Tag Archive | pharmaceutical industry

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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Pharmacies get labour relations changes

More controls for pharmacies to consider…..

pharmacy blacksAn amended set of rules for pharmacies relating to good pharmacy practice  were published for public comment by the South African Pharmacy Council, mainly related to labour relations and supervisory regulations regarding jobs and regulations are forthcoming.

The amendments are made in terms of the Pharmacy Act (1974 and refer to minimum standards and job descriptions for pharmacy technicians, pharmacy technical assistants and pharmacy general assistants.

In amending the “rules of good pharmacy practice”, the procurement, storage and distribution of “thermolabile” pharmaceutical products is set down in terms of cold chain storage; issues such as  pharmacy courier services and even name tagging of pharmacy assistants set out and further regulations regarding the calculation of, dispensing fees outlined.

Pharmacies complain that they recently have been under severe strain recently in the light of new regulations on controlled pricing, with smaller pharmacies under extreme pressure to continue in operation against major retail chains opening dispensaries. The days of the “family chemist” are seeing their last, as owners become more involved in government’s stated policy to reduce the price of medicines.

Now introduced are issues on HIV testing carried out by many pharmacies countrywide. Associated bodies and stakeholders had until late December 2013 to submit public comment. The new regulations are awaited.

previous articles on this subject

http://parlyreportsa.co.za//uncategorized/next-for-pppfa-preferential-procurement-are-pharmaceuticals/

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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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Next for PPPFA preferential procurement are pharmaceuticals

The application of the Preferential Procurement Policy Framework Act (PPPFA)  has resulted in a further move by trade and industry minister Dr Rob Davies regarding the state’s procurement of local products – in this case pharmaceuticals, stipulating that the list of goods (yet to be produced) which are relevant to purchases by govt. departments, agencies and state-owned enterprises.

Davies stated that this move would be of specific benefit to the country both in terms of health and the economy and his list of some seventy products would be made available by the department of trade and industry (DTI) shortly.

The PPPFA was amended last year by the DTI and approved by Parliament to allow for such moves and to stipulate certain sectors of industry and commerce to be controlled in such a manner. Regulations starting with canned vegetable products, commuter buses, clothing textiles and footwear are already in place.

The minister stated that it was important for the state, working with the pharmaceutical industry, to contribute to South Africa’s balance of trade and at the same time make a serious attempt to ensure affordable healthcare to both the private and public sector.

Prices would be “internationally bench marked” he said and government would still source certain supplies from importers where this was necessary.

The list of products that were to apply to the gazetted regulations was compiled only after extensive investigation, he noted.

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