[e-drug] India urges African nations over anti-generic laws

e-drug
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E-DRUG: India urges African nations over anti-generic laws
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[The problems with the Kenya anti-counterfeiting Act were earlier discussed in E-drug; the Act has serious negative impact on generics. The issue of counterfeits is real and should be addressed, but African countries should not be confusing counterfeits with possible infringement by generics. Drug companies can use the procedures in the patent law. Drug Regulators should not act as patent police. They are not properly informed about the nuances of patents, and there might be valid reasons why generics enter a country, or be in transit to another country. Copied as fair use. WB]

http://www.pharmatimes.com/WorldNews/article.aspx?id=15911&src=EWorldNews

India urges African nations over anti-generic laws

25 May 2009

By Lynne Taylor

Indian has urged African nations not to follow the example of Kenya,
which has recently passed legislation which allows generic versions of
drugs patented anywhere in the world to be classed as counterfeit if the
patent holder raises an objection.

Earlier this month, the Indian government, along with Brazil, lodged a
complaint with the World Trade Organisation (WTO) against the European
Union (EU), relating to Kenya¹s Anti-Counterfeit Act, which was passed
last December. The Act recognises intellectual property rights on drugs
registered anywhere in the world and, even if a drug is not patented in
Kenya or in the country of manufacture, it will be classified as
counterfeit in Kenya, if the patent holder objects.

India and Brazil¹s complaint to the WTO claims that the new law
represents part of a strategy by EU-based multinational drug
manufacturers aimed at persuading other countries, in Africa and
elsewhere, to enact similar legislation.

The multinationals have failed to get a regime approved the World
Intellectual Property Organisation (WIPO) which would give a patent
granted in a single country worldwide applicability, and they have now
resorted to raising objections to generics while they are in transit in
the EU, en route from India to the purchasing country, and declaring
them to be counterfeits, say Indian government officials.

³Having failed at the WIPO, they are attempting to succeed through the
backdoor by strategically detaining our drugs at ports and convincing
African countries to bring in such legislation,² India¹s Commerce
Secretary, GK Pillai, stated recently.

The seizures were the subject of angry debate at the World Health
Assembly in Geneva earlier this month, where Brazil¹s Health Minister,
Jose Gomes Temporao, described them as ³ethically and legally unacceptable.²

Observers also point out that the Kenyan law¹s definition of a
³counterfeit² medicine differs from that of the World Health
Organisation (WHO), and that it does not differentiate between
³spurious² and ³counterfeit² products.

- Indian pharmaceutical exports had been growing an average rate of
17.8% during the five years to 2008 but, during October 2009-March 2009,
they fell almost 40%. However, in the year to December 2008, Indian drug
exports to the USA soared 46%, year-on-year. African states currently
account for around 14% of India¹s drug export market.

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E-DRUG: India urges African nations over anti-generic laws (2)
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Dear colleagues,

This subject is important on a number of levels, among which counterfeiting is just one, and I am reading the position of Kenya from that point of view. For many governments with limited regulatory capacity, constantly subjected to counterfeit/sub- standard drugs, the issue is not so much about generics. It is about counterfeits, counterfeiting, sub- standard drugs and the risk these pose to public health, safety and welfare. Secondly, I believe any pharmaceutical company that holds a patent, or was the innovator and believes in generics would love to see a true generic drug being mae available. It has to be a true generic drug and must demonstrate bioequivalence, safety, etc. There may be issues on formulation and production processes, etc, but stringent regulators have to satisfy themselves about that aspect, and often they do. You can see why a patent holder would raise an objection: If the a so-called generic perfoms in a manner unlike the original product, there is not only the likelihood of harm to the patient, but that harm might also directly impact negatively on the status of the original (patented) product. You see also the commercial interest from patent holders, as much as clinical concerns. Therefore, I do no think that patent holders would simply raise an objection for the fun of it.

Governments must ensure that any generic drug is worth its salts, and is true to the original drug. Hence, it makes sense for developing countries to be strict on this point: They can enforce patents if that means ensuring public safety, and restricting any so- called generic drug. The onus is on the generic manufacturer to prove the status of that generic drug and so through a stringent review process. Otherwise we shall continue to see the situation where jim and jack company claiming that their generic is true, even when what they produce meets only counterfeit status. Now, for an exporter government to protect acceptance of its generic products for export, the onus also falls on that government to ensure that its regulatory activities are strong, its industry complies and those that do not don't manufacture and supply suspect products. After all, it is in the interest of that exporter country that compliance to standards is strong.

Regards,

Bonnie
Bonface Fundafunda PhD., MBA., B.Pharm
Manager, Drug Supply Budget Line
Ministry of Health,
P.O. Box 30205,
Ndeke House,
Lusaka,
Zambia
Tel: +260 211 25 59 11
Fax: +260 211 25 14 04
Mobile: + 260 979 25 29 00
Email: bcfunda@hotmail.com

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E-DRUG: India urges African nations over anti-generic laws (3)
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Dear Colleagues,

For information, following presentations by various stake holders to the
concerned authorities, the final Kenya anti-counterfeit law (Act No.13 of
2008) did separate the definition of counterfeit medicines from that of
other products.

Under Part I, Section 2(d), the definition for counterfeit medicines is as
follows.

i.e.
d) in relation to medicine, the deliberate and fraudulent mislabelling of
medicine with respect to identity or source, whether or not such products
have correct ingredients, wrong ingredients, have sufficient active
ingredients or have fake packaging;

An on-line copy is available on the following link:
http://www.kenyalaw.org/kenyalaw/klr_app/frames.php.

Regards,

Anastasia Nyalita
Regulatory Affairs Manager BSP
Bayer East Africa Limited
Thika Rd/Outer Ring Rd, Ruaraka,
P O Box 30321,
00100-GPO, NAIROBI, KENYA
Tel.: +254-20-8560667 - 74
Fax: +254-20-8561636 / 8560935
E-Mail: anastasia.nyalita@bayerhealthcare.com
Internet: http://www.bayerscheringpharma.de

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E-DRUG: India urges African nations over anti-generic laws (4)
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Dear e-Druggers,

Bonface's email conflates and confuses two different issues -
counterfeiting, which addresses trademark infringement only, i.e. passing
off a drug as having been made by Pfizer when it was not, and
registration/pharmacovigilance, which addresses the safety, efficacy, and
quality of products throughout the supply chain.

Enforcing patents literally has nothing to do with counterfeiting, which is
purely a trademark issue. Likewise, enforcing trademarks has nothing to do
with safety - enforcing trademarks merely protects a brand owner from
having someone piggyback on its reputation.

Ensuring therapeutic equivalence through bioequivalence studies or
otherwise, ensuring adherence with Good Manufacturing Practices, and
ensuring quality throughout the supply chain all have to do with ensuring
that medicines reaching patients are safe, effective, and of good quality
and with weeding out medicines - from any source - that are substandard.

Big Pharma has succeeded in convincing even pharmacists that combatting
counterfeiting through patent enforcement is a means of quality assurance.
It is not. At its worst, the new counterfeit/IP enforcement agenda is
designed to confuse the public and to deter the trade in legitimate
generics of assured quality and to have customs agents act as patent police
- something they are not competent to do.

regards,

Professor Brook K. Baker, Health GAP
Northeastern U. School of Law
Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115
617-373-3217 (office)
617-259-0760 (cell)

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E-DRUG: India urges African nations over anti-generic laws (5)
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Dear E-Druggers

Bonnie is correct that governments must ensure the quality of generic
medicines. However, having done so, those generic medicines must have
access to the market (both locally and considering those in transit).

Experience we have about the motives of pharmaceutical companies and
business sense tells us that the 'innovator' company holding the
original patent/s (or a licence to manufacture) will not welcome generic
competition and will/may take whatever actions are legally permissible
to prevent competition and loss of market share (and generic companies
may/will do the same against the 'innovator' or other competitors).
Simply delaying the appearance of a generic competitor by months or a
year can result in millions of dollars of revenue which would otherwise
be threatened. If given the opportunity to use trademark and patent
issues to disrupt supplies of competitor products they will do so and we
should not be surprised; that's business. They are not doing it "for the
fun of it" - they are doing it for the bottom line.

This does not distract from the importance of the fight against
fake/counterfeit medicines - but it is important to ensure that the
capacities of governments to address their public health needs are not
threatened by issues which are not related to quality of the medicines.

Regards

Douglas Ball
Pharmaceutical consultant
Public Health and Development
E-mail: douglasball[AT]yahoo.co.uk