[e-drug] Pharmacovigilance and Corruption

e-drug
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E-DRUG: Pharmacovigilance and Corruption
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Dear E-druggers,

Two recent events prompted me to post this message:

1. Transparency International released a report
<http://www.transparency.org.uk/publications/corruption-in-the-pharmaceutical-sector/&gt;
on corruption in the pharmaceutical industry and Sten Olsson from Sweden (a
regular contributor to this forum) tweeted that "corruption fits the WHO
definition of pharmacovigilance" as "other drug related problem."

I retweeted this (@drugsafetyguru) with a question as to who can make the
final ruling on this interesting suggestion to broaden the definition of
pharmacovigilance? Is there a role for the WHO, the World Bank, Global
Fund, DFID, USAID, AusAID, SIDA, JICA, and DANIDA. What are your views on
this suggestion?

2. Last week, I delivered a lecture on pharmacovigilance, its importance,
and its role in improving patient safety in the context of Pakistan at the
Aga Khan University in Karachi. Pakistan is perhaps the only country in
South Asia which doesn't have a functional pharmacovigilance system in
place. After my lecture, one gentleman praised me for raising awareness on
this important topic and asked what was my recommendation to address the
rampant corruption in the country which exists also in the pharmaceutical
industry. His point was that without tackling corruption we can't have a
pharmacovigilance system. Are their examples from resource-limited
settings as to how corruption is/was addressed in their countries?

I look forward to input from more knowledgeable individuals/experts in this
forum on one or both of the above items. Thank you.

Best wishes,

Rizwan

Syed Rizwanuddin Ahmad, MD, MPH, FISPE, FCP
Consultant with a Special Interest in Strengthening National Medicines
Regulatory Authorities in Resource-limited Settings
Ex-Consultant/Safety Reviewer, U.S. FDA (1998-2013)
Associate Professor (adjunct), Rutgers School of Public Health, NJ, USA
Assistant Professor (adjunct), Georgetown University School of Medicine,
Washington, DC, USA
www.drugsafetyconsultant.com
Syed Ahmad <drugsafetyconsultant@gmail.com>

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E-DRUG: Pharmacovigilance and Corruption (2)
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Dear Rizwan,

Please see the report https://drive.google.com/file/d/0B43Z8U_hEFzUTU92eTgybmdxZWs/view?usp=

sharing created within USAID funded project implemented by The All-Ukrainian Network of PLWHA.

The report unveils key corruption and trust schemes detected as a result of continuous monitoring in public procurements of drugs and medical products in Ukraine. The report shows that market of health products procurements that existed before 2015 was mostly oligopolistic, controlled by several big groups, which unduly influenced MoH Ukraine, and almost all bidding procedures where happening with fake competition in collusion between shell companies.

Results of the monitoring described in the report were later used by Network and its partners for future anticorruption interventions to change the situation, which included among others the following:

- transfer of health products procurements of the MoH Ukraine to specialized international procuring organizations (UNDP, UNICEF, Crown Agents) in 2015. This major reform has by now resulted in up to 75 % estimated budget savings and consequent improvement of access to treatment. The procurements are transferred to specialized international procuring organizations until 2019 and give us an opportunity to reform existing state health products procurement system by creation of centralized procurement organization in healthcare;

- introduction of e-procurement system ('ProZorro'), which considerably increased transparency of every public procurement process in Ukraine. Now everyone may monitor all the stages from procurement announcement to actual delivery with the ability to see every document, every change in it, every decision and its justification, as well as agreements, mailings etc. The e-procurement system widens access to tenders for suppliers, as well as introduces a 3-stage bidding reduction procedure. Professional analytical module within the database enables automatic detection of suspicious tenders and considerably simplifies investigations by public authorities, media and civil society organizations.

- introduction of fast-track market authorization procedure for specialized international procuring organizations procurements and for medicines registered by stringent DRAs opens more possibilities for foreign producers to enter Ukrainian market.

Our anti-corruption team would be happy to share more on fighting corruption in healthcare in Ukraine.

Hope this helps!

Kind regards,
Sergiy

Sergiy Kondratyuk
Advocacy Unit
All-Ukrainian Network of PLWH
87 B, Mezhygirska St.,
Kyiv, Ukraine 04080
Tel.: +38 044 467-75-67 (int. 756)
Fax: +38 044 467-75-66
Mob.: +38 067 359 93 23
email: s.kondratyuk@network.org.ua