The bird flu: the provision and commercialization of Tamiflu under EC and international law

Publié le 18/11/2005 par Paul Van den Bulck, Michel De Puydt

At this moment, several sources report the fast growing and international spreading of the bird flu (avian influenza). Recent news has in particular confirmed that this virus has reached the frontiers of the European Community, and even has penetrated within this territory via the UK. It is well known that Tamiflu is the medication that…

At this moment, several sources report the fast growing and international spreading of the bird flu (avian influenza). Recent news has in particular confirmed that this virus has reached the frontiers of the European Community, and even has penetrated within this territory via the UK.

It is well known that Tamiflu is the medication that can treat people infected with bird flu. Tamiflu is not a vaccine, as it does not prevent from getting the disease. It is used when the patient becomes infected.

Hereafter we will examine some relevant aspects of the legal framework pertaining to the provision and commercialization of Tamiflu or similar medicines. Firstly we will address the issue of compulsory licensing under patent law, being a mechanism allowing the overriding of existing patent rights on a medicine. Secondly we also discuss the relevant issue of the selling Tamiflu or similar medicines over the internet.

1. Aspects of patent law

The Suisse pharmaceutical company Roche Holding AG owns the monopoly over production and marketing of the Tamiflu drug. The patent on this highly sought after bird flu drug is owned by the US biotech firm Gilead Sciences Inc.

These exclusive rights of Roche and Gilead Sciences are now increasingly challenged, as governments all over the world are confronted with the mounting lack of production capacity by Roche to produce Tamiflu. Indeed, with fears of a global bird flu pandemic increasing, countries around the world have been advised to stockpile the drug, with the result that Roche is said not to be able to fulfill orders for the quantities necessary.

Due to the urgent demand of Tamiflu, comparisons have been drawn with the availability of anti-AIDS drugs in poor countries.

This is important under (international) patent law, as the Aids-crises led to new rules in the World Trade Organisation (WTO) that allow governments to cope with a public health emergency by waiving the patent rights of a private company and allowing the export of the drugs to encounter these public health problems.

Indeed, on 30 August 2003, the WTO members agreed to open up a loophole in the TRIPs Agreement by giving some countries compulsory licensing rights for patented medicines in order to protect the public health within their territory ( for the content of this decision).

All WTO member countries are eligible to import patented medicines under this decision, but 23 developed countries announced voluntarily that they will not use this system to import. A number of other countries announced separately that if they use the system it would only be for emergencies or extremely urgent situations. They are: Hong Kong China, Israel, Korea, Kuwait, Macao China, Mexico, Qatar, Singapore, Chinese Taipei, Turkey and United Arab Emirates.

This means that in principle any WTO member, other than those who have renounced to use the system, may apply for a compulsory license on a patented drug that will help to face a disease threatening the public health of its population.

In this regard, one can note that it has already been frequently suggested that the bird flu, and in particular the medicine Tamiflu, falls within the scope of this new agreement. Therefore, a WTO member would be allowed to apply for a compulsory licensing on the patent of Tamiflu in order to cope with a (possible) human flu pandemic.

Under these new rules, any WTO member seeking to produce an anti-flu drug must first try to reach an agreement with the licence holder. It is reported that Roche said it had received only one request to produce Tamiflu so far, from Taiwan.
Indian drugs maker Cipla, which is also involved in the production of cheaper generic copies of HIV/AIDS drugs under the WTO rules, reportedly has also shown an interest in producing copies of anti-flu drugs.

However, despite the existence of the Agreement since August 2003, WTO members are still discussing on how to implement this political decision in the TRIPs Agreement. Discussion are in particular held with regard to the need to proceed this implementation via a new article, a footnote or otherwise.

Divergent point of views also exists pertaining to the statute of the WTO Presidency declaration preceding the adoption of the August 2003 Agreement (which has a restrictive effect on the August 2003 system). One can hope that the current WTO negotiations on farm issues will result in a favorable climate to find an agreement in this domain of patent law.

In the meanwhile, the European institutions currently discuss a draft regulation that envisages a uniform implementation of the August 2003 Agreement in national legislation of the EC Member States ( for the content of this draft). It is foreseen that the European Council will soon be able to reach an agreement in this regard.

Taking into consideration the current lack of transposition of the WTO political agreement of August 2003 into the TRIPS Agreement and into the national legislations of the WTO members, one can wander into which extent this Agreement is enforceable by countries willing to apply for a compulsory license. It would not be so surprising if also this enforceability will depend on a certain degree of political willingness by some industrialized members…

2. The commercialization of Tamiflu over the internet

In this context, the issue of the selling over the internet of bird flue medicines has to be addressed as well. It is indeed a fact that Tamiflu, as well as other, new or generic bird flue medicines, are currently being sold over the internet and that there are several advertising actions in this regard.

When considering the legal framework of this practice, one may refer to the Deutscher Apothekerverband case of the European Court of Justice (E.C.J., 11 December 2003, Case C-322/01), from which the following can be derived:

1. With regard to medicines that are only available on prescription, the Court of Justice took the view that allowing such medicines to be supplied on receipt of a prescription and without any other control could increase the risk of prescriptions being abused or incorrectly used. Furthermore, the fact that the labeling of a medicinal product may be in a different language can have more harmful consequences in the case of prescription medicines. Consequently, according to the Court, a national prohibition on mail order sales of medicinal products available only on prescription can be justified.
2. In the case of non-prescription medicines, such a prohibition is not justified, since it would be possible that adequate advice and information may be provided. Internet buying may even have certain advantages, such as giving consumers time to think about any questions they may wish to ask the pharmacist from home.

   As the Tamiflu medicine is, according to our knowledge, in most cases only available on prescription, one has to conclude that the EC Member States concerned will be entitled to enjoin the selling of this medicine over the internet in the event this is done without a prescription.

3. EC Member States sometimes prohibit the advertising to the general public of medicinal products, which are available on medical prescription only. In this regard, the Court stated that is not precluded a national prohibition on advertising the sale by mail order of medicinal products which may be supplied only in pharmacies in the Member State concerned, in so far as the prohibition covers medicinal products which are subject to prescription.

   In the present context, this court ruling means that the national courts of the EC- Member States will in principle be permitted to apply a law that forbids the advertising over the internet of the Tamiflu that merely can be supplied by pharmacies.

4. With regard to the commercialization over the internet of new or generic bird flu medicines, one has further to take into account article 6 of Directive 2001/83/EC of on the Community code relating to medicinal products. This article states that no medicinal product may be placed on the market of a Member State unless a marketing authorization has been issued by the competent authorities of that Member State or an authorization has been granted in accordance with Regulation No 2309/93 (i.e. the Community Authorization Procedure).

   This obligation exists in all the EC Member States and is considered as being necessary to ascertain the safety, quality and efficiency of the medicinal products concerned.

   According to Article 18 of this Directive, an authorization granted by a Member State can nevertheless be recognized by another Member State of the European Union, but the latter is not compelled to proceed as such. Therefore, when an internet seller located and obtained an authorization in a particular EC Member State has not registered the medicinal product concerned in another EC Member State, a procedure of mutual recognition can be applied.

   Regarding imports of medicinal products by mail order by pharmacies authorized in other Member States in response to individual orders placed over the internet, the Court of Justice stated in the above mentioned case that, in relation to medicinal products which have not been authorized in a Member State, a general prohibition to commercialize these imported products in the latter is in conformity with the EC law and therefore applicable.

   However, as regards medicinal products, which have been authorized for sale on the market of a Member State, the Court points out that a national prohibition on the sale of medicinal products by mail order is not in conformity with the European Community law and is therefore not allowed.

   Considering this case law, one is permitted to sell a new or generic bird flu medicine over the internet when this product has been authorized. However, the selling will not be allowed the case when this product is sold over the internet into the EC Member State where no authorization has been granted for that product.

   EC Member States, or their courts, are therefore entitled to enjoin the internet sales of said medicinal products without an authorization, this depending on their domestic public health policies. In general, differences in policies indeed exist: for instance, The Netherlands have a more permissive attitude towards the commercialization of medicinal products via the internet, whereas France has a more restrictive approach.

3. Conclusion

It is reported that health professionals are becoming concerned at the H5N1 bird flu strain’s emerging resistance to Tamiflu. Therefore, this and similar drugs might be less useful than anticipated if resistant-strains of the bird flu virus become more prevalent and the virus gains the ability to pass easily from person to person. One can therefore hope that the above said regulations will not hamper the necessary flexibility to face this new complication in combating this virus.