Medicines Council’s fears turn to tears

EYE CARE: HIGH COURT RULES DROPS ARE MEDICAL ‘DEVICES’

Expert’s testimony was ‘hypothetical and speculative’.

Aglobal pharmaceutical company has won its battle against the Medicines Control Council (MCC) to have its range of eye drops declared medical devices, and not medicines subject to government regulation, by the North Gauteng High Court.

Judge Mabel Jansen granted an order to Allergen Pharmaceuticals that its Optive range of “opthalmic lubricants” were medical devices and therefore did not have to be registered.

The director-general of the national health department had repeatedly seized shipments of Allergen products as unregistered medicines.

The high court ruled last year medical devices did not have to be regulated by the MCC, pending the promulgation of medical device regulations.

The council insisted it was acting in the interests of public safety, even though similar products of Allergen’s competitors were available on the market.

Artificial tear solutions and contact lens solutions have to be registered in South Africa. Allergen maintained its products had been registered as medical devices and not medicines in numerous countries worldwide.

Its products were recognised globally as ophthalmic medical devices, as opposed to artificial tears – the only eye care product subject to registration as a medicine in terms of the Medicines Act, they argued.

The MCC opposed the application, insisting the Optive products were medicines.

Judge Jansen severely criticised the “sweeping conclusions” of the MCC’s expert Dr Andre Walubo as hypothetical, speculative and based on the research of others and a misunderstanding of the definition of a medical device.

“Effectively what Dr Walubo seems to do is to seek for fragments of evidence which might indicate that the ingredients of the Optive range .... may have some other effect than that claimed by the applicant.

“...Dr Walubo seeks to contend that all the benchmark countries, who are specialists in their field, are wrong in classifying the Optive range as medical devices,” she said.