Europe attacking access to affordable generic drugs
Bangkok Post | 24/11/2010
Europe attacking access to affordable generic drugs
Millions of people in developing countries rely on affordable quality generic medicines produced in India to stay alive. In fact, Medecins Sans Frontires (MSF) sources more than 80% of the HIV medicines it uses to treat 160,000 patients across the world from India, and a recent study found that from 2003-2008, more than 80% of donor-funded purchases of HIV medicines came from India.
Children with Aids (above) are looked after at the child care centre in Phnom Penh. Below is a poster distributed by the Vineeta Foundation. Today’s innocent children born with Aids will also be affected by the difficulties associated with accessing vital treatment.
Manufacturers in India have been able to produce cheaper versions of drugs patented elsewhere because until 2005, the country did not grant patents on medicines and multiple producers competed for the market, driving prices for the most-affordable drug combination down by more than 99% over the last decade.
Since 2005, however, patents have been granted on medicines in India, in particular on newer drugs, as ones developed before 1995 do not deserve a patent under India’s pro-public health patent law. The future of access to newer medicines, urgently needed for the treatment of HIV/Aids, is therefore already in question.
Now the European Union is dealing another blow by pushing trade policies upon India through a free trade agreement (FTA) and through the Anti-Counterfeiting Trade Agreement (ACTA) that will both severely restrict the ability of India to remain the key source of affordable medicines in the future.
There is a constant refrain from rich governments, pharmaceutical giants and the business press that developing countries’ intellectual property laws need to change and are unfriendly to business interests. What is talked less about is the consequence of the changes proposed.
Currently, the EU is negotiating an FTA with India in which they are demanding a number of provisions that extend big pharma’s protection from competitors and undermine the careful balance that India has created in its patent and drug registration laws.
One such provision _ the effects of which are little understood _ is the EU’s demand that India introduce a new protection for multinational pharmaceutical companies from normal price competition. It is called "data exclusivity".
Data exclusivity would prevent the Indian drug regulatory authority from granting marketing approval for generic medicines for a period of time that could be up 10 years.
Currently, when a generic manufacturer applies to register another version of an already-registered medicine, they only have to demonstrate that their product is therapeutically equivalent to the original. To fulfil the efficacy and safety requirements, the drug regulatory authority relies on the registration file of the original manufacturer.
But data exclusivity prevents this, by allowing the originator company to keep its registration data private. In practical terms, data exclusivity prevents the registration of generic versions of a medicine for a set period of time, unless the generic manufacturer were to repeat the drug trials that the originator has done, even though such repeat tests are unethical and costly.
The EU claims data exclusivity is required under international law. It is not. It also claims that there will be no harm to access to medicines. But other countries have learned the hard way how harmful it can be.
The EU further claims that any harm will be limited because data exclusivity will be lifted if a compulsory licence is issued. But what they do not say is that data exclusivity will apply even when a medicine would not deserve a patent under India’s strict patent law that prevents companies from getting patents for making minor changes to medicines that have no added therapeutic value.
A second threat to generic medicines that is being aggressively pursued by the EU is ACTA, which has been negotiated in secret. The idea is that once signed, ACTA will be extended to developing countries. One of the justifications for the treaty is that it is needed to fight against the trade in counterfeit medicines. This was the same justification given for the World Trade Organisation’s TRIPS agreement which developing countries have already agreed to.
But unlike TRIPS, ACTA does not contain protections against abuse by companies and indeed encourages overzealous enforcement.
In a windfall to big pharma, ACTA will use public money to enforce private rights. It widens the enforcement net so that legitimate medicines could be detained in transit or destroyed simply because their label looked similar to the originator product (commercial trademark infringement). This has nothing to do with protecting the public from fake medicines, and limits the courts’ ability to balance public health and profits.
On a mere allegation and not proof, including by a competitor, generic suppliers allegedly infringing a patent or a trademark may face the delay or destruction of goods, disproportionate damages, potential bankruptcy, and in some cases, even criminal proceedings.
And by extending liability to third parties, ACTA puts suppliers of active pharmaceutical ingredients used for producing generic medicines; distributors and retailers who stock generic medicines; non-governmental organisations such as MSF who provide treatment; funders who support health programmes; and drug regulatory authorities who examine medicines, at risk of injunctions, provisional measures, and even criminal penalties, including imprisonment and severe economic losses.
This could act as a significant deterrent to anyone involved in the production, sale or distribution of affordable generic medicines.
Even the United States is opposing a number of the provisions that the EU refuses to back down on, such as the inclusion of patents in the agreement and the increasing of the scope beyond wilful trademark infringement.
The spectre of harmful fake medicines is one of the concerns used to justify ACTA. Yet ACTA’s real purpose is not designed to deal with fraudulent, unsafe, and ineffective medicines; its purpose is to protect the commercial interests of multi-national companies.
Action against unsafe medicines requires a global solution developed through a legitimate process, in which all countries are involved. Developing countries have asked that such discussions take place at the World Health Organisation and other multilateral institutions rather than amongst a few countries, behind closed doors.
The sad truth is that ACTA would inhibit generic competition and increase drug prices, which actually incentivises the introduction of counterfeit medicines _ WHO has recognised that high drug prices are a cause of counterfeit medicines: patients demand low-cost alternatives, and counterfeiters respond.The EU claims it wants to safeguard access to medicines in developing countries. Unless the EU-India FTA and ACTA are changed to remove the threat to such access, these are empty words.
Paul Cawthorne is an officer on the Access to Essential Medicines Campaign, Medecins Sans Frontires.
