Tag Archive | medicines

Impasse on intellectual property rights

intellectual property paper awaited….

pills 2Whilst the promised paper on intellectual property (IP) policy remains outstanding, the  argument that South Africa could be a ‘rogue’ state with scant regard for property rights versus the call by local and international activists for drugs which are affordable to poorer families is still wracking the pharmaceutical industry.

The subject was recently re-heated by protests by activists in Pretoria against high drug and medicine costs but still nothing has yet reached Parliament in the form of a serious proposal on government’s stance on pharmaceutical intellectual property rights.

Rights  not tests

What now seems to be the situation is that both manufacturers and activists are calling for a fair and legally correct policy document on intellectual property rights which gives certainty.  At the same time, a claim was made in Parliament some time ago that South Africa just “rubber stamps” patent applications at a vast rate, only 1% going to local innovators.

According to CIPC, the department of trade and industry (DTI) central office that handles registration under DG Astrid Ludin, says the question of registration of patents is proceeding with new vigour but complainants make the point that no actual testing takes place. Ludin, current CEO and IT guru was not in Parliament to make any presentations and who remains “on suspension”, it appears, for some transgression on awarding contracts.

Opinion only

Ludin has an excellent reputation with DTI  and is trying to get things right. Our guess is that she was trying get things done even faster and transgressed some tender procedure but was beaten by the red tape machine.

It appeared some time ago that stakeholders were past the endless argument that South Africa would make the market place unsustainable for pharmaceutical companies with important and much needed drugs if there is disregard for patents lodged after years of painstaking research. But this once again re-emerging as a stated position.

Massive response

Over 100 submissions, it is rumoured, were made on the original Policy IP document when it was first submitted for comment, so one assumes that Dr Rob Davies has a fair assessment on how stakeholders are feeling… but his department still awaiting to tackle the issue, it appears.

Meanwhile, activists have re-opened their claims that “tweaking” of an expired but well established drug takes place and new patent periods sought for twenty years on the same item, which cuts out the possibility of cheaper generics and innovation. Facts presented at recent conferences on the subject have also re-awakened the premise that South Africa is paying more than most developing countries for its drugs.

The background of the delay is provided by a divisive scenario between two government departments – health and trade and industry – the latter department being responsible for the production of the new intellectual property policy stating South Africa’s position.

Cooling waters

Despite the minister of trade and industry, Dr Rob Davies, trying to calm waters with the vague statement of “We are moving in a direction in striking a balance between innovation, affordable medicines and to modernise our intellectual property rights regime”, South Africa’s new intellectual policy seems to be sticking at cabinet level.

It is difficult to disregard the much earlier scandal involving the rumoured attempt by a Washington-based PR company to delay and modify the draft IP Policy, a move which infuriated both the minister and the department of health. The anger of minister of health, Dr Aaron Motsoaledi, was patently obvious at the time and there is no doubt that a sour taste in the mouth is left with many in that department.

TAC returns to the fray

With Treatment Action Campaign and Médecins Sans Frontières ratcheting up their campaigns – the latter specifically naming Pfizer on TB drugs that cost R10 in India and R600 in SA – and DTI’s minister Davies recovering from the impasse on B-BBEE, the much needed IP policy will probably remain on the backburner for a short while longer.

Two things will happen eventually. Either the government publishes a gazette calling for comment on yet a further draft IP policy or an ATC notice is issued by Parliament announcing its tabling as a paper for debate.

Either way, minister Davies is likely to call a media briefing first and not just issue regulations.

Other articles in this category or as background
Intellectual property law still in limbo – ParlyReportSA
Intellectual Property Laws Bill goes forward – ParlyReportSA
Medical and food intellectual property tackled – ParlyReportSA
Medicines Bill: focus on foodstuffs – ParlyReportSA

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South Africa’s IP policy still hidden away

Drug impasse on IP (intellectual property) rights……

patents graphicThe simplistic public platform which is pervading the pharmaceutical debate on the long awaited IP policy – that persistent argument that  South Africa could be a ‘rogue’ state with scant regard for property rights – is constantly coupled with the call by local and international activists for drugs which are affordable to poorer families.

All has been re-heated considerably by protests in Pretoria but nothing has yet reached Parliament in the form of a serious proposal on IP that can be considered by pharmaceutical companies in order to bring certainty.

What now seems to be the situation is that both manufacturers and activists are calling for a fair and legally correct policy document on intellectual property rights which gives certainty but nothing is forthcoming.   At the same time, the claim was made in Parliament some time ago that South Africa just “rubber stamps” patent applications at a vast rate, only 1% going to local innovators.

And yet all know the incredible cost to find a successful HIV/AIDS vaccine. These costs must be recoverable, say pharmaceuticals, or innovation and research will stop. South Africa, like so many countries, is about to step into the unknown.

Problem not with CIPC

According to CIPC the questions of registration of patents is proceeding with new vigour but complainants make the point that no actual testing takes place. Ms Astrid Ludin, current CEO and IT guru was not in Parliament to make any presentations on the specific subject of IP and who remains “on suspension” it appears for some transgression on awarding contracts.

Ludin has an excellent reputation with DTI and in all probability she just wanted to get a job done, at high speed and quickly chose what she thought was the best thing to do. Unfortunately, that is not how red tape works.

Most critical : Invention or intervention?

It appeared some time ago that stakeholders were past the endless argument that South Africa wouldmedicines, pills make the market place unsustainable for pharmaceutical companies with important and much needed drugs if there is disregard for patents lodged after years of painstaking research. But this once again re-emerging.

Over 100 submissions, it is rumoured, were made on the original Policy IP document when it was first submitted for comment, so one assumes that Dr Rob Davies has a fair assessment on how stakeholders are feeling… but his department still refusing to tackle the issue, it appears.

Keeping the same show running

Meanwhile, activists have re-opened their claims that “tweaking” of an expired but well established drug takes place and new patent periods sought for twenty years on the same item, which cuts out the possibility of cheaper generics and innovation. Facts presented at recent conferences on the subject have also re-awakened the premise that South Africa is paying more than most developing countries for drugs.

The background of the delay is provided by a divisive scenario between two government departments – health and trade and industry – the latter department being responsible for the production of the new intellectual property policy stating South Africa’s position.

Too many pokers in fire perhaps

medicine bottleDespite the minister of trade and industry (DTI), Dr Rob Davies, trying to calm waters with the “going nowhere” statement of “We are moving in a direction in striking a balance between innovation, affordable medicines and to modernise our IP regime”, South Africa’s new intellectual policy (IP) policy seems to be sticking at cabinet level.

It is difficult to disregard the much earlier scandal involving the rumoured attempt by a Washington-based PR company to delay and modify the draft IP Policy, a move which infuriated both the minister and the department of health. The anger of minister of health, Dr Aaron Motsoaledi, was patently obvious at the time and there is no doubt that a sour taste in the mouth is left with many in that department.

Has to come to a head

medicines sans frontWith Treatment Action Campaign and Médecins Sans Frontières ratcheting up their campaigns – the latter specifically naming Pfizer on TB drugs that cost R10 in India and R600 in SA – and DTI’s minister Davies at present in the USA arguing on GAT agreements, the much needed IP policy will probably remain on the backburner for a short while longer.

Two things will happen eventually. Either the government publishes a gazette calling for comment on yet a further draft IP policy or an ATC notice is issued by Parliament announcing its tabling as a paper for debate.

Either way, minister Davies is likely to call a media briefing first.

Other articles in this category or as background
Intellectual property law still in limbo – ParlyReportSA
Intellectual Property Laws Bill goes forward – ParlyReportSA
Medical and food intellectual property tackled – ParlyReportSA
Medicines Bill: focus on foodstuffs – ParlyReportSA

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Medicines and Related Substances Bill tabled

Idea is to speed up registration of medicines….

doctorA new Bill has been tabled in Parliament, the Medicines and Related Substances Amendment Bill which proposes to replace the existing Medicines Control Council with a new body that will reflect better, it says, the many changes that have occurred in the industry.

It is proposed that the minister of health and therefore the department (DoH) will  have a far wider scope of regulatory control and adds the expression ‘complimentary medicines’ to its definitions.  The Bill has the intention, DoH says of  speeding up registration of medicines and will allow ‘mutual agreements’ with other worldwide drug registration institutions to enable the process of acceptance or rejection take place.

Committee experts

A new body of committees made up of experts and specialists will assist DoH with such process, the Bill says, but the decision making processes of the committee on the subject of registration of new drugs will still be kept  private as is the case in the principal Act since the proposals are silent on this issue.

The new body will be called the South African Health Products Regulatory Agency (SAHPRA) and according to the proposals will have a far wider regulatory mandate on activities across a broader spectrum of medical products. It will extend the base of control and its services to cover foodstuffs, cosmetics and the newly embraced complimentary medicines.

Business Day reported that experts from the US were assisting in the setting up of SAHPRA but gave no details of where these experts emanated from.
Previous articles in this category
http://parlyreportsa.co.za//health/pharmacies-labour-relations-changes/
http://parlyreportsa.co.za//health/sa-allow-avoidance-medical-patents/

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