Tag Archive | TRIPS

Government stirs on intellectual property plans

New approach to SA intellectual property 

……sent to clients Aug 1trademark logo6…. The Cabinet has agreed that a new intellectual property (IP) framework is needed and has asked that discussions commence with all stakeholders in order to set out a future IP policy for South Africa.

In 2013 the South African government released a draft IP policy which ran
into heavy weather because of ambiguities and anomalies at law. This previous attempt was rejected by Parliament.

dti-logo2Since that time, the private sector has complained of no movement from the Department of Trade and Industry (DTI) on the subject, or even the Department of Justice and Constitutional Affairs.

Hidden agendas?

Suspicions existed that a lot more was written “between the lines” by DTI in the light of a feeling that government medical authorities, including the Minister of Health and a large number of public sector entities, were favouring the case for making it easier for generics to come on to the market in view of the wish to introduce national health insurance and cheaper medicines.

copyright graphicThe law courts, always sticklers in their respect for the international word of law, favoured, it seemed, external legal international precedent as the basis for a new approach.

Discussions with DTI surrounded their attitudes and their not so transparent views on the Trade-related Aspects of Intellectual Property Rights agreement (TRIPS). However, that approach may have altered with DTI now more openly favouring Bi-lateral Trade Agreements (BITs).

Bad influence

In 2014, the whole question of IP policy became mired in controversy with a statement from a US-based lobby group based from Washington who surprised all by stating they were working with the local pharmaceutical
industry to influence the SA government and also the Department of Health (DOH) in particular in order to gain more ear to the international view. This was subsequently denied by the pharmaceutical world in SA (IPASA).

The whole matter appeared to inflame the incumbent Minister of Health, Dr Aaron Motsoaledi, who will no doubt be a key player in the new discussions.
After this the 2013 proposals seemed to fall away. Parliamentary hearings were at the time controversial, to say the least.

The major complaints boiled down to the fact that there were no time frames in the government proposals; no regulatory impact assessment had been done; and there was no appearance of a follow through of the effect of the Bill on international commercial ties.

Expert patent lawyers complained of ambiguity and lack of clarity at law.

Where it stood

After some heated debates at the time it appears that TRIPS, despite BITs copyright symboleven then being a new DTI “hobby horse”, has been respected by DTI and the generalised view accepted by most that there would be compulsory local patent registration based on a localised validity acceptance and acceptance by a localised body of all medicines dispensed. The query remained, however, on the skills available to undertake such a policy and time lags.

Whether the originally proposed patents tribunal will have final say in dispute or the High Court of SA will no doubt now be debated, as well as the critical issue of the length and duration of registered patents in a transparent manner with experts and a broad based body to represent the private sector.
As before, probably a “workshop” will be called for to air views.
Previous articles on category subject
Impasse on intellectual property rights – ParlyReportSA
Intellectual property law still in limbo – ParlyReportSA
Intellectual Property Laws Bill goes forward – ParlyReportSA
Medical and food intellectual property tackled – ParlyReportSA

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SA to allow avoidance of medical patents

SA copying Brazil by ignoring patents….

pillsGovernment’s Bill on changes to the Intellectual Property Act, not assented to yet by the President but passed by Parliament, is under major attack by overseas pharmaceutical companies who complain that the proposals to allow SA to bypass patent laws are badly drafted; just simply favour local generic manufacturers who have put no R&D into development and further confuse an already obtuse enforcement system of medical patents in South Africa.

Minister of trade and industry, Rob Davies, who was unusually involved in health matters when he recently made statements to the media, “We are the world capital of HIV/AIDS and we have serious burden of TB linked to that … and we have to have the freedom and ability to use the policy space that’s been made available to us under the world health agreement TRIPS ( Trade Related Aspects of Intellectual Property Rights) and public in the interests of the nations that we should take that option.”

South African generics being scouted

However, in this case, the minister was referring to the new government policy on intellectual property (IP), currently under discussion where the minister is saying his department of trade is dealing with “innovative pharmaceutical companies” involved in the production of cheaper drugs. IP is a DTI matter whether it involves health or not.

Briefing journalists on the response to the original draft policy and now the Bill, which elicited submissions representing more than 300 stakeholders, Davies said his department’s fight was “to strike a balance between the needs of public health and the interests of pharmaceutical companies”.

It came out in the questioning with DTI’s spokesperson, MacDonald Netshitenzhe, that the Doha agreement on TRIPS and public health allows countries to break patents by issuing compulsory licences to local manufacturers of generic medicines. These provisions are intended to be used in a public health emergency, and have been used by countries such as Brazil and Thailand to break patents on HIV medicines.

The doctor weighs in with comment

Dr Aaron Motsoaledi, minister of health, has taken the opportunity to declare that South Africa has indeed such an emergency (how much of it caused by the famed past health minister nicked named “minister beetroot” after she called for all to substitute beetroot and garlic for ARV’s aws not mentioned) but minister of trade and industry Rob Davies has added that there are many other areas in health where the poor are not able to begin to afford the menu of drugs on the market.

Commentators are saying  “emergency in HIV/AIDS” referred to by cabinet ministers was caused by government itself in the years of denial over AIDS and quote was activist Zachie Achmat of TAC when  government was refusing to import antiretrovirals (ARVs) some seven years ago, putting South Africa way back in the fight against HIV/AIDS and related diseases such as TB.

Now Zachie Achmat has joined the government call for cheaper drugs and to follow government moves. Other activist groups such as Medicines sans Frontiers have seen the new government policy as an opportunity to push for measures they believe will lower the price of medicines and have said so, particularly influencing Parliament when the matter was in earlier debate there.

An  outcry has grown since the new IP Bill was debated in Parliament, despite the lone voices declaring that the policy that ignoring worldwide patent rights would simply put to risk those investments already made in South Africa by overseas pharmaceuticals.

This charge was led by Wilmot James, shadow minister of trade and industry, and supported, strangely, by ANC Alliance partner, COSATU, for reasons that jobs would be lost.  Wilmot James called the document “remarkably unimpressive”, suggesting “the drafters appear not to fully understand intellectual property law”. Calling the DTI’s document “legally illiterate”, James said that the policy “lives up to the mediocre standard that we have come to accept from the intellectual property division of the department of trade and industry’.

The Doha declaration also allows parallel importation of medicines, which means a company or nongovernmental agency can import a patented drug from another country where the same product is sold at a lower price.

Davies has been quoted by the media as saying “Although we’ve been a major champion of all these processes internationally we haven’t necessarily incorporated them into domestic law. That’s one of the issues that we need to follow through.”

Copyright legislation needed to be brought in line with recent World Intellectual Property Organisation treaties, including the Beijing treaty and the Marrakesh treaty, he said. He was quoted as saying that government was looking at the issue of collective management of royalties in view of complaints from industry stakeholders.

All of this comes in the light of a government health policy to introduce a free national health scheme.  Netshitenzhe of DTI explained that after the public comment period was concluded, the amended document, including comments, will be brought to Cabinet, who may suggest further changes before giving its approval.

Once the policy is finalised, the department of trade and industry will draft legislative amendments to be vetted by Cabinet and Parliament, ideally in March of next year 2014.     Most of the public debate took place in the media whilst Parliament was closed.

Internationals are “satanic” says Motsoaledi

Dr Aaron Motsoaledi weighed in further with the comments to Mail and Guardian, stating “I am not using strong words; I am using appropriate words. This is a conspiracy of “satanic magnitude”, calling on all South Africans to fight “to the last drop of their blood”. Most feel that Motsoaledi will stay as minister of health when the new government is formed in April/May next year.

When the final document re-appears in the public arena in the form of the amended Act in what has become a very heated debate, some watering down may have taken place but what was at first taken to be a simple document protecting indigenous medical practices, has obviously international implications for both local and international partners in the pharmaceutical manufacturing industry and those with head offices outside the country.
Previous articles on this subject

http://parlyreportsa.co.za//finance-economic/intellectual-property-laws-amendment-act-law/
http://parlyreportsa.co.za//finance-economic/promotion-and-protection-of-investment-bill-opens-major-row/
http://parlyreportsa.co.za//health/medical-food-intellectual-property-tackled/
http://parlyreportsa.co.za//uncategorized/next-for-pppfa-preferential-procurement-are-pharmaceuticals/

 

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