatment Reminyl. The court's ruling is in line with the rejection of Generics UK’s marketing authorisation for a form of galantamine by the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA decision was based in part on an attempt by the generic-drug maker to reference a drug approved in Austria in 1963. The marketing authorisation for Nivalin (galantamine), the drug Generics UK referenced, was not updated after Austria joined the EU to comply with European Community law and cannot be used as a reference product. Nivalin was sold by Waldheim Pharmazeutika, which had approval to market the drug as a treatment for polio until 2001. Janssen-Cilag entered into an agreement with Waldheim to gain marketing authorisation for galantamine in 2000, to be sold under the brand Reminyl for Alzheimer's disease.
The agencies of Estonia, Iceland and Liechtenstein said either that they had agreed no transitional period with the Commission or did not require one. Ms Margit Plakso of the Estonian agency said that all products that were not authorised in accordance with EU by 2004 were removed from the market. Both Ireland and Malta enjoyed transitional period agreements with the Commission and have since removed all products from the market that do not comply with EU legislation. The other Member States have not reassured that this is the case.
As reported by Mr Faraz Kermani in Scrip, the case has put the calculation of data exclusivity periods into the spotlight in the EU and has come as a welcome relief for pharmaceutical originators. The outcome was that it increases the pressure on Member States to remove non-authorised products from the market. The conflicting interpretation of the length of data exclusivity is what makes this case interesting.
The data exclusivity period is calculated on the basis of first filing for a marketing authorisation. The rules on data exclusivity have been harmonised by legislation that was adopted in 2004 and came into effect towards the end of 2005. Prior to this, the old regulatory data exclusivity protection period must be taken into account. Under this regime, for products subject to central authorisation, 10 years exclusivity was granted, and for products approved nationally either six or 10 years is applicable, depending upon the jurisdiction.
In terms of nationally authorised products, the ‘10-year countries’ include: Belgium, Germany, France, Italy, Luxembourg, The Netherlands, Sweden and the UK. The ‘six-year countries’ are: Austria, Denmark, Finland, Greece, Iceland, Ireland, Norway, Portugal and Spain, and the 12 newest Member States. To a large extent, it is the countries that have traditionally been havens for pharmaceutical innovation that opted for the 10-year protection period, whereas those that have encouraged the faster entry of generics into the market fall into the six-year group.
Mr Grant Castle, a partner at law firm Covington & Burling, who led the case for Shire and J&J subsidiary Janssen-Cilag, pointed out that whilst the MHRA was backed by the two originator companies, the government of Poland was strongly on the side of Generics UK.
Generics UK argued that the data exclusivity period for its proposed reference product, Nivalin – nationally authorised in Austria in 1963 – should have begun on the date when Austria acceded to the EU, meaning it would have expired in 2001.
However, when applying for a marketing authorisation in the UK for Nivalin, Generics UK had also made reference to another galantamine-based product called Reminyl. Janssen-Cilag AB gained approval for Reminyl from the Swedish competent authorities for the treatment of Alzheimer’s disease on 1 March 2000. In the UK, Shire Plc has been the holder of a marketing authorisation for Reminyl since 14 September 2000.
This is where the matter gets even more complex. Having first dismissed the idea that the Austrian authorisation for Nivalin was in fact in line with Community law, Janssen-Cilag and Shire then said that if the marketing authorisation was linked to Reminyl, then the data exclusivity period should be calculated from the date of its first approval in the EU, namely in Sweden. On this basis, it should therefore expire, after a 10-year period, in March 2010.
The ECJ accepted almost without question J&J’s and Shire’s arguments related to the incompatibility of the Austrian-authorised Nivalin with EU marketing application authorisation rules. As such, it refuted the argument put forward by Generics UK that the data exclusivity period for the reference, galantamine-based, product had expired in 2001. By rejecting the claim that Nivalin was properly authorised, the Court had no need to address the claim by the originator companies that the real expiry date would be in 2010.
But given that Generics UK’s arguments all seem tenuous at best, why was the case ever brought before Europe’s highest court? It appears that there are a multitude of potential reference products floating around Europe following the recent accession of new Member States to the EU. Essentially the Nivalin case was a test case for the generics industry. If it had been successful here, then it may have been able to piggy-back new products on reference products that still remained on the market in countries such as Lithuania and Poland, but were never authorised in accordance with EU law.
It is possible to claim that these drugs might be relatively safe, given that they have been in use and on the market in their respective countries for a number of years. However, they have been placed on the market with relatively little data and therefore it is perhaps more problematic to suggest that a generic version of such a drug, based on the restricted data, could be as safe. Indeed, generic companies that attempted to use this method of authorisation may in the future have found themselves to be in severe difficulties both ethically and legally where a drug has not performed as it should.
Legally, the onus is on the accession Member States to ensure that any drugs that do not conform to EU regulations do not remain on the market. However, it is also possible for them to have negotiated transitional arrangements with the Commission for these products. There is a suspicion that a Member State that has done neither is failing to act on grounds of protectionism.
For example, suppose a company has successfully and safely been selling its product on a national market for decades, and then following a political intervention at international level its product either has to be removed from the market or undergo a series of tests that could also result in its withdrawal. Would a national government from a newer Member State be automatically willing to see that product disappear? Such countries have a need for cheaper drugs, many domestically generated and therefore widely recognised. Their removal could not only have budgetary implications, but could cause confusion amongst patients.
What is more, the upgrading of such products and their dossiers to comply with EU regulations places an increased work burden on both companies and competent authorities.
The agencies of Estonia, Iceland and Liechtenstein said either that they had agreed no transitional period with the Commission or did not require one. Ms Margit Plakso of the Estonian agency said that all products that were not authorised in accordance with EU by 2004 were removed from the market. Both Ireland and Malta enjoyed transitional period agreements with the Commission and have since removed all products from the market that do not comply with EU legislation. The other Member States have not reassured that this is the case.
Source: BusinessWeek, Scrip
2
Post your comment