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Published online by Cambridge University Press: 20 January 2017
This section updates readers on the latest developments in pharmaceutical law, giving information on legislation and case law on various matters (such as clinical and pre-clinical trials, drug approval and marketing authorisation, the role of regulatory agencies) and providing analysis on how and to what extent they might affect health and security of the individual as well as in industry.
1 Many opt for a comprehensive and rigorous procedure, following the motto “prevention is better than a cure.” This anticipates damage; it does not allow damage to occur, as instead happens in the field of pharmacovigilance. However, even though this procedure is intended to be comprehensive and complex, it will never offer complete assurance of a product not causing adverse effects, especially in the case of high-tech drugs: this is due to the initial lack of information by scientists.
On the other hand – this is another key issue – an excessive delay in granting marketing authorization could cause drugs to reach patients too late.
2 Many member countries have announced mass vaccination of the population. For example, in November 2009, once the drug was approved, France was prepared to vaccinate 70 % of its population, the United Kingdom 50 % and Spain 40 %.
3 The Plan is available on the Internet at the website of AEMPS <http://www.agemed.es/profHumana/farmacovigilancia/planVacunasPandemicas_gripeA_H1N1.htm> (last accessed on 21 October 2010).
4 The Agencia Española de Medicamentos y Productos Sanitarios (commonly abbreviated as AEMPS) is the Spanish Medicines Agency.
5 This plan was complemented with risk management plans that marketing authorisation holders had undertaken to carry out in accordance with the EU guidelines.
6 In Spanish, Sistema Español de Farmacovigilancia (hereinafter SEF).
7 In this study, neurology departments of eleven hospitals belonging to eight autonomous regions participated. The reference population of these hospitals was estimated at 3.9 million.
8 VAESCO is a network of European researchers responsible for conducting epidemiological studies in order to evaluate the vaccines safety. The network is coordinated by the Brighton Collaboration Foundation.
9 One thousand two hundred physicians from nine autonomous regions collaborate on the AEMPS database. BIFAP has a valid population for studies of 1.597.060 people and a monitoring period of four years.
10 The notification should clearly indicate the trade name of the vaccine, the type of presentation, the lot number on the packaging, injection route of administration, the dose of vaccine administered and whether the patient had previously received another vaccination (such as the seasonal flu vaccine). Besides, the practitioner must take into account the medical history of the vaccinated person and whether it had an ALVa.
11 The following are considered adverse events of special interest (AEI): neuritis, seizures, encephalitis, Guillain-Barre syndrome, Bell's palsy, demyelinating disorders, anaphylaxis, vasculitis, and the failure of vaccination confirmed by laboratory test.
12 When the person showing an ALVa is a pregnant woman (ectopic pregnancy, spontaneous abortion, stillbirth, congenital malformation, etc.), the health professional shall indicate the specific gestational week in which she was vaccinated as well as the week in which the adverse effects appeared. If a vaccinated child is the suspected source and is younger than 23 months, the health professional will request his/her weight and height and their exact age in days. The health professional will also expressly indicate whether the referred patient had recently been treated with immunosuppressants.
13 We refer to cases in which the notification of suspected adverse reaction calls for immediate reporting and in which the health professional does not have access to other means of notification. In any case, it will be subsequently validated by completing the corresponding forms.
14 Farmacovigilancia Española, Datos de Reacciones Adversas (commonly abbreviated as FEDRA) is the Spanish pharmacovigilance national database.
15 See the official website of Uppsala Monitoring Centre, a global network on the drug's risks, available on the Internet at <http://www.who-umc.org/>.
16 Mario Chiti, Derecho Administrativo Europeo (Madrid: Civitas 2002), at p. 203. Cfr. also Alessandro Spina, “European networks in the regulation of biotechnologies”, 2 Eur. Law Rev (2010), pp. 197– 213.
17 Gabriel Doménech, Régimen jurídico de la farmacovigilancia (Madrid: Civitas 2009), at p. 123.
18 Council conclusions on Lessons Learned from the A/H1N1 Pandemic – Health Security in the European Union, 3032nd General Affairs, Council meeting Brussels, 13 September 2010, at pp. 6 and 7.
19 Not surprisingly, one of the patient's rights is precisely the socalled “right to epidemiological information”: «Citizens are entitled to know the health problems of the community when involving a risk to public health or to individual health, and the right to this information to be disseminated in real, understandable and appropriate terms for the protection of health, in accordance with legal provisions» (see Article 6 of Spanish Law 41/2002 of November 14th, regulating the patient's autonomy and rights and obligations regarding information and clinical documentation).
20 Cierco, César, “Las medidas preventivas de choque adoptadas por la Administración frente a los productos insalubres”, 175 RAP (2008), pp. 55 et sqq., at p. 75.Google Scholar
21 See the above Lessons Learned from A/H1N1, supra note 18, at p. 7.
22 Idem, p. 7.
23 For example, Sintrom is a drug used by about 800,000 people in Spain and turns its patients into “slaves” due to continuous monthly analyses necessary to recalculate the stipulated dose. This provides a burden for both the patient and the public health system conducting these examinations. Sintrom is an anticoagulant aimed at preventing strokes by patients who already have cardiovascular affections. A third of the consumers of this drug suffer from poor blood circulation. Yet an overdose could cause bleeding and a low dose could provoke a new stroke.
24 In the USA, between October 1976 and January 1977, in view of the alarm generated by the swine flu, 40 million people were administered a vaccine that had been quite quickly approved. As a result, many of them suffered muscle weakness and flaccid paralysis as a side effect (known as Guillain-Barré Syndrome).
25 Lessons Learned from the A/H1N1 Pandemic, supra note 18, at p. 8.
26 Despite the active vaccination policy, there have been 271 deaths in Spain, a country with about 47 million inhabitants. Whereas Poland, with a population of 39 million and a non-vaccination policy, has reported 181 deaths.
27 Spain has considered several possibilities: giving these vaccines to developing countries, reselling them at a lower price, putting them on the market in chemist shops or using them to produce a vaccine for seasonal influenza for the year 2010.
28 Lessons Learned from the A/H1N1 Pandemic, supra note 18, at p. 8. In Spain, this experience led to the modification of the Spanish Law 30/2007 regarding Contracts of the Public Sector, introducing a new provision (number 34th) which allows the centralized acquisition of medicines and sanitary products by the Spanish National Health Service.
29 Lessons Learned from the A/H1N1 Pandemic, supra note 18, p. 7.
30 South Centre is an intergovernmental policy think tank (<http://www.southcentre.org>).
31 These vaccines will be probably thrown away or sold at a very small price to developing countries, where the H1N1 influenza is not a health priority. See Germán Velásquez, “¿Cuánto costó la “vacuna contra la gripe H1N1”?”, Le Monde Diplomatique (Spanish Edition), August 2010, at p. 3.
32 See Francisco Bombillar, “The ‘compassionate exemption’ in Spain: not asking for compassion”, 2 Op.J. (July 2010), paper 1, pp. 1–25, available on the Internet at SSRN <http://ssrn.com/abstract=1647593> and Doménech, Gabriel, “Déficits de transpariencia y participación en los procedimientos de autorización y seguimiento de los medicamentos”, in Barranco, Rafael and Bombillar, Francisco (eds), El acceso al medicamento: retos jurídicos actuales, intervención pública y su vinculación al derecho a la salud (Granada: Comares 2010), pp. 53 et sqq.Google Scholar
33 Lessons Learned from the A/H1N1 Pandemic, supra note 18, pp. 5–8.