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Pharmaceuticals: European Regulatory Clearance

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OLYMPUS DIGITAL CAMERAToday on IPcopy we have a guest post from Rob Jacob of Stephenson Harwood LLP on the subject of pharmaceutical name approvals.

Choosing a name for a prescription pharmaceutical product is not an easy task. You need a name that sets your product aside from the competition, something catchy, something memorable and most importantly something management and marketing believe in and can use to sell to the market – by no means an easy task. However, choosing such a name is not the end of the story. In fact, it is just the beginning. Getting a pharmaceutical name approved by both legal and the regulators is where the task really begins. The rules and regulations surrounding the clearance of pharmaceutical names are complex and fraught with hurdles that must be overcome.

Legal clearance is about ensuring that your proposed brand does not infringe a third party’s trade mark. Regulatory clearance is completely different and is the focus of this entry. Whilst this brief entry can’t do the topic justice, it will hopefully act as an introduction to the issues involved.

The regulators are not specifically interested in whether there are earlier trade mark registrations. They are concerned with patient safety. They compare your chosen mark to other pharmaceutical products that are actually available on the relevant market (or recently discontinued) and will consider whether there is a risk of substitution errors occurring resulting in the patient taking the wrong product. The regulators will give more weight to the busy environment in which products are typically prescribed (busy and noisy hospitals, doctor’s illegible handwriting) and also whether there are similarities between the therapeutic indications, form, and method of use of the pharmaceuticals being compared. The fact that the earlier product is sold in a tablet form and your product is sold in solution may therefore be an important distinguishing factor. This typically would not be a consideration from a legal clearance perspective.

A popular example cited by the regulators is the real life instance when Coumadin was dispensed instead of Avandia which the doctor had prescribed by way of a handwritten script:

GP sig

Whilst Coumadin would not block Avandia from a legal clearance perspective, the regulators may still have safety concerns. A doctor’s scrawl penned in a hurry can bring two names that on first inspection don’t appear similar much closer together. Both Avandia and Coumadin are available in 2 and 4mg tablets and both are normally taken ‘once daily’. Accordingly, there is a real risk that once dispensed patients could mistake one for the other. Coumadin is an anticoagulant which thins the blood – not what you would want to happen were you suffering from diabetes where your blood sugar levels are already dangerously low. Avandia is a diabetic. The safety concerns resulting from a dispensing error are therefore treated very seriously by the regulators.

Another factor which the regulators will consider is whether the name has any positive or negative connotations. For example, the regulators would not like names that elude to words such as heaven, bon, solve, miracle, poison, death, demise or doom. Likewise, the chosen name should not encourage or discourage patients to take your product. It also should not infer incorrect methods of taking the product (e.g. ‘take 5’ when only one should be taken or ‘after eight’ when it should be taken at lunchtime, etc.). Linguistics in each key territory therefore also need to be considered. A name that has no negative connotations in English may have a completely different meaning in Spanish or Slovakian.

You can apply for approval on a country by country basis or on a European-wide basis (via the European Medicines Agency (“EMEA“)). Currently, it is possible to submit up to 4 names to EMEA. However, this is shortly reducing to two, which means searching will become even more important. Typically, if budget allows,  companies should consider at least 10-15 different brands from the outset and put them through regulatory and legal clearance searching in an attempt to get at least one approved. Ideally you should be submitting possible names to regulators 6 months prior to your submission for marketing authorisation. Apply too early and there is a danger that a new drug will enter the market which is too similar to your preferred names resulting in your name being blocked. Apply too late and you may not have time to submit alternative names if your preferred names are rejected and you would have to launch your product under the generic name – Not an attractive prospect.

European approval is harder to achieve because you need to satisfy the regulators that there are no safety concerns in any European country and in all European languages. The European route is compulsory for medicines for HIV/AIDS, oncology, diabetes, neurodegenerative and viral diseases along with orphan medicines (medicines used to treat rare diseases). Applying at a national level is more expensive but it means that different brands and labels can be used in different European countries and a safety concern in one European country does not prevent you using the brand in the remaining European countries. Conversely, if you apply via the centralised route at EMEA, the same brand and label must be used throughout Europe and a safety concern in one European country results in complete refusal throughout Europe.

Full regulatory and legal clearance searches can get expensive, for example, it is possible to carry out full linguistic and name safety testing (showing the name to doctors and pharmacists to obtain their reaction). Generally speaking, the more detailed the searches you carry out the smaller the risk that your mark will be unexpectedly refused. This risk can’t however be completely eliminated. The regulatory process is confidential and there could always be a third party application which trumps your chosen name. Costs can be reduced by staggering searches on a country by country basis (starting with the most important countries) so that any issue in a ‘phase 1’ country will eliminate the name without going to the expense of searching in all countries of interest.

This blog entry summarises some key strategic decisions to be made in considering how to most cost effectively clear a name in time for launch. These are often finely balanced and practical experience of the process is invaluable.

Rob Jacob   15 April 2014

Stephenson Harwood LLP




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